Integrating Community Health Workers' Dual Clinic-Community Role in Safety-Net Primary Care: Implementation Lessons from a Pragmatic Diabetes-Prevention Trial.

BACKGROUND: Over a third of US adults carry a diagnosis of prediabetes, 70% of whom may progress to type 2 diabetes mellitus ("diabetes"). Community health workers (CHWs) can help patients undertake healthy behavior to prevent diabetes. However, there is limited guidance to integrate CHWs in primary care, specifically to address CHWs' dual clinic-based and community-oriented role. OBJECTIVE: Using evidence from CHWs' adaptations of a diabetes-prevention intervention in safety-net hospitals in New York City, we examine the nature, intent, and possible consequences of CHWs' actions on program fidelity. We propose strategies for integrating CHWs in primary care. DESIGN: Case study drawing on the Model for Adaptation Design and Impact (MADI) to analyze CHWs' actions during implementation of CHORD (Community Health Outreach to Reduce Diabetes), a cluster-randomized pragmatic trial (2017-2022) at Manhattan VA and Bellevue Hospital. PARTICIPANTS: CHWs and clinicians in the CHORD study, with a focus in this analysis on CHWs. APPROACH: Semi-structured interviews and focus group discussion with CHWs (n=4); semi-structured interviews with clinicians (n=17). Interpretivist approach to explain CHWs' adaptations using a mix of inductive and deductive analysis. KEY RESULTS: CHWs' adaptations extended the intervention in three ways: by extending social assistance, healthcare access, and operational tasks. The adaptations were intended to improve fit, reach, and retention, but likely had ripple effects on implementation outcomes. CHWs' focus on patients' complex social needs could divert them from judiciously managing their caseload. CONCLUSIONS: CHWs' community knowledge can support patient engagement, but overextension of social assistance may detract from protocolized health-coaching goals. CHW programs in primary care should explicitly delineate CHWs' non-health support to patients, include multiprofessional teams or partnerships with community-based organizations, establish formal communication between CHWs and clinicians, and institute mechanisms to review and iterate CHWs' work to resolve challenges in their community-oriented role.

Implementation fidelity to a behavioral diabetes prevention intervention in two New York City safety net primary care practices.

BACKGROUND: It is critical to assess implementation fidelity of evidence-based interventions and factors moderating fidelity, to understand the reasons for their success or failure. However, fidelity and fidelity moderators are seldom systematically reported. The study objective was to conduct a concurrent implementation fidelity evaluation and examine fidelity moderators of CHORD (Community Health Outreach to Reduce Diabetes), a pragmatic, cluster-randomized, controlled trial to test the impact of a Community Health Workers (CHW)-led health coaching intervention to prevent incident type 2 Diabetes Mellitus in New York (NY). METHODS: We applied the Conceptual Framework for Implementation Fidelity to assess implementation fidelity and factors moderating it across the four core intervention components: patient goal setting, education topic coaching, primary care (PC) visits, and referrals to address social determinants of health (SDH), using descriptive statistics and regression models. PC patients with prediabetes receiving care from safety-net patient-centered medical homes (PCMHs) at either, VA NY Harbor or at Bellevue Hospital (BH) were eligible to be randomized into the CHW-led CHORD intervention or usual care. Among 559 patients randomized and enrolled in the intervention group, 79.4% completed the intake survey and were included in the analytic sample for fidelity assessment. Fidelity was measured as coverage, content adherence and frequency of each core component, and the moderators assessed were implementation site and patient activation measure. RESULTS: Content adherence was high for three components with nearly 80.0% of patients setting ≥ 1 goal, having ≥ 1 PC visit and receiving ≥ 1 education session. Only 45.0% patients received ≥ 1 SDH referral. After adjusting for patient gender, language, race, ethnicity, and age, the implementation site moderated adherence to goal setting (77.4% BH vs. 87.7% VA), educational coaching (78.9% BH vs. 88.3% VA), number of successful CHW-patient encounters (6 BH vs 4 VA) and percent of patients receiving all four components (41.1% BH vs. 25.7% VA). CONCLUSIONS: The fidelity to the four CHORD intervention components differed between the two implementation sites, demonstrating the challenges in implementing complex evidence-based interventions in different settings. Our findings underscore the importance of measuring implementation fidelity in contextualizing the outcomes of randomized trials of complex multi-site behavioral interventions. TRIAL REGISTRATION: The trial was registered with ClinicalTrials.gov on 30/12/2016 and the registration number is NCT03006666 .

