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The Role of Lay Health Workers in Pediatric Chronic Disease: A Systematic Review

      Abstract

      Background

      Children with chronic diseases represent a high-cost and resource-intensive population of children. With continued gaps in chronic disease management and persistent fragmentation in the health care system, stakeholders are seeking new strategies to address the needs of these children.

      Objective

      We sought to systematically assess the effectiveness of lay health worker interventions in improving health care utilization, symptom management, and family psychosocial outcomes for children with chronic conditions.

      Data Source

      PubMed, PsycINFO, and Web of Science (January 1961 to February 2013).

      Study Eligibility Criteria, Participants, and Interventions

      We developed a strategy to search citations to identify relevant articles. Search terms included randomized controlled trial (RCT), lay worker, parent mentor, peer mentor, peer educator, community health workers, community health aids, patient advocate, patient facilitator, patient liaison, promotoras(es), care ambassadors, patient navigator, and nonprofessional. Additional studies were identified by searching the reference lists of retrieved articles and contacting clinical experts. RCTs of lay health worker interventions for children with chronic conditions were included. Studies were restricted to those concentrated on children 0–18 years of age with chronic illnesses.

      Study Appraisal and Synthesis Methods

      Abstracts were independently screened by 2 reviewers. Articles with relevant abstracts underwent full text review and were evaluated for inclusion criteria. A structured tool was used to abstract data from selected articles. Because of the heterogeneous interventions and outcomes, we did not conduct a meta-analysis.

      Results

      The search yielded 736 unique articles, of which 17 met inclusion criteria. All interventions focused on specific conditions: asthma, type I diabetes, obesity, and failure to thrive. Interventions were heterogeneous in frequency, mode, and duration of interactions between lay health workers and subjects. Several interventions were multifaceted, including both one-on-one and group interactions. Improved outcomes most commonly reported were reduced urgent care use, decreases in symptoms, fewer missed work and school days, and increased parental quality of life. One study demonstrated that lay health worker interventions were cost-effective.

      Conclusions

      Lay health workers interventions in children with chronic conditions may lead to modest improvements in urgent care use, symptoms, and parental psychosocial outcomes. Such interventions may also be cost-effective. Future research should focus on interventions targeted toward other chronic conditions such as sickle cell disease or cystic fibrosis and medically complex children whose conditions are noncategorical.

      Keywords

      What This Systematic Review Adds
      • Lay health worker interventions lead to modest improvements in urgent care use, symptoms, and parental psychosocial outcomes.
      • Lay health worker interventions may lead to cost savings.
      • Lay health worker intervention effects may persist after the intervention ends.
      How to Use This Systematic Review
      • Compare and contrast different models of lay health worker interventions.
      • Identify outcome measures most relevant to lay health worker interventions.
      • Findings may be applied to designing interventions or incorporating aspects of lay health worker interventions into practice.
      Children with chronic diseases represent a high-cost and resource-intensive group of children. The prevalence of chronic conditions in children has quadrupled in the past 4 decades, now comprising 12–16% of the pediatric population.
      • Newacheck P.W.
      • Halfon N.
      Prevalence and impact of disabling chronic conditions in childhood.
      • van Dyck P.C.
      • Kogan M.D.
      • McPherson M.G.
      • et al.
      Prevalence and characteristics of children with special health care needs.
      • Perrin J.M.
      • Bloom S.R.
      • Gortmaker S.L.
      The increase of childhood chronic conditions in the United States.
      • Bethell C.D.
      • Read D.
      • Blumberg S.J.
      • Newacheck P.W.
      What is the prevalence of children with special health care needs? Toward an understanding of variations in findings and methods across three national surveys.
      The impact of pediatric chronic diseases on child health-related cost is enormous with respect to health care utilization, school and work absenteeism, and family functioning.
      • Perrin J.M.
      • Bloom S.R.
      • Gortmaker S.L.
      The increase of childhood chronic conditions in the United States.
      • van der Lee J.H.
      • Mokkink L.B.
      • Grootenhuis M.A.
      • et al.
      Definitions and measurement of chronic health conditions in childhood: a systematic review.
      • Newacheck P.W.
      • Inkelas M.
      • Kim S.E.
      Health services use and health care expenditures for children with disabilities.
      • Reichman N.E.
      • Corman H.
      • Noonan K.
      Effects of child health on parents’ relationship status.
      • Cooley W.C.
      • McAllister J.W.
      Building medical homes: improvement strategies in primary care for children with special health care needs.
      Minority and low-income children with chronic diseases are particularly vulnerable as they experience inequities in access to care, utilization, unmet medical needs, and patient satisfaction.
      • Newacheck P.W.
      • Hung Y.Y.
      • Wright K.K.
      Racial and ethnic disparities in access to care for children with special health care needs.
      • Ngui E.M.
      • Flores G.
      Satisfaction with care and ease of using health care services among parents of children with special health care needs: the roles of race/ethnicity, insurance, language, and adequacy of family-centered care.
      There is mounting concern that the current model of pediatric primary care is not equipped to support the provision of high-quality care for chronically ill children.
      • Wise P.H.
      The future pediatrician: the challenge of chronic illness.
      • Halfon N.
      • DuPlessis H.
      • Inkelas M.
      Transforming the US child health system.
      • Wise P.H.
      The transformation of child health in the United States.
      With continued gaps in chronic disease management and persistent fragmentation in the health care system, policy makers, clinicians, and other stakeholders are seeking new strategies to promote partnership models of care in which patients take a more active role in their own management.
      • Coulter A.
      Paternalism or partnership? Patients have grown up—and there’s no going back.
      • Foster G.
      • Taylor S.J.C.
      • Eldridge S.
      • et al.
      Self-management education programmes by lay leaders for people with chronic conditions.
      • Hibbard J.H.
      • Greene J.
      • Tusler M.
      Improving the outcomes of disease management by tailoring care to the patient’s level of activation.
      Increasing evidence suggests that patients with chronic diseases may potentially benefit from individualized assistance to navigate the health care system.
      • Foster G.
      • Taylor S.J.C.
      • Eldridge S.
      • et al.
      Self-management education programmes by lay leaders for people with chronic conditions.
      • Dohan D.
      • Schrag D.
      Using navigators to improve care of underserved patients: current practices and approaches.
      • Postma J.
      • Karr C.
      • Kieckhefer G.
      Community health workers and environmental interventions for children with asthma: a systematic review.
      • Greene J.
      • Hibbard J.H.
      Why does patient activation matter? An examination of the relationships between patient activation and health-related outcomes.
      Lay health worker interventions (eg, community health workers, patient navigators) for chronic disease have emerged as innovative models of individualized care. Lay health workers are individuals who perform functions related to health care delivery.
      • Lewin S.
      • Munabi-Babigumira S.
      • Glenton C.
      • et al.
      Lay health workers in primary and community health care for maternal and child health and the management of infectious diseases.
      Because they have no formal or paraprofessional training, they are typically provided with informal job-related training. They may work in paid positions or as volunteers. The term lay health workers is broad in scope and could include community health workers, village health workers, and cancer supporters. Although heterogeneous in specific content and delivery, lay health workers programs provide flexible and tailored one-on-one guidance to individuals. Previous studies among adults indicate that such interventions improve diabetes knowledge, hypertension management, timeliness of cancer care, health care utilization, and patient satisfaction.
      • Norris S.L.
      • Chowdhury F.M.
      • Van Le K.
      • et al.
      Effectiveness of community health workers in the care of persons with diabetes.
      • Brownstein J.N.
      • Chowdhury F.M.
      • Norris S.L.
      • et al.
      Effectiveness of community health workers in the care of people with hypertension.
      • Andrews J.O.
      • Felton G.
      • Wewers M.E.
      • Heath J.
      Use of community health workers in research with ethnic minority women.
      • Wells K.J.
      • Battaglia T.A.
      • Dudley D.J.
      • et al.
      Patient navigation: state of the art or is it science?.
      • Freund K.M.
      • Battaglia T.A.
      • Calhoun E.
      • et al.
      National Cancer Institute Patient Navigation Research Program: methods, protocol, and measures.
      Although numerous individual studies have assessed lay health worker interventions in pediatrics, there is little consensus about the effectiveness of such programs for children with chronic conditions.
      • Postma J.
      • Karr C.
      • Kieckhefer G.
      Community health workers and environmental interventions for children with asthma: a systematic review.
      Previous reviews of lay health worker interventions have been adult focused, disease specific, or limited to outcomes in preventive care.
      • Foster G.
      • Taylor S.J.C.
      • Eldridge S.
      • et al.
      Self-management education programmes by lay leaders for people with chronic conditions.
      • Postma J.
      • Karr C.
      • Kieckhefer G.
      Community health workers and environmental interventions for children with asthma: a systematic review.
      • Lewin S.
      • Munabi-Babigumira S.
      • Glenton C.
      • et al.
      Lay health workers in primary and community health care for maternal and child health and the management of infectious diseases.
      • Viswanathan M.
      • Kraschnewski J.
      • Nishikawa B.
      • et al.
      Outcomes of Community Health Worker Interventions.
      For example, a prior review of lay health worker interventions among children narrowly focused on asthma with heavy emphasis on environmental controls. Evidence for the effectiveness of these interventions among a broad spectrum of children with chronic conditions is needed, particularly with respect to health care use, symptom management, and family psychosocial outcomes. The objectives of this study were to summarize the available studies on lay health worker interventions, determine the efficacy of such programs for children with chronic conditions, and identify gaps in current knowledge regarding efficacy.

