PERSPECTIVE RISKS(AND BENEFITS)IN CER TRIALS ment of the risks and benefits of reflect consideration and com- proposed changes to US federal regulations he study as a whole. This ap- munication about these potential governing research: JAMA2012 307:589.90 proach often requires analysts to risks and benefits both separate- vices. Notice of a Department of Health and make judgments when compar- ly and as a whole. Human Services public meeting Fed Regist ng one sort of risk to another. Disclosure forms provided by the authors 013:78(123):38343-5(http://www.gpo.gov/ The communication of informa- are available with the full text of this article fdsys/pkg/FR-2013-06-26/pdf/2013-15160 tion on these various forms of at NEJM. org 3. Feudtner C. Ethics in the midst of thera risks and benefits to potential From the ment of medical Ethics utic evolution. Arch pediatr Adolesc med 2008:1628547 study participants requires a bal- (C F)and the committees for the Protec. 4. Vist GE, Bryant D, somerville L, B ancing act. Detailed explanation of dren's Hospital of Philadelphia, Philadel. hem T, Oxman AD. Outcomes of( each separate risk may be over- phia; and the Children's Mercy Bioethics who participate in randomized whelming and confusing. Sum- Center, Children's Mercy Hospital, Kansa atients rec similar interventions who do not partic maries of the risks may ove ersi- hrane Database Syst Rev 2008 3 risks. 5 Evaluation of the accept. 20us article was published on August 21, 5. Schreiner MS. Can we keep it simple plify or underemphasize particular Th ability of studies and of the ad 1. Kass N, Faden R, Tunis S Addressing low. DOL: 10.1056/NEJMp1309322 equacy of consent forms must risk comparative effectiveness research in Copright o 2013 Massachusetts Medical Society Community Health Workers-A Local Solution to a global Problem Prabhjot Singh, M.D., Ph. D, and Dave A Chokshi, M D n the face of persistently lack- United States could improve health advocates, social activists, health luster job creation, the U.S. outcomes, reduce health care promoters, and patient navigators, health sector is paradoxically costs, and create jobs among other roles. In California seen as both a contributor to tor- In many countries, CHWs are and other border states, promotoras id macroeconomic growth and becoming paid, full-time members and promotors de salud address re- a source of local employment op- of community health systems. In productive health, diabetes, ar portunities. Labor costs account sub-Saharan Africa, the One Mil- cardiovascular health. In Arkan- for more than half of U.S. health lion Community Health Workers sas, CHWs have been shown care spending, but as payment Campaign is training, deploying, reduce Medicaid spending by structures shift from volume- and integrating CHWs into the reaching out to people with long- based reimbursement to the re- health system. 1 In India, 600,000 term care needs; in Alaska, they're warding of value in improving CHWs are paid through a fee-for- part of an effective primary care health, the locus of health care service system to perform a spe- extension system. multiple states delivery will expand from facili- cific set of primary care func- have created formal accreditation ties to communities. Ideally, pa- tions, such as immunization. In programs for CHWs, and in 2009, tient care will take place not just Brazil, community health agents the Department of Labor recog- in episodic encounters but also are part of family health teams nized CHWs' jobs as a distinct through continuous, community- that now care for 110 million category of employment. Yet de- based partnerships that include people And growing evidence re- spite these gains and in part new entities and workers. Else- veals the effectiveness of inter- because of the organic way in where in the world, such care ventions by CHWs in multiple which CHWs have emerged has involved the use of commu- health arenas, such as maternal there is little standardization nity health workers(CHWs)- and child health and chronic- across health systems in terms of ay community members with disease management.2 gaining access to CHWS, integrat focused health care training. We CHWs have been part of the ing them into health care pro- believe that scaling up the com- U.S. health care landscape for cesses, and compensating them. munity health workforce in the decades, serving as communi There are three models for N ENGL J MED 369; 10 NEJM.ORG SEPTEMBER 5, 2013