Policy by Pilot? Learning From Demonstration Projects for Integrated Care Comment on "Integration or Fragmentation of Health Care? Examining Policies and Politics in a Belgian Case Study".

Analysis of policy implementation for chronic disease in Belgium highlights the difficulties of launching experiments for integrated care in a health system with fragmented governance. It also entreats us to consider the inherent challenges of piloting integrated care for chronic disease. Sociomedical characteristics of chronic disease -political, social, and economic aspects of improving outcomes - pose distinct problems for pilot projects, particularly because addressing health inequity requires collaboration across health and social sectors and a long-term, life-course perspective on health. Drawing on recent US experience with demonstration projects for health service delivery reform and on chronic disease research, I discuss constraints of and lessons from pilot projects. The policy learning from pilots lies beyond their technical evaluative yield. Pilot projects can evince political and social challenges to achieving integrated chronic disease care, and can illuminate overlooked perspectives, such as those of community-based organizations (CBOs), thereby potentially extending the terms of policy debate.

Ensuring the ordinary: Politics and public service in municipal primary care in India.

This paper examines the political embeddedness of public-sector primary care in urban India. The low quality of urban healthcare in many low- and middle-income countries is well documented. But there is relatively little analysis showing how the politics of urban healthcare delivery contribute to quality shortfalls. This study integrates urban and political theory and draws on ethnographic fieldwork in municipal government-run primary care clinics in Pune, India. I conceptualize Pune's municipal doctors as street-level bureaucrats: frontline state agents charged with delivering public services, who regularly confront conflicts between their mandate and its realization in practice. I observe how the municipal doctors experience and respond to these conflicts; delineate the historical design of the municipal institutions in which they operate; and interview doctors, nurses, nonclinical staff, administrators, and elected officials, who collectively shape primary care delivery in municipal clinics. My findings show how the doctors' work is characterized by routine departures from public service ideals. The departures stem from local electoral politics (politicians' patronage and clientelistic relations with municipal employees and patients) and weak administrative capacity (misuse and incompetent planning of public resources). The doctors are compelled to follow extra-policy directives, meaning instructions that have little to do with healthcare goals and that emphasize the political utility rather than medical purpose of their work. In response, the doctors circumscribe their clinical practice. They aim, as one doctor put it, only to "ensure the ordinary," or to sustain a deficient status quo. In these conditions, improving quality of care requires not just behavioral interventions targeted at doctors. It requires normative, social, and organizational shifts in public service planning and delivery so that doctors are positioned - materially and affectively - to meet urban healthcare challenges in low-resource contexts.

Influence of organizational and social contexts on the implementation of culturally adapted hypertension control programs in Asian American-serving grocery stores, restaurants, and faith-based community sites: a qualitative study.

Hypertension affects a third of U.S. adults and is especially high among Asian American groups. The Racial and Ethnic Approaches to Community Health for Asian AmeRicans (REACH FAR) project delivers culturally adapted, evidence-based hypertension-related programs to Bangladeshi, Filipino, Korean, and Asian Indian communities in New York and New Jersey through 26 sites: ethnic grocery stores, restaurants, and Muslim, Christian, and Sikh faith-based organizations. Knowledge of the implementation mechanisms of culturally adapted programs is limited and is critical to inform the design and execution of such programs by and in community sites. We applied four categories of the Consolidated Framework for Implementation Research-intervention and individuals' characteristics, inner and outer setting-to analyze factors influencing implementation outcomes, that is, site leaders' perceptions about adopting, adapting, and sustaining REACH FAR. We conducted semistructured interviews with 15 leaders, coded them for implementation outcomes, and recoded them to identify contextual factors. Our findings show that REACH FAR resonated in sites where leaders perceived unhealthy diet and lifestyles in their communities (intervention characteristics), sites had historically engaged in health programs as a public-service mission (inner setting), and leaders identified with this mission (individuals' characteristics). Site leaders strived to adapt programs to respond to community preferences (outer setting) without compromising core objectives (inner setting). Leaders noted that program sustainability could be impeded by staff and volunteer turnover (inner setting) but enhanced by reinforcing programs through community networks (outer setting). The findings suggest that to facilitate implementation of culturally adapted health behavior programs through community sites, interventions should reinforce sites' organizational commitments and social ties.