      Methods

      Eligibility Criteria

      We searched for randomized controlled trials (RCT) of interventions that were delivered by lay health workers to families of children 18 years of age or younger with chronic health conditions. Lay health workers were identified as individuals who were specifically trained to deliver a health-related intervention but who had no formal professional or paraprofessional training in health care. A lay health worker could not be a family member trained to provide care or support exclusively for members of his or her family. Because by definition lay health workers deliver one-on-one guidance, interventions had to have one-on-one interactions between the lay health worker and family. All RCTs were included, regardless of type. We excluded studies that focused on adults, studies evaluating pediatric to adult transition, nonempirical work such as case studies or commentaries, and unpublished literature. From included studies, we extracted data on characteristics, theoretical frameworks, training, intervention types, outcomes, and cost-effectiveness.

      Information Sources

      We conducted a systematic search of 3 major electronic databases comprising medical and social science studies (PubMed, PsycINFO, and Web of Knowledge) for titles and abstracts relevant to our research question (January 1961 to February 2013). We additionally hand searched bibliographies from retrieved articles and from published reviews. Local experts in behavioral interventions were consulted for additional studies. We did not contact study authors for further details with respect to methodology or reporting of results.

      Search Terms

      On the basis of our inclusion/exclusion criteria, we started with Medical Subject Headings (MeSH) and the following keyword search terms: lay worker, parent mentor, peer mentor, community health worker, and promotoras(es). We added more terms by identifying keywords associated with these searches or within articles found with these searches. The final compiled list of search terms consisted of the following keywords or keyword combinations: lay worker, parent mentor, peer mentor, peer educator, community health workers, community health aids, patient advocate, patient facilitator, patient liaison, promotoras(es), care ambassadors, patient navigator, and nonprofessional.

      Study Selection

      Publications were screened and selected in a 2-step process in order to minimize bias. In the first phase, publications were screened for inclusion independently by 2 investigators (JR and AR) using titles of articles and, if available, the abstracts derived from the search. The inclusion criteria were RCTs of lay health worker interventions among children with chronic conditions. In the second phase, full text of articles that met inclusion criteria were retrieved and independently reviewed by JR and AR. The investigators met regularly to discuss the design and validity of the studies to determine whether they met inclusion criteria. Any disagreements were resolved by consensus between investigators.

      Data Collection Process

      We developed a data extraction document based on the Cochrane Consumers and Communication Review Group’s data extraction template,

      Cochrane Consumers and Communication Review Group. Available at: http://www.latrobe.edu.au/chcp/cochrane/resources.html. Accessed November 2, 2012.

      pilot tested it on 10 included studies, and refined it accordingly. JR and AR independently collected the following data elements from the included studies: design, trial inclusion and exclusion criteria, condition type, population characteristics, setting, theoretical framework, lay health worker training, and intervention type (including duration and frequency).

      Assessment of Risk of Bias of Included Studies

      The methodological risk of bias of included studies was assessed in accordance with the Cochrane Handbook and the guidelines of the Cochrane Consumers and Communication Review Group,

      Ryan R, Hill S, Prictor M, McKenzie J; Cochrane Consumers and Communication Review Group. Study quality guide. May 2011. Available at: http://www.latrobe.edu.au/chcp/cochrane/resources.html. Accessed April 10, 2013.

      which recommends the explicit reporting of the following individual elements for RCTs: random sequence generation; allocation sequence concealment; blinding (participants, personnel); blinding (outcome assessment); completeness of outcome data, selective outcome reporting; and other sources of bias. JR and AR independently assessed the risk of bias of all included studies, with any disagreements resolved by discussion and consensus.

      Summary Measures

      Given that there are no standard outcome measures for lay health worker interventions, we did not prespecify or place limitations on the outcomes examined. We used all outcomes for each study. To minimize bias, we only report results from prespecified analyses and do not include findings of post hoc analyses.

      Results

      Results of the Search

      The literature review yielded 736 unique articles, of which 27 articles met criteria for initial review (Fig.). After abstract review, 10 of the 27 studies were excluded because they did not meet inclusion criteria: 8 articles were eliminated as a result of nonrandomized design and 2 were eliminated because the study design did not include one-on-one interaction with the lay health workers. The final group of 17 studies comprised 4 specific pediatric chronic conditions: asthma, type I diabetes, obesity, and failure to thrive (FTT). The heterogeneity of interventions and outcomes precluded us from conducting any meta-analysis.
      Figure thumbnail gr1
      FigureFlow of titles, abstracts, and articles included in review.

      Quality of Studies

      None of the studies scored low risk of bias in all of the 7 items assessed (Table 1). Six studies were rated high risk in at least one category of risk of bias. These articles were rated low risk or unclear risk in all other categories and were therefore deemed appropriate to include in the review. However, the results of included studies are stratified according to whether or not they rate as high risk in any categories. Certain quality limitations were common in most articles. Three-quarters of the articles did not adequately describe the allocation concealment process. Because of the design of the interventions, which required the lay health workers to have face-to-face contact with the subjects, it was impossible to blind the study participants and personnel. Of all the articles, 8 stated that the outcome assessment was blinded; 2 stated that the outcome assessment was not blinded; and the rest of the articles made no statement regarding blinding of the outcome assessment.
      Table 1Risk of Bias for Included Studies
      Topic and Study (Year)Random Sequence GenerationAllocation Sequence ConcealmentBlinding (Participants, Personnel)Blinding (Outcome Assessment)Completeness of Outcome DataSelective Outcome ReportingOther Bias
      Asthma
       Bryant-Stephens (2009)UnclearUnclearNAUnclearLow riskLow riskLow risk
       Flores (2009)Low riskUnclearNALow riskLow riskLow riskLow risk
       Krieger (2005)Low riskLow riskNAUnclearLow riskLow riskLow risk
       Bryant-Stephens (2008)UnclearUnclearNAUnclearLow riskLow riskLow risk
       Parker (2008)
      High risk of bias in 1 or more quality category.
      Low riskUnclearNAUnclearLow riskLow riskHigh risk; physician aware of intervention status
       Williams (2006)UnclearUnclearNAUnclearLow riskUnclearLow risk
       Eggleston (2005)
      High risk of bias in 1 or more quality category.
      Low riskUnclearNALow riskLow riskUnclearHigh risk; groups told purpose of study
       Krieger (2009)Low riskLow riskNALow riskLow riskLow riskLow risk
       McConnell (2005)
      High risk of bias in 1 or more quality category.
      UnclearLow riskNAHigh risk; not blindedLow riskLow riskLow risk
       Morgan (2004)
      High risk of bias in 1 or more quality category.
      Low riskUnclearNAHigh risk; interviewers could see study materials in homeLow riskLow riskLow risk
       Bonner (2002)UnclearUnclearNALow riskLow riskLow riskLow risk
      Diabetes
       Sullivan-Bolyai (2011)
      High risk of bias in 1 or more quality category.
      High risk; fathers assigned to intervention to which wife randomizedUnclearNAUnclearUnclearLow riskLow risk
       Sullivan-Bolyai (2010)Low riskUnclearNAUnclearLow riskLow riskLow risk
       Svoren (2003)UnclearUnclearNALow riskLow riskLow riskUnclear
       Laffel (1998)Low riskLow riskNALow riskLow riskLow riskLow risk
      Obesity
       Resnick (2009)
      High risk of bias in 1 or more quality category.
      UnclearUnclearNALow riskLow riskLow riskHigh risk; lengthy enrollment process likely attracted motivated participants
      Failure to Thrive
       Black (1995)Low riskUnclearNALow riskLow riskLow riskLow risk
      NA = not applicable.
      High risk of bias in 1 or more quality category.

      Study Characteristics

      Theoretical frameworks for lay health worker interventions documented in 10 of 17 studies
      • Krieger J.
      • Takaro T.K.
      • Song L.
      • et al.
      A randomized controlled trial of asthma self-management support comparing clinic-based nurses and in-home community health workers: the Seattle–King County Healthy Homes II Project.
      • Parker E.A.
      • Israel B.A.
      • Robins T.G.
      • et al.
      Evaluation of Community Action Against Asthma: a community health worker intervention to improve children’s asthma-related health by reducing household environmental triggers for asthma.
      • Williams S.G.
      • Brown C.M.
      • Falter K.H.
      • et al.
      Does a multifaceted environmental intervention alter the impact of asthma on inner-city children?.
      • Eggleston P.A.
      • Butz A.
      • Rand C.
      • et al.
      Home environmental intervention in inner-city asthma: a randomized controlled clinical trial.
      • Krieger J.W.
      • Takaro T.K.
      • Song L.
      • Weaver M.
      The Seattle–King County Healthy Homes Project: a randomized, controlled trial of a community health worker intervention to decrease exposure to indoor asthma triggers.
      • Morgan W.J.
      • Crain E.F.
      • Gruchalla R.S.
      • et al.
      Results of a home-based environmental intervention among urban children with asthma.
      • Bonner S.
      • Zimmerman B.J.
      • Evans D.
      • et al.
      An individualized intervention to improve asthma management among urban Latino and African-American families.
      • Sullivan-Bolyai S.
      • Bova C.
      • Lee M.
      • Gruppuso P.A.
      Mentoring fathers of children newly diagnosed with T1DM.
      • Sullivan-Bolyai S.
      • Bova C.
      • Leung K.
      • et al.
      Social Support to Empower Parents (STEP): an intervention for parents of young children newly diagnosed with type 1 diabetes.
      • Black M.M.
      • Dubowitz H.
      • Hutcheson J.
      • et al.
      A randomized clinical trial of home intervention for children with failure to thrive.
      included social cognitive theory, self-efficacy theory, and social support theory. All studies were 2- or 3-arm RCTs conducted in urban areas (Table 2), and 3 of the 17 studies were multicenter trials.
      • Morgan W.J.
      • Crain E.F.
      • Gruchalla R.S.
      • et al.
      Results of a home-based environmental intervention among urban children with asthma.
      • Sullivan-Bolyai S.
      • Bova C.
      • Lee M.
      • Gruppuso P.A.
      Mentoring fathers of children newly diagnosed with T1DM.
      • Sullivan-Bolyai S.
      • Bova C.
      • Leung K.
      • et al.
      Social Support to Empower Parents (STEP): an intervention for parents of young children newly diagnosed with type 1 diabetes.
      The included studies involved 3,806 children 0–18 years old, with the majority of the study populations having a mean age of 5–8 years, and the total study size ranging from 46 to 937 children. The subjects were followed between 3 and 24 months after intervention. Most studies targeted minority populations of low socioeconomic status. Subjects were recruited from schools, outpatient clinics, and emergency departments (ED).
      Table 2Study Characteristics
      Primary Author (Year), Study DesignNTarget PopulationEligibility RequirementsRecruitment
      Asthma
       Bryant-Stephens (2009), 2-arm RCT264Urban minority, low SES2–16 y old; physician diagnosed; on controller medication; ≥1 hospitalization or ≥2 ED visits within 12 moSelf-referral or from physician
       Flores (2009), 2-arm RCT220Urban minority2–18 y old; AA/LA; asthma as primary ED or hospital diagnosis;ED or inpatient service at 4 local hospitals
       Krieger (2009), 2-arm RCT271Low SES;3–13 y old; persistent or poorly controlled asthma; income <200% FPL or on MedicaidCommunity and public health clinics
       Bryant-Stephens (2008), 3-arm RCT281Urban minority2–16 y old; receive primary care at Children’s Hospital of Philadelphia; ≥1 hospitalization or ≥2 ED visits within 12 moSelf-referral or from physician
       Parker (2008), 2-arm RCT
      High risk of bias in 1 or more quality category.
      298Low SES, minority, near industrial facilities7–11 y old; persistent asthmaSchools
       Williams (2006), 2-arm RCT161Low SES federally designated census tract5–12 y old; ≥1 ED visitED of local children’s hospital
       Eggleston (2005), 2-arm RCT
      High risk of bias in 1 or more quality category.
      97Inner city children6–12 y old; physician diagnosed; current symptomsGraduates of school-based asthma education program
       Krieger (2005), 2-arm RCT274Ethnically diverse urban children4–12 y old; persistent asthma; income <200% FPL or on MedicaidCommunity and public health clinics
       McConnell (2005), 2-arm RCT
      High risk of bias in 1 or more quality category.
      150Urban Hispanic children6–14 y old; ≥3 outpatient visits; persistent asthma; positive skin test for allergensSchool-based mobile asthma clinic; allergy clinic
       Morgan (2004), 2-arm RCT
      High risk of bias in 1 or more quality category.
      937Census tracts with high proportion of low SES households5–11 y old; physician diagnosed; ≥20% of households in census tract had incomes below FPLResearch centers
       Bonner (2002), 2-arm RCT119Urban African American and Hispanic childrenAge criteria NR; asthma; established care for previous 12 moGeneral pediatric practice or pulmonary clinic of university hospital
      Type 1 Diabetes
       Sullivan-Bolyai (2011), 2-arm RCT
      High risk of bias in 1 or more quality category.
      28No specificationAge <13 y; newly diagnosedDiabetes center
       Sullivan-Bolyai (2010), 2-arm RCT60No specificationAge <13 y; newly diagnosedDiabetes center
       Svoren (2003), 3-arm RCT299No specification7–16 y old; diabetes >6 mo; ≥1 outpatient visit to diabetes center in last 12 moDiabetes center
       Laffel (1998), 2-arm RCT171No specification10–15 y old; diabetes >12 mo; ≥1 outpatient visit to diabetes center in last 12 moDiabetes center
      Obesity
       Resnick (2009), 2-arm RCT
      High risk of bias in 1 or more quality category.
      46No specificationAge criteria NR; BMI ≥85 percentile; enrolled at 1 of 2 study schools; K–5th gradeSchool
      Failure to Thrive
       Black (1995), 2-arm RCT130Low-income children<25 mo of age; weight for age <5 percentile; gestational age ≥36 wk; weight appropriate for gestational agePediatric clinics; community health maintenance organizations
      AA/LA = African American/Latino American; BMI = body mass index; ED = emergency department; FPL = federal poverty limit; NR = not reported; SES = socioeconomic status.
      High risk of bias in 1 or more quality category.