Integrating Community Health Workers into Safety-Net Primary Care for Diabetes Prevention: Qualitative Analysis of Clinicians' Perspectives.

BACKGROUND: Evidence shows community health workers (CHWs) can effectively deliver proven behavior-change strategies to prevent type 2 diabetes mellitus (diabetes) and enhance preventive care efforts in primary care for minority and low-income populations. However, operational details to integrate CHWs into primary care practice remain less well known. OBJECTIVE: To examine clinicians' perceptions about working with CHWs for diabetes prevention in safety-net primary care. SETTING: Clinicians are primary care physicians and nurses at two New York City safety-net hospitals participating in CHORD (Community Health Outreach to Reduce Diabetes). CHORD is a cluster-randomized trial testing a CHW intervention to prevent diabetes. DESIGN: Guided by the Consolidated Framework for Implementation Research, we studied how features of the CHW model and organizational context of the primary care practices influenced clinicians' perspectives about the acceptability, appropriateness, and feasibility of a diabetes-prevention CHW program. Data were collected pre-intervention using semi-structured interviews (n = 18) and a 20-item survey (n = 54). APPROACH: Both survey and interview questions covered clinicians' perspectives on diabetes prevention, attitudes and beliefs about CHWs' role, expectations in working with CHWs, and use of clinic- and community-based diabetes- prevention resources. Survey responses were descriptively analyzed. Interviews were coded using a mix of deductive and inductive approaches for thematic analysis. KEY RESULTS: Eighty-seven percent of survey respondents agreed CHWs could help in preventing diabetes; 83% reported interest in working with CHWs. Ninety-one percent were aware of clinic-based prevention resources; only 11% were aware of community resources. Clinicians supported CHWs' cultural competency and neighborhood reach, but expressed concerns about the adequacy of CHWs' training; public and professional emphasis on diabetes treatment over prevention; and added workload and communication with CHWs. CONCLUSIONS: Clinicians found CHWs appropriate for diabetes prevention in safety-net settings. However, disseminating high-quality evidence about CHWs' effectiveness and operations is needed to overcome concerns about integrating CHWs in primary care.

Feasibility and Outcomes of an Electronic Health Record Intervention to Improve Hypertension Management in Immigrant-serving Primary Care Practices.

BACKGROUND: South Asians experience a disproportionate burden of high blood pressure (BP) in the United States, arguably the most preventable risk factor for cardiovascular disease. OBJECTIVE: We report 12-month results of an electronic health record (EHR)-based intervention, as a component of a larger project, "Implementing Million Hearts for Provider and Community Transformation." The EHR intervention included launching hypertension patient registries and implementing culturally tailored alerts and order sets to improve hypertension control among patients treated in 14 New York City practices located in predominantly South Asian immigrant neighborhoods. DESIGN: Using a modified stepped-wedge quasi-experimental study design, practice-level EHR data were extracted, and individual-level data were obtained on a subset of patients insured by a Medicaid insurer via their data warehouse. The primary aggregate outcome was change in proportion of hypertensive patients with controlled BP; individual-level outcomes included average systolic BP (SBP) and diastolic BP (DBP) at last clinic visit. Qualitative interviews were conducted to assess intervention feasibility. MEASURES: Hypertension was defined as having at least 1 hypertension ICD-9/10 code. Well-controlled hypertension was defined as SBP<140 and DBP<90 mm Hg. RESULTS: Postintervention, we observed a significant improvement in hypertension control at the practice level, adjusting for age and sex patient composition (adjusted relative risk, 1.09; 95% confidence interval, 1.04-1.14). Among the subset of Medicaid patients, we observed a significant reduction in average SBP and DBP adjusting for time, age, and sex, by 1.71 and 1.13 mm Hg, respectively (P<0.05). Providers reported feeling supported and satisfied with EHR components. CONCLUSIONS: EHR initiatives in practices serving immigrants and minorities may enhance practice capabilities to improve hypertension control.