      Lay Health Worker Training Characteristics

      In most studies, lay health workers were chosen on the basis of social congruence with the study population according to race/ethnicity, socioeconomic status, or having a child with the same chronic condition. All of the lay health workers received training before beginning the study intervention, although 7 studies
      • Krieger J.
      • Takaro T.K.
      • Song L.
      • et al.
      A randomized controlled trial of asthma self-management support comparing clinic-based nurses and in-home community health workers: the Seattle–King County Healthy Homes II Project.
      • Williams S.G.
      • Brown C.M.
      • Falter K.H.
      • et al.
      Does a multifaceted environmental intervention alter the impact of asthma on inner-city children?.
      • Eggleston P.A.
      • Butz A.
      • Rand C.
      • et al.
      Home environmental intervention in inner-city asthma: a randomized controlled clinical trial.
      • Krieger J.W.
      • Takaro T.K.
      • Song L.
      • Weaver M.
      The Seattle–King County Healthy Homes Project: a randomized, controlled trial of a community health worker intervention to decrease exposure to indoor asthma triggers.
      • Morgan W.J.
      • Crain E.F.
      • Gruchalla R.S.
      • et al.
      Results of a home-based environmental intervention among urban children with asthma.
      • Bryant-Stephens T.
      • Li Y.
      Outcomes of a home-based environmental remediation for urban children with asthma.
      • Laffel L.M.
      • Brackett J.
      • Ho J.
      • Anderson B.J.
      Changing the process of diabetes care improves metabolic outcomes and reduces hospitalizations.
      did not describe training details (Table 3). Six studies
      • Parker E.A.
      • Israel B.A.
      • Robins T.G.
      • et al.
      Evaluation of Community Action Against Asthma: a community health worker intervention to improve children’s asthma-related health by reducing household environmental triggers for asthma.
      • Bonner S.
      • Zimmerman B.J.
      • Evans D.
      • et al.
      An individualized intervention to improve asthma management among urban Latino and African-American families.
      • Bryant-Stephens T.
      • Kurian C.
      • Guo R.
      • Zhao H.
      Impact of a household environmental intervention delivered by lay health workers on asthma symptom control in urban, disadvantaged children with asthma.
      • Flores G.
      • Bridon C.
      • Torres S.
      • et al.
      Improving asthma outcomes in minority children: a randomized, controlled trial of parent mentors.
      • McConnell R.
      • Milam J.
      • Richardson J.
      • et al.
      Educational intervention to control cockroach allergen exposure in the homes of Hispanic children in Los Angeles: results of the La Casa study.
      • Resnick E.A.
      • Bishop M.
      • O’Connell A.
      • et al.
      The CHEER study to reduce BMI in elementary school students: a school-based, parent-directed study in Framingham, Massachusetts.
      reported oversight by trained professionals or use of protocols to maintain the quality, accuracy, and consistency of the lay health worker interventions.
      Table 3Intervention Characteristics
      Primary Author (Year)Lay Health Worker TrainingContentModeDose/FrequencyIntervention LengthAssessment FrequencyControl Group Study Protocol
      Asthma
       Bryant-Stephens (2009)Didactic training with practice assessmentsHome education and environmental interventionHVActive phase: biweekly visits for 24 wk; inactive phase: monthly visits for 6 mo12 moMonthly for 12 moObservation (crossover)
       Flores (2009)Training for 2.5 d; training manualAsthma education; peer supportHV, phone calls; group meetings2 HV/y; monthly phone calls12 moMonthly for 12 moObservation only
       Krieger (2009)NRAction plan development; review of educational topics; social supportHV, phone callsInitial visit plus 0–5 follow up visits (mean 3.1)12 moAt 12 moClinic visits with asthma nurses
       Bryant-Stephens (2008)NRAsthma education; review of medications and asthma action plan; pest controlHVAssessment HV + 5 weekly follow-up visits, then 1 HV/mo to collect symptom diaries, review medications and action plans12 moAt 12 moGiven information about asthma self-management classes
       Parker (2008)
      High risk of bias in 1 or more quality category.
      4-wk training programAction plan development; asthma and trigger educationHVMean 9.24 (range 1–17) HV in 1 y12 moAt 12 moObservation only
       Williams (2006)NREducation and assistance on asthma management; environmental interventionHV, phone callsHV and phone calls at 0, 4, 8, and 12 mo12 mo4, 8, 12 moDelayed intervention
       Eggleston (2005)
      High risk of bias in 1 or more quality category.
      NREducation on avoiding allergens; modeling on how to reduce exposuresHV, phone callsThree HV at 0, 6, and 12 mo, and quarterly phone calls during 12 mo period12 mo3, 6, 9, 12 moObservation only
       Krieger (2005)NRSupport, education, resources to reduce exposuresHVMean of 7 visits/y12 mo12, 18 moSingle visit
       McConnell (2005)
      High risk of bias in 1 or more quality category.
      Urban health education for immigrants; Allergy and Asthma Foundation of AmericaEducation modules on remediation of exposure to indoor allergensHV2 HV in 4 mo4 moAt 4 moObservation only
       Morgan (2004)
      High risk of bias in 1 or more quality category.
      NREducation modules on remediation of exposure to indoor allergensHV, phone callsMedian of 5 HV (range, 0–7)12 mo6, 12, 18, 24 moObservation only
       Bonner (2002)One month training by pulmonary division and project coordinatorSocial support; asthma diary monitoring; family coaching; reduction of triggersHV, phone calls, accompanied family to clinic visits, group workshopsPhone calls; workshops once a month; 3 HV; 1–2 doctor visit accompaniments3 moAt 3 moObservation only
      Type 1 Diabetes
       Sullivan-Bolyai (2011)
      High risk of bias in 1 or more quality category.
      Parent mentor curriculumEducation; affirmation and emotional supportHV, phone calls, e-mailAverage of 5 parent contacts in 1 y12 mo3, 6, 12 moContact information for experienced parent
       Sullivan-Bolyai (2010)Parent mentor curriculumEducation; affirmation and emotional supportHV, phone calls, e-mailAverage of 5 (range 1–25) contacts in 1 y12 mo3, 6, 12 moContact information for experienced parent
       Svoren (2003)Training by research and medical staffCA group received information on scheduling clinic visits with monitoring of clinic attendance; CA+ group received 8 written teaching modules over 2 y about type 1 DM careSessions in the clinic by CACA group, mean of 7.3 visits in 24 mo; CA+ group, mean of 7.5 visits in 24 mo24 mo4, 8, 12, 24 moDelayed intervention
       Laffel (1998)NRCA assisted with appt scheduling, monitored clinic attendance and contacted families who missed their appointmentsIn-clinic visits, phone calls, lettersFollowed patients for 24 mo24 moEvery visit for 24 moObservation only
      Obesity
       Resnick (2009)
      High risk of bias in 1 or more quality category.
      36 h trainingEvidence- based counseling on dietary changes, reducing TV viewing, increasing physical activityHV, phone calls, e-mailAverage personal encounters 3.4/12 mo12 moAt 12 moEducational materials via mail
      Failure to Thrive
       Black (1995)8 session trainingHawaii Early Learning ProgramHVRange of 0–49 visits in 1 y, mean of 19.2/y (SD 11.5)12 moAt 12 moClinic-based multidisciplinary services
      CA = care ambassador; ED = emergency department; HV = home visit; NR = not reported.
      High risk of bias in 1 or more quality category.

      Interventions

      Interventions consisted of lay health worker-family interactions through home visits, phone calls, or e-mails (Table 3). The services provided by lay health workers varied across studies. The lay health workers in the 11 studies of asthma primarily focused on education about environmental trigger reduction, provision of engineering controls (eg, air filters, mattress encasements), asthma action plans, medication management, and increasing parental recognition of symptoms. Two asthma interventions involved monthly group meetings in the community.
      • Bonner S.
      • Zimmerman B.J.
      • Evans D.
      • et al.
      An individualized intervention to improve asthma management among urban Latino and African-American families.
      • Flores G.
      • Bridon C.
      • Torres S.
      • et al.
      Improving asthma outcomes in minority children: a randomized, controlled trial of parent mentors.
      Of the 4 studies addressing type I diabetes care, 2 focused on peer parental support and education,
      • Sullivan-Bolyai S.
      • Bova C.
      • Lee M.
      • Gruppuso P.A.
      Mentoring fathers of children newly diagnosed with T1DM.
      • Sullivan-Bolyai S.
      • Bova C.
      • Leung K.
      • et al.
      Social Support to Empower Parents (STEP): an intervention for parents of young children newly diagnosed with type 1 diabetes.
      and 2 studies involved clinic-based care ambassadors who made efforts to improve clinic attendance and follow-up visits to clinic by phone or letters.
      • Laffel L.M.
      • Brackett J.
      • Ho J.
      • Anderson B.J.
      Changing the process of diabetes care improves metabolic outcomes and reduces hospitalizations.
      • Svoren B.M.
      • Butler D.
      • Levine B.S.
      • et al.
      Reducing acute adverse outcomes in youths with type 1 diabetes: a randomized, controlled trial.
      The single study on children with FTT focused on providing emotional support and modeling healthy parent-child behavior.
      • Black M.M.
      • Dubowitz H.
      • Hutcheson J.
      • et al.
      A randomized clinical trial of home intervention for children with failure to thrive.
      The single study on children with high risk body mass index (BMI) centered primarily on nutritional education.
      • Resnick E.A.
      • Bishop M.
      • O’Connell A.
      • et al.
      The CHEER study to reduce BMI in elementary school students: a school-based, parent-directed study in Framingham, Massachusetts.
      The frequency of interactions between the lay health workers and the subjects varied among studies and was inconsistently reported. Most of the studies did not report the duration of individual encounters.