Analysing power and politics in health policies and systems.

This special issue of Global Public Health presents a collection of articles that analyse power and its mechanisms in health systems and health policy processes. Researchers have long noted that the influence of power is implicated throughout the global health field, yet theories and methods for examining power-its sources, workings, and effects-are rarely applied in health policy and systems research. By engaging with the social sciences and humanities, contributors to this collection aim to analytically sharpen and thematically broaden the study of power and politics in global health. Contributors analyse the exercise of power by actors typically considered powerful on the global stage as well as actors across the health system who may be powerful in national or local contexts. Additionally, the papers draw attention to actors, interest groups, and practices not usually viewed as politically salient in health policy and systems research in low- and middle-income countries. The papers not only analyse power but also identify ways to counteract it, such as by using human rights-based frameworks to investigate and challenge power asymmetries. Collectively, they show how researchers working on global health issues can theorise power and deepen political analysis of health policy and systems.

The power of popular opinion in everyday primary care provision in urban India.

Studies of power in health care settings in low- and middle-income countries largely describe providers' exercise of discretionary power in frontline roles, leaving under-specified the macro-institutions and mechanisms of power that drive health care outcomes. In this study I conceptualise providers' actions not in terms of discretionary power but as obligatory responses to 'authority' over them. Authority denotes an actor's rightfully held social power over others, who accept to follow that actor's directives. Explaining authority's workings entails studying how it operates from its subjects' perspectives. I analyse in particular the authority of popular opinion-which derives from citizens' claims to state services-over primary care doctors in municipal health facilities in Pune, India. Through year-long ethnographic fieldwork, I examine doctors' experience of popular opinion, social relations between doctors and communities, and the institutional history of state-provided urban primary care. Findings show that doctors routinely confront popular disregard for their services. But under conditions of long-standing neglect of municipal services, tenuous state-society relations, and an avid, widely preferred private sector, doctors appear unable and wary to deliver more than minimum clinical care. Their circumscribed response reflects mechanisms by which the power of popular opinion, under policy neglect, impels them to maintain a deficient status quo.

Protocol for the CHORD project (community health outreach to reduce diabetes): a cluster-randomized community health worker trial to prevent diabetes.

BACKGROUND: Type 2 diabetes mellitus (DM) affects 9.4% of US adults and children, while another 33.9% of Americans are at risk of DM. Health care institutions face many barriers to systematically delivering the preventive care needed to decrease DM incidence. Community health workers (CHWs) may, as frontline public health workers bridging clinic and community, help overcome these challenges. This paper presents the protocol for a pragmatic, cluster-randomized trial integrating CHWs into two primary care clinics to support DM prevention for at-risk patients. METHODS: The trial will randomize 15 care teams, stratified by practice site (Bellevue Hospital and Manhattan VA), totaling 56 primary care physicians. The study cohort will consist of ~ 2000 patients who are 18-75 years of age, actively enrolled in a primary care team, able to speak English or Spanish, and have at least one glycosylated hemoglobin (HbA1c) result in the prediabetic range (5.7-6.4%) since 2012. Those with a current DM diagnosis or DM medication prescription (other than metformin) are ineligible. The intervention consists of four core activities - setting health goals, health education, activation for doctor's appointments, and referrals to DM prevention programs - adjustable according to the patient's needs and readiness. The primary outcome is DM incidence. Secondary outcomes include weight loss, HbA1C, and self-reported health behaviors. Clinical variables and health behaviors will be obtained through electronic medical records and surveys, respectively. Implementation outcomes, namely implementation fidelity and physicians' perspectives about CHW integration into the clinic, will be assessed using interviews and CHW activity logs and analyzed for the influence of moderating organizational factors. DISCUSSION: This is the first rigorous, pragmatic trial to test the effectiveness of integrating CHWs into primary care for DM prevention reaching a population-based sample. Our study's limitations include language-based eligibility and the use of HbA1c as a measure of DM risk. It will measure both clinical and implementation outcomes and potentially broaden the evidence base for CHWs and patient-centered medical home implementation. Further, the intervention's unique features, notably patient-level personalization and referral to existing programs, may offer a scalable model to benefit patients at-risk of DM. TRIAL REGISTRATION: Clinicaltrials.gov NCT03006666 (Received 12/27/2016).