      Study Findings

      Results were stratified according to the following categories: studies that rated low risk or unclear risk in all risk of bias elements and studies that had any element rated as high risk. Given the heterogeneity of outcomes assessed and analyses performed, standardized measures of intervention effect could not be reported across the different studies. We present the most informative measures of effect and statistical confidence available from the published studies (Table 4).
      Table 4Findings
      Study (Year)Psychosocial/Behavior OutcomesSymptoms/Medication UseUrgent Care Use
      Asthma
       Bryant-Stephens (2009)No difference in knowledgeNo difference in nighttime cough, wheeze, or albuterol useNo difference in ED visits or hospitalizations
       Flores (2009)Increased know when serious breathing problem controllable at home; 0.7 unit increase, P = .02; no differences in QOL, asthma satisfactionFewer rapid breathing episodes/mo; 57.3 to 41.5, P = .04; fewer asthma exacerbations/mo; 2.9 to 1.8, P = .01; fewer wheezing episodes/mo; 92 to 60, P = .01; fewer missed parental work days/mo; 2.9 to 0.3, P = .01; fewer missed school days/mo; 3.7 to 0.8, P = .03Fewer ED visits/y; 0.5 to 0.1, P = .03; no differences for hospitalizations, urgent care visits
       Krieger (2009)Increase in mean caregiver QOL score; 5.6 to 6.2, P < .001; no differences in behavior changeIncrease in no. of symptom-free days/2 wk; IE 0.94 (0.02–1.86) or 24.4 more days/y; no differences in missed work or school daysNo differences in urgent services use
       Bryant-Stephens (2008)Not assessedNo differences in symptoms or medication useNo differences in ED visits or hospitalizations
       Parker (2008)
      High risk of bias in 1 or more quality category.
      Fewer caregiver depressive symptoms; 1.62 to 1.5, P value not reportedIncreased nadir PF; IE 8.2 (1.1–15.2); increased nadir FEV1; IE 10.0 (0.9–19.1); fewer bouts of persistent cough; 3.81 to 3.36; decrease in cough with exercise; 4.27 to 3.69; decrease in any symptoms for more than 2 d/wk and no controller medication; IE 0.39 (0.20–0.73)Less unscheduled urgent care; IE for last 12 mo 0.40 (0.22–0.74); IE for last 3 mo 0.43 (0.23–0.80)
       Williams (2006)Not assessedLower asthma functional severity score; 33% to 20%, P < .01Not assessed
       Eggleston (2005)
      High risk of bias in 1 or more quality category.
      Not assessedFewer daytime symptoms/9 mo; treatment group OR 0.55 (0.31–0.97) compared to controlNo differences
       Krieger (2005)Increased caregiver QOL score; IE 0.58 (0.18–0.99)Fewer no. of days’ activity limitations/2 wk; IE −1.5 (−2.84 to −0.15); no differences in symptoms; no differences in missed work or school daysLess urgent health services use/2 wk; IE −0.97 (−1.8 to −0.12)
       McConnell (2005)
      High risk of bias in 1 or more quality category.
      No differencesNot assessedNot assessed
       Morgan (2004)
      High risk of bias in 1 or more quality category.
      Not assessedFewer no. of days with symptoms/2 wk; −0.82, P < .0001 at 12 mo; −0.60, P < .0001 at 24 mo; fewer caretaker nights wakening/2 wk; −0.61, P < .0001 at 12 mo; −0.37, P = .006 at 24 mo; days caretaker plans changed/2 wk; −0.31, P < .0001 at 12 mo; fewer missed school days/2 wk; −0.17, P = .003 at 12 mo; −0.17, P = .009 at 24 moFewer no. of visits/y to ED or clinic; −0.35, P = .04 at 12 mo
       Bonner (2002)Increased asthma knowledge, P < .001; increased self-efficacy for managing asthma, P < .001Less symptom persistence, P < .01; fewer activity restrictions, P < .01; increased family adherence, P < .001; increased prophylactic use of bronchodilator, P < .05; increased physician pharmacotherapy, P < .001Not assessed
      Type 1 Diabetes
       Sullivan-Bolyai (2011)
      High risk of bias in 1 or more quality category.
      Increase in father confidence related to managing DM, P = .02; no differences in paternal concern, worry, DM impact, perceived amount and helpfulness of daily managementNot assessedNot assessed
       Sullivan-Bolyai (2010)No differences in parental concern, worry, confidence, DM impact on familyNot assessedNot assessed
       Svoren (2003)Not assessedLower rate of severe hypoglycemic events 45.4/100 patient-y in CA+ vs 60.6/100 patient-y in SC plus CA, P = .02; fewer severe hypoglycemic events requiring parenteral therapy; 4.2/100 patient-y in CA+ vs 10.5/100 patient-y in SC plus CA, P = .01; increase in risk of worsening glycemic control; SC plus CA 3.4 times higher compared to CA+, P = .002Increased mean no. of clinic follow-up visits at 24 mo in both intervention groups; CA 7.3, CA+ 7.5, SC 5.4, P = .0001; less hospitalization; 8.9/100 patient-y in CA+ vs 15.3/100 patient-y in SC plus CA, P = .04; fewer ED visits; 21/100 patient-y in CA+ vs 34.9/100 patient-y in SC plus CA, P = .004
       Laffel (1998)Not assessedLower rate of severe hypoglycemic events; 10.1/100 patient-y vs 22.5/100 patient-y, P = .009Fewer ED visits or hospitalizations; 10.6/100 patient-y vs 20.5/100 patient-y, P = .034; increased mean no. of clinic visits/24 mo; 7.1 visits for intervention vs 5.2 for control, P = .0001
      Obesity
       Resnick (2009)
      High risk of bias in 1 or more quality category.
      No differences in parent confidence; no differences in behaviorNo differences in BMINot assessed
      Failure to Thrive
       Black (2005)Not assessedNo differences in weightNot assessed
      CA = care ambassador; ED = emergency department; FEV1 = forced expiratory volume at 1 second; IE = intervention effect; PF = peak expiratory flow; QOL = quality of life; SC = standard care; BMI = body mass index.
      Confidence intervals are provided in parentheses. The term “difference” refers to statistically significant differences for intervention group relative to control.
      High risk of bias in 1 or more quality category.

      Asthma (Low or Unclear Risk in All Categories)

      Of the 7 studies that rated low or unclear risk in all categories,
      • Krieger J.
      • Takaro T.K.
      • Song L.
      • et al.
      A randomized controlled trial of asthma self-management support comparing clinic-based nurses and in-home community health workers: the Seattle–King County Healthy Homes II Project.
      • Williams S.G.
      • Brown C.M.
      • Falter K.H.
      • et al.
      Does a multifaceted environmental intervention alter the impact of asthma on inner-city children?.
      • Krieger J.W.
      • Takaro T.K.
      • Song L.
      • Weaver M.
      The Seattle–King County Healthy Homes Project: a randomized, controlled trial of a community health worker intervention to decrease exposure to indoor asthma triggers.
      • Bonner S.
      • Zimmerman B.J.
      • Evans D.
      • et al.
      An individualized intervention to improve asthma management among urban Latino and African-American families.
      • Bryant-Stephens T.
      • Li Y.
      Outcomes of a home-based environmental remediation for urban children with asthma.
      • Bryant-Stephens T.
      • Kurian C.
      • Guo R.
      • Zhao H.
      Impact of a household environmental intervention delivered by lay health workers on asthma symptom control in urban, disadvantaged children with asthma.
      • Flores G.
      • Bridon C.
      • Torres S.
      • et al.
      Improving asthma outcomes in minority children: a randomized, controlled trial of parent mentors.
      4 reported decreased asthma symptoms in the intervention group versus control,
      • Krieger J.
      • Takaro T.K.
      • Song L.
      • et al.
      A randomized controlled trial of asthma self-management support comparing clinic-based nurses and in-home community health workers: the Seattle–King County Healthy Homes II Project.
      • Williams S.G.
      • Brown C.M.
      • Falter K.H.
      • et al.
      Does a multifaceted environmental intervention alter the impact of asthma on inner-city children?.
      • Bonner S.
      • Zimmerman B.J.
      • Evans D.
      • et al.
      An individualized intervention to improve asthma management among urban Latino and African-American families.
      • Flores G.
      • Bridon C.
      • Torres S.
      • et al.
      Improving asthma outcomes in minority children: a randomized, controlled trial of parent mentors.
      and 3 reported no significant differences between the groups (Table 4).
      • Krieger J.W.
      • Takaro T.K.
      • Song L.
      • Weaver M.
      The Seattle–King County Healthy Homes Project: a randomized, controlled trial of a community health worker intervention to decrease exposure to indoor asthma triggers.
      • Bryant-Stephens T.
      • Li Y.
      Outcomes of a home-based environmental remediation for urban children with asthma.
      • Bryant-Stephens T.
      • Kurian C.
      • Guo R.
      • Zhao H.
      Impact of a household environmental intervention delivered by lay health workers on asthma symptom control in urban, disadvantaged children with asthma.
      The study by Flores et al showed a decrease in rapid breathing episodes per month (57.3 to 41.5) in the intervention but not control group.
      • Flores G.
      • Bridon C.
      • Torres S.
      • et al.
      Improving asthma outcomes in minority children: a randomized, controlled trial of parent mentors.
      This study also demonstrated significant reductions in asthma exacerbations per year (2.9 to 1.8) in the intervention but not control group. The study by Krieger et al reported an increase in symptom-free days by 24.4 days/year in the intervention group.
      • Krieger J.
      • Takaro T.K.
      • Song L.
      • et al.
      A randomized controlled trial of asthma self-management support comparing clinic-based nurses and in-home community health workers: the Seattle–King County Healthy Homes II Project.
      Two studies reported decreased activity limitation in the intervention group compared to control group.
      • Krieger J.W.
      • Takaro T.K.
      • Song L.
      • Weaver M.
      The Seattle–King County Healthy Homes Project: a randomized, controlled trial of a community health worker intervention to decrease exposure to indoor asthma triggers.
      • Bonner S.
      • Zimmerman B.J.
      • Evans D.
      • et al.
      An individualized intervention to improve asthma management among urban Latino and African-American families.
      Two of the studies reported decreased use of urgent health services (ie, ED or clinic visits),
      • Krieger J.W.
      • Takaro T.K.
      • Song L.
      • Weaver M.
      The Seattle–King County Healthy Homes Project: a randomized, controlled trial of a community health worker intervention to decrease exposure to indoor asthma triggers.
      • Flores G.
      • Bridon C.
      • Torres S.
      • et al.
      Improving asthma outcomes in minority children: a randomized, controlled trial of parent mentors.
      and of the remaining five, 3 studies reported no significant differences in urgent health services use after the intervention,
      • Krieger J.
      • Takaro T.K.
      • Song L.
      • et al.
      A randomized controlled trial of asthma self-management support comparing clinic-based nurses and in-home community health workers: the Seattle–King County Healthy Homes II Project.
      • Bryant-Stephens T.
      • Li Y.
      Outcomes of a home-based environmental remediation for urban children with asthma.
      • Bryant-Stephens T.
      • Kurian C.
      • Guo R.
      • Zhao H.
      Impact of a household environmental intervention delivered by lay health workers on asthma symptom control in urban, disadvantaged children with asthma.
      and 2 did not include urgent care use as an outcome.
      • Williams S.G.
      • Brown C.M.
      • Falter K.H.
      • et al.
      Does a multifaceted environmental intervention alter the impact of asthma on inner-city children?.
      • Bonner S.
      • Zimmerman B.J.
      • Evans D.
      • et al.
      An individualized intervention to improve asthma management among urban Latino and African-American families.
      Three studies assessed the impact of lay health worker interventions on school and work attendance.
      • Krieger J.
      • Takaro T.K.
      • Song L.
      • et al.
      A randomized controlled trial of asthma self-management support comparing clinic-based nurses and in-home community health workers: the Seattle–King County Healthy Homes II Project.
      • Krieger J.W.
      • Takaro T.K.
      • Song L.
      • Weaver M.
      The Seattle–King County Healthy Homes Project: a randomized, controlled trial of a community health worker intervention to decrease exposure to indoor asthma triggers.
      • Flores G.
      • Bridon C.
      • Torres S.
      • et al.
      Improving asthma outcomes in minority children: a randomized, controlled trial of parent mentors.
      In the study by Flores et al, the mean number of school days missed by the child in the past month decreased by 2.9 days.
      • Flores G.
      • Bridon C.
      • Torres S.
      • et al.
      Improving asthma outcomes in minority children: a randomized, controlled trial of parent mentors.
      The mean number of work days missed by the parent decreased by 2.6 days. The remaining 2 studies assessing school and work days did not show significant differences between intervention and control groups.
      • Krieger J.
      • Takaro T.K.
      • Song L.
      • et al.
      A randomized controlled trial of asthma self-management support comparing clinic-based nurses and in-home community health workers: the Seattle–King County Healthy Homes II Project.
      • Krieger J.W.
      • Takaro T.K.
      • Song L.
      • Weaver M.
      The Seattle–King County Healthy Homes Project: a randomized, controlled trial of a community health worker intervention to decrease exposure to indoor asthma triggers.
      Five of the 7 studies assessed psychosocial or behavior outcomes among caregivers.
      • Krieger J.
      • Takaro T.K.
      • Song L.
      • et al.
      A randomized controlled trial of asthma self-management support comparing clinic-based nurses and in-home community health workers: the Seattle–King County Healthy Homes II Project.
      • Krieger J.W.
      • Takaro T.K.
      • Song L.
      • Weaver M.
      The Seattle–King County Healthy Homes Project: a randomized, controlled trial of a community health worker intervention to decrease exposure to indoor asthma triggers.
      • Bonner S.
      • Zimmerman B.J.
      • Evans D.
      • et al.
      An individualized intervention to improve asthma management among urban Latino and African-American families.
      • Bryant-Stephens T.
      • Kurian C.
      • Guo R.
      • Zhao H.
      Impact of a household environmental intervention delivered by lay health workers on asthma symptom control in urban, disadvantaged children with asthma.
      • Flores G.
      • Bridon C.
      • Torres S.
      • et al.
      Improving asthma outcomes in minority children: a randomized, controlled trial of parent mentors.
      Four studies reported improvement in at least one measurable or observable outcome.
      • Krieger J.
      • Takaro T.K.
      • Song L.
      • et al.
      A randomized controlled trial of asthma self-management support comparing clinic-based nurses and in-home community health workers: the Seattle–King County Healthy Homes II Project.
      • Krieger J.W.
      • Takaro T.K.
      • Song L.
      • Weaver M.
      The Seattle–King County Healthy Homes Project: a randomized, controlled trial of a community health worker intervention to decrease exposure to indoor asthma triggers.
      • Bonner S.
      • Zimmerman B.J.
      • Evans D.
      • et al.
      An individualized intervention to improve asthma management among urban Latino and African-American families.
      • Flores G.
      • Bridon C.
      • Torres S.
      • et al.
      Improving asthma outcomes in minority children: a randomized, controlled trial of parent mentors.
      Improved outcomes included caregiver quality of life and caregiver depressive symptoms. The study by Bonner et al reported a 41% increase in participant self-efficacy for managing asthma versus only a 9% increase in the control group.
      • Bonner S.
      • Zimmerman B.J.
      • Evans D.
      • et al.
      An individualized intervention to improve asthma management among urban Latino and African-American families.

      Asthma (High Risk of Bias in at Least 1 Category)