Bringing the state back in: understanding and validating measures of governments' political commitment to HIV.

Analysis of the politics of HIV programme scale-up requires critical attention to the role of the state, since the state formulates HIV policies, provides resources for the HIV response and negotiates donor involvement in HIV programmes. However, conceptual and methodological approaches to analysing states' responses to HIV remain underdeveloped. Research suggests that differences in states' successes in HIV programme scale-up reflect their levels of 'political commitment' to responding to HIV. Few empirical measures of political commitment exist, and those that do, notably the AIDS Program Effort Index (API), employ ad hoc scoring approaches to combine information from different variables into an index of commitment. The indices are thus difficult to interpret and may not have empirically useful meaning. In this paper, we apply exploratory factor analysis to examine whether, and how, selected variables that comprise the API score reflect previously theorised dimensions of political commitment. We investigate how variables associated with each of the factors identified in the analyses correspond to these theorised dimensions as well as to API categories. Finally, we discuss potential uses--such as political benchmarking and accountability--and challenges of factor analysis as a means to identify and measure states' political commitment to respond to HIV.

Indicators of political commitment to respond to HIV.

OBJECTIVES: National political commitment is likely to become particularly crucial to sustaining antiretroviral treatment programmes in the coming decade, as donor contributions to HIV funding decreases. The objective of this study is to synthesise information on existing indicators of political commitment to respond to national HIV epidemics. METHODS: The authors describe and critically evaluate the existing indicators and propose studies to validate them. RESULTS: Several indicators have been developed to measure governments' political commitment to respond to national HIV epidemics--the AIDS Program Effort Index, the United Nations General Assembly Special Session on HIV/AIDS Declaration of Commitment Indicators and the AIDS Policy Aggressiveness Indicators--but the validity of these measures has not been systematically assessed. The indicators differ in their intended use, collection methods, content categories, data coverage, and strengths and limitations. Several types of studies could be used to test indicator validity (based on indicator content, comparisons of the same indicator using different elicitation methods, relationship patterns between indicators, relations between indicators and other variables and the consequences of using the indicators). CONCLUSIONS: The existing indicators of political commitment to respond to national HIV epidemics are useful for many purposes, including research, policymaking and advocacy. A range of studies could improve the understanding of indicator validity. New data collection and measurement approaches offer opportunities to improve how actors in the HIV community capture the complicated, multidimensional concept of political commitment.

Conceptual and methodological challenges to measuring political commitment to respond to HIV.

BACKGROUND: Researchers have long recognized the importance of a central government's political "commitment" in order to mount an effective response to HIV. The concept of political commitment remains ill-defined, however, and little guidance has been given on how to measure this construct and its relationship with HIV-related outcomes. Several countries have experienced declines in HIV infection rates, but conceptual difficulties arise in linking these declines to political commitment as opposed to underlying social and behavioural factors. METHODS: This paper first presents a critical review of the literature on existing efforts to conceptualize and measure political commitment to respond to HIV and the linkages between political commitment and HIV-related outcomes. Based on the elements identified in this review, the paper then develops and presents a framework to assist researchers in making choices about how to assess a government's level of political commitment to respond to HIV and how to link political commitment to HIV-related outcomes. RESULTS: The review of existing studies identifies three components of commitment (expressed, institutional and budgetary commitment) as different dimensions along which commitment can be measured. The review also identifies normative and ideological aspects of commitment and a set of variables that mediate and moderate political commitment that need to be accounted for in order to draw valid inferences about the relationship between political commitment and HIV-related outcomes. The framework summarizes a set of steps that researchers can follow in order to assess a government's level of commitment to respond to HIV and suggests ways to apply the framework to country cases. CONCLUSIONS: Whereas existing studies have adopted a limited and often ambiguous conception of political commitment, we argue that conceiving of political commitment along a greater number of dimensions will allow researchers to draw a more complete picture of political commitment to respond to HIV that avoids making invalid inferences about the relationship between political commitment and HIV outcomes.