      Of the 4 studies that rated high risk in at least one risk of bias element,
      • Parker E.A.
      • Israel B.A.
      • Robins T.G.
      • et al.
      Evaluation of Community Action Against Asthma: a community health worker intervention to improve children’s asthma-related health by reducing household environmental triggers for asthma.
      • Eggleston P.A.
      • Butz A.
      • Rand C.
      • et al.
      Home environmental intervention in inner-city asthma: a randomized controlled clinical trial.
      • Morgan W.J.
      • Crain E.F.
      • Gruchalla R.S.
      • et al.
      Results of a home-based environmental intervention among urban children with asthma.
      • McConnell R.
      • Milam J.
      • Richardson J.
      • et al.
      Educational intervention to control cockroach allergen exposure in the homes of Hispanic children in Los Angeles: results of the La Casa study.
      3 reported decreased asthma symptoms in the intervention group versus control group,
      • Parker E.A.
      • Israel B.A.
      • Robins T.G.
      • et al.
      Evaluation of Community Action Against Asthma: a community health worker intervention to improve children’s asthma-related health by reducing household environmental triggers for asthma.
      • Eggleston P.A.
      • Butz A.
      • Rand C.
      • et al.
      Home environmental intervention in inner-city asthma: a randomized controlled clinical trial.
      • Morgan W.J.
      • Crain E.F.
      • Gruchalla R.S.
      • et al.
      Results of a home-based environmental intervention among urban children with asthma.
      and 1 study did not assess asthma symptoms.
      • McConnell R.
      • Milam J.
      • Richardson J.
      • et al.
      Educational intervention to control cockroach allergen exposure in the homes of Hispanic children in Los Angeles: results of the La Casa study.
      Parker et al demonstrated that, over 12 months, the proportion of the intervention group that needed unscheduled clinic visits decreased by 6%, whereas the control group’s unscheduled visits increased by 15%.
      • Parker E.A.
      • Israel B.A.
      • Robins T.G.
      • et al.
      Evaluation of Community Action Against Asthma: a community health worker intervention to improve children’s asthma-related health by reducing household environmental triggers for asthma.
      In the study by Morgan et al, there were significant reductions in the disruption of caretakers’ plans and school days missed by the children in the intervention group.
      • Morgan W.J.
      • Crain E.F.
      • Gruchalla R.S.
      • et al.
      Results of a home-based environmental intervention among urban children with asthma.
      One of 2 studies assessing psychosocial or behavior outcomes among caregivers showed significant findings.
      • Parker E.A.
      • Israel B.A.
      • Robins T.G.
      • et al.
      Evaluation of Community Action Against Asthma: a community health worker intervention to improve children’s asthma-related health by reducing household environmental triggers for asthma.
      • McConnell R.
      • Milam J.
      • Richardson J.
      • et al.
      Educational intervention to control cockroach allergen exposure in the homes of Hispanic children in Los Angeles: results of the La Casa study.
      Parker et al demonstrated a decrease in depressive symptoms in the intervention group relative to the control group.
      • Parker E.A.
      • Israel B.A.
      • Robins T.G.
      • et al.
      Evaluation of Community Action Against Asthma: a community health worker intervention to improve children’s asthma-related health by reducing household environmental triggers for asthma.

      Type I Diabetes

      Of the 2 studies assessing parental psychosocial outcomes,
      • Sullivan-Bolyai S.
      • Bova C.
      • Lee M.
      • Gruppuso P.A.
      Mentoring fathers of children newly diagnosed with T1DM.
      • Sullivan-Bolyai S.
      • Bova C.
      • Leung K.
      • et al.
      Social Support to Empower Parents (STEP): an intervention for parents of young children newly diagnosed with type 1 diabetes.
      the study with low or unclear risk of bias in all categories showed no differences in parental concern, worry, confidence, or diabetes impact on family.
      • Sullivan-Bolyai S.
      • Bova C.
      • Leung K.
      • et al.
      Social Support to Empower Parents (STEP): an intervention for parents of young children newly diagnosed with type 1 diabetes.
      The study which rated high risk of bias in one category showed that fathers increased their confidence related to managing their child’s diabetes.
      • Sullivan-Bolyai S.
      • Bova C.
      • Lee M.
      • Gruppuso P.A.
      Mentoring fathers of children newly diagnosed with T1DM.
      The 2 studies assessing clinic outcomes rated low or unclear risk in all risk of bias elements.
      • Laffel L.M.
      • Brackett J.
      • Ho J.
      • Anderson B.J.
      Changing the process of diabetes care improves metabolic outcomes and reduces hospitalizations.
      • Svoren B.M.
      • Butler D.
      • Levine B.S.
      • et al.
      Reducing acute adverse outcomes in youths with type 1 diabetes: a randomized, controlled trial.
      The studies by Laffel et al and Svoren et al measured severe hypoglycemic events, glycemic control, outpatient clinic visits, and emergency care visits and hospitalizations.
      • Laffel L.M.
      • Brackett J.
      • Ho J.
      • Anderson B.J.
      Changing the process of diabetes care improves metabolic outcomes and reduces hospitalizations.
      • Svoren B.M.
      • Butler D.
      • Levine B.S.
      • et al.
      Reducing acute adverse outcomes in youths with type 1 diabetes: a randomized, controlled trial.
      Both of these studies reported improved glycemic control in the intervention groups. In addition, both reported increased outpatient clinic attendance and a decrease in hospitalization and ED visits for the intervention group. In the study by Laffel et al, appointment attendance in the diabetes clinic improved with a mean of 7.1 visits/24 months for the intervention group compared to 5.2 visits/24 months for the control group.

      Obesity

      The study by Resnick et al (high risk in one category) reported a modest reduction of children’s BMI percentile. The mean BMI percentile decreased from 94.1 to 90.6 at the end of the 12-month intervention for all children (intervention and control).
      • Resnick E.A.
      • Bishop M.
      • O’Connell A.
      • et al.
      The CHEER study to reduce BMI in elementary school students: a school-based, parent-directed study in Framingham, Massachusetts.
      There were no differences in BMI reductions between groups.

      Failure to Thrive

      The lay health worker intervention in the study by Black et al (low or unclear risk in all categories) resulted in improved growth parameters for children with FTT regardless of intervention status.
      • Black M.M.
      • Dubowitz H.
      • Hutcheson J.
      • et al.
      A randomized clinical trial of home intervention for children with failure to thrive.

      Long-Term Intervention Effects

      Two studies related to asthma assessed the sustainability of intervention outcomes. In the study by Krieger et al (low or unclear risk of bias in all categories), the sustainability of the intervention outcome was assessed 6 months after exit from the intervention group.
      • Krieger J.W.
      • Takaro T.K.
      • Song L.
      • Weaver M.
      The Seattle–King County Healthy Homes Project: a randomized, controlled trial of a community health worker intervention to decrease exposure to indoor asthma triggers.
      Improvements in caregiver quality of life, urgent care use, and days with activity limitation were all sustained. The control group was not followed because members of this group crossed over and received the intervention. In the study by Morgan et al (high risk of bias in 1 category), sustained intervention effects (relative to control) were observed 12 months after exit for caretaker nighttime wakening, missed school days, and number of days with symptoms.
      • Morgan W.J.
      • Crain E.F.
      • Gruchalla R.S.
      • et al.
      Results of a home-based environmental intervention among urban children with asthma.

      Cost-Effectiveness and Cost Savings

      Two studies (both low or unclear risk of bias in all categories) examined cost-effectiveness or cost savings of lay health worker interventions. In the study by Flores et al,
      • Flores G.
      • Bridon C.
      • Torres S.
      • et al.
      Improving asthma outcomes in minority children: a randomized, controlled trial of parent mentors.
      the average monthly cost of the intervention per patient was $60.42. The intervention group experienced savings of $361.48 for hospitalizations and $50.33 for ED encounters. The mean reduction in asthma exacerbation days was 1.26 days for the intervention group and 0.78 for the control group. The incremental cost-effectiveness ratio for the intervention group was −$597.10 per asthma exacerbation-free day gained, indicating a total cost savings for the intervention group. In the 2005 study by Krieger et al, the estimated marginal cost of the high-intensity intervention relative to the low-intensity intervention was $1124 per child.
      • Krieger J.W.
      • Takaro T.K.
      • Song L.
      • Weaver M.
      The Seattle–King County Healthy Homes Project: a randomized, controlled trial of a community health worker intervention to decrease exposure to indoor asthma triggers.
      The savings in urgent care costs (ED visits, hospitalization, and unscheduled clinic visits) during a 2-month period was calculated to range from $57 to $80 per child.

      Discussion

      The evidence for lay health worker interventions improving the care of children with chronic conditions is generally positive according to this review. Benefits of interventions included reduced urgent health care use, decreased symptoms, improved child health status, fewer missed parental work days, fewer missed child school days, improved parental quality of life, and increased self-efficacy. However, these findings were not consistent across all studies. Two studies demonstrated that intervention effects may be sustained long after the intervention ends. Additional studies indicated that lay health worker interventions may offer cost savings. Current data are limited to outcomes among a small number of specific diseases. In our review, the majority of interventions were conducted in asthma with far fewer in diabetes, obesity, and FTT. Overall, the current evidence suggests that lay health worker interventions may provide an important strategy for improving care and therefore warrant further study.
      This work adds to the findings of previous reviews of lay health worker interventions.
      • Foster G.
      • Taylor S.J.C.
      • Eldridge S.
      • et al.
      Self-management education programmes by lay leaders for people with chronic conditions.
      • Postma J.
      • Karr C.
      • Kieckhefer G.
      Community health workers and environmental interventions for children with asthma: a systematic review.
      • Lewin S.
      • Dick J.
      • Pond P.
      • et al.
      Lay health workers in primary care and community health care.
      A review by Foster et al assessed the effectiveness of lay-led self management programs for adults with chronic conditions.
      • Foster G.
      • Taylor S.J.C.
      • Eldridge S.
      • et al.
      Self-management education programmes by lay leaders for people with chronic conditions.
      This review included 17 trials involving 7442 participants. It concluded that lay health worker interventions led to modest, short-term improvements in patients’ confidence to manage their condition and perceptions of their own health without altering health care utilization or quality of life. A review by Postma et al specifically assessed the effectiveness of community health worker interventions for children with asthma.
      • Postma J.
      • Karr C.
      • Kieckhefer G.
      Community health workers and environmental interventions for children with asthma: a systematic review.
      Seven studies with 2,316 participants were examined. The review found positive outcomes associated with lay health worker interventions, including decreased asthma symptoms, day-time activity limitations, and urgent care use. Six of the studies in the review by Postma were among the 11 included in our review. A most recent review conducted by the Agency for Healthcare Research and Quality on adults and children concluded that evidence of the effectiveness of lay health worker interventions is mixed.
      • Viswanathan M.
      • Kraschnewski J.
      • Nishikawa B.
      • et al.
      Outcomes of Community Health Worker Interventions.
      The development of innovative and effective care delivery mechanisms for children with chronic conditions has evolved as a central priority in redefining pediatric practice. Various models of care (eg, medical homes, comprehensive hospital-based care programs) have been implemented with limited evidence and variable results.
      • Homer C.J.
      • Cooley W.C.
      • Strickland B.
      Medical home 2009: what it is, where we were, and where we are today.
      • Cohen E.
      • Jovcevska V.
      • Kuo D.Z.
      • Mahant S.
      Hospital-based comprehensive care programs for children with special health care needs: a systematic review.
      • Raphael J.L.
      • Zhang Y.
      • Liu H.
      • et al.
      Association of medical home care and disparities in emergency care utilization among children with special health care needs.
      • Raphael J.L.
      • Mei M.
      • Brousseau D.C.
      • Giordano T.P.
      Associations between quality of primary care and health care use among children with special health care needs.
      In adult care, newer lay health worker interventions have provided insights on how to facilitate timely, high-quality care for those with chronic conditions. Most recently, patient navigation has emerged as an innovative care model with the principal function of eliminating barriers to timely delivery of services for individual patients across the health care continuum.
      • Wells K.J.
      • Battaglia T.A.
      • Dudley D.J.
      • et al.
      Patient navigation: state of the art or is it science?.
      • Freeman H.P.
      • Rodriguez R.L.
      History and principles of patient navigation.
      Although patient navigation includes components grounded in self-efficacy and social support theories similar to lay health worker interventions, it also incorporates practical assistance to achieve desired outcomes. It has its conceptual and theoretical roots in cancer care where it was developed in order to support and guide adults with abnormal cancer screening or a new cancer diagnosis.
      • Freund K.M.
      • Battaglia T.A.
      • Calhoun E.
      • et al.
      National Cancer Institute Patient Navigation Research Program: methods, protocol, and measures.
      Patient navigators are non–health workers who target at-risk populations such as racial/ethnic minorities and those from low-income populations for delays in care.
      • Dohan D.
      • Schrag D.
      Using navigators to improve care of underserved patients: current practices and approaches.
      • Guadagnolo B.A.
      • Boylan A.
      • Sargent M.
      • et al.
      Patient navigation for American Indians undergoing cancer treatment: utilization and impact on care delivery in a regional healthcare center.
      • Burhansstipanov L.
      • Wound D.B.
      • Capelouto N.
      • et al.
      Culturally relevant “Navigator” patient support. The Native Sisters.
      Positive outcomes associated with patient navigation have included timeliness of diagnosis, time to initiation of primary therapy, patient satisfaction, quality of life, and cost-effectiveness.
      • Freund K.M.
      • Battaglia T.A.
      • Calhoun E.
      • et al.
      National Cancer Institute Patient Navigation Research Program: methods, protocol, and measures.
      • Battaglia T.A.
      • Roloff K.
      • Posner M.A.
      • Freund K.M.
      Improving follow-up to abnormal breast cancer screening in an urban population. A patient navigation intervention.
      • Guadagnolo B.A.
      • Cina K.
      • Koop D.
      • et al.
      A pre–post survey analysis of satisfaction with health care and medical mistrust after patient navigation for American Indian cancer patients.
      • Guadagnolo B.A.
      • Dohan D.
      • Raich P.
      Metrics for evaluating patient navigation during cancer diagnosis and treatment: crafting a policy-relevant research agenda for patient navigation in cancer care.
      Patient navigation may represent a new model for lay health worker intervention for children in the future.
      This review had several strengths. These included a focus on children with chronic conditions, inclusion of conditions other than asthma, and incorporation of more current studies. The inclusive search strategy and rigorous evaluation of risk of bias have resulted in a comprehensive and critical assessment of the current state of the science for lay health worker interventions. However, limitations to this review also merit discussion. Although the individual studies assessed a diverse set of outcomes, they did little in providing a theoretical basis for improvements. Only 10 of the 17 studies cited specific conceptual models that informed the interventions. Of the studies that did use conceptual models, few operationalized theoretical concepts in such a way that the mediators of behavioral change could be identified. For example, if an intervention resulted in improved quality of life, it could not be determined which element of the intervention led to the change. Therefore it was not possible to summarize the individual elements of the causal pathways that led to improvements. As more lay health worker or patient navigation interventions are developed, more attention must be directed toward the operationalization of the theoretical models underpinning these interventions and analysis of which elements lead to improvements. Only 2 studies in this review examined costs. Though both studies documented cost-savings, they did not rigorously assess cost-effectiveness as recommended for such studies.
      • Gold M.R.
      • Siegel J.E.
      • Russell L.B.
      • et al.
      Cost-Effectiveness in Health and Medicine.
      • Haddix A.
      • Teutsch S.M.
      • Corso P.S.
      Prevention Effects: A Guide to Decision Analysis and Economic Evaluation.
      Most studies were limited to a small set of chronic conditions in urban populations. Future studies should focus on other chronic conditions and different settings (eg, rural).
      There were also limitations inherent to the review methodology. The gray literature (evaluation of theses, dissertations, or unpublished work) was not included in the search as a result of limitations in resources. The studies that met the inclusion criteria were heterogeneous with varied medical conditions, designs, interventions, and outcome measures. The reporting of results by individual studies also varied widely with authors reporting intervention effects, percentage changes, or simply P values to demonstrate outcomes. These differences limited comparisons among studies. Given the heterogeneity of outcomes, we could not construct a funnel plot to assess publication bias or perform a meta-analysis. Future studies should report intervention effects with confidence intervals and all elements of study design that could lead to systematic bias.

      Policy Implications

      Although statistically significant positive outcomes of lay health worker interventions have been demonstrated, the clinical benefits are relatively small in scale. Though any improvement is noteworthy, a critical question for policy makers will be whether this scale of improvement will make any appreciable impact on costs associated with management of pediatric chronic disease, particularly when there is increasing emphasis on identifying interventions to produce cost savings. Even if lay health worker interventions do result in cost savings, the returns might not go to those who fund the programs but might be realized by other parties. Therefore, cost savings must be considered from the perspective of all stakeholders, both within and outside the health care system. This determination may better elucidate which entities should be most invested in funding these programs (eg, hospitals, insurers, or employers). Aside from cost, another challenge to implementation of lay health worker interventions will be the current dynamic context of health care. Increasing focus on health literacy and technology-based interventions may change the role of lay health workers, as well as how they communicate with patients.

      Conclusions

      Lay health worker interventions are emerging as innovative models of care for individuals with chronic conditions, especially those from minority and low socioeconomic backgrounds. Many of the pediatric studies of lay health worker interventions report modest positive results including reduced health care use, decreased symptoms, and improved parental quality of life. Gaps in knowledge remain regarding the long-term sustainability of these benefits or cost-effectiveness of such programs. Core metrics must be identified to elucidate the impact of lay health worker interventions on children with chronic conditions. Lay health worker interventions should be further assessed in other specific conditions such as sickle cell disease and cystic fibrosis as well as among medically complex children who have multiple diagnoses and medical needs. Because most lay health worker studies have been conducted in urban areas, more trials in rural areas are warranted.

      Conflict of Interest

      The authors declare that they have no conflict of interest.

      Acknowledgments

      Supported in part by a grant to JLR ( NIH grant 1K23 HL105568-01A1 ).

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