PERSPECTIVE 894 n engl j med 369;10 nejm.org september 5, 2013 Risks (and Benefits) in CER Trials Community Health Workers — A Local Solution to a Global Problem Prabhjot Singh, M.D., Ph.D., and Dave A. Chokshi, M.D. I n the face of persistently lackluster job creation, the U.S. health sector is paradoxically seen as both a contributor to torpid macroeconomic growth and a source of local employment opportunities. Labor costs account for more than half of U.S. health care spending, but as payment structures shift from volumebased reimbursement to the rewarding of value in improving health, the locus of health care delivery will expand from facilities to communities. Ideally, patient care will take place not just in episodic encounters but also through continuous, communitybased partnerships that include new entities and workers. Elsewhere in the world, such care has involved the use of community health workers (CHWs) — lay community members with focused health care training. We believe that scaling up the community health workforce in the United States could improve health outcomes, reduce health care costs, and create jobs. In many countries, CHWs are becoming paid, full-time members of community health systems. In sub-Saharan Africa, the One Million Community Health Workers Campaign is training, deploying, and integrating CHWs into the health system.1 In India, 600,000 CHWs are paid through a fee-forservice system to perform a specific set of primary care functions, such as immunization. In Brazil, community health agents are part of family health teams that now care for 110 million people. And growing evidence reveals the effectiveness of interventions by CHWs in multiple health arenas, such as maternal and child health and chronicdisease management.2 CHWs have been part of the U.S. health care landscape for decades, serving as community advocates, social activists, health promoters, and patient navigators, among other roles. In California and other border states, promotoras and promotores de salud address reproductive health, diabetes, and cardiovascular health. In Arkansas, CHWs have been shown to reduce Medicaid spending by reaching out to people with longterm care needs; in Alaska, they’re part of an effective primary care extension system. Multiple states have created formal accreditation programs for CHWs, and in 2009, the Department of Labor recognized CHWs’ jobs as a distinct category of employment. Yet despite these gains — and in part because of the organic way in which CHWs have emerged — there is little standardization across health systems in terms of gaining access to CHWs, integrating them into health care processes, and compensating them. There are three models for orment of the risks and benefits of the study as a whole. This approach often requires analysts to make judgments when comparing one sort of risk to another. The communication of information on these various forms of risks and benefits to potential study participants requires a balancing act. Detailed explanation of each separate risk may be overwhelming and confusing. Summaries of the risks may oversimplify or underemphasize particular risks.5 Evaluation of the acceptability of studies and of the adequacy of consent forms must reflect consideration and communication about these potential risks and benefits both separately and as a whole. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. From the Department of Medical Ethics (C.F.) and the Committees for the Protection of Human Subjects (M.S.), the Children’s Hospital of Philadelphia, Philadelphia; and the Children’s Mercy Bioethics Center, Children’s Mercy Hospital, Kansas City, MO (J.D.L.). This article was published on August 21, 2013, at NEJM.org. 1. Kass N, Faden R, Tunis S. Addressing lowrisk comparative effectiveness research in proposed changes to US federal regulations governing research. JAMA 2012;307:1589-90. 2. Department of Health and Human Services. Notice of a Department of Health and Human Services public meeting. Fed Regist 2013;78(123):38343-5 (http://www.gpo.gov/ fdsys/pkg/FR-2013-06-26/pdf/2013-15160 .pdf). 3. Feudtner C. Ethics in the midst of therapeutic evolution. Arch Pediatr Adolesc Med 2008;162:854-7. 4. Vist GE, Bryant D, Somerville L, Birminghem T, Oxman AD. Outcomes of patients who participate in randomized controlled trials compared to similar patients receiving similar interventions who do not participate. Cochrane Database Syst Rev 2008;3: MR000009. 5. Schreiner MS. Can we keep it simple? JAMA Pediatr 2013;167:603-5. DOI: 10.1056/NEJMp1309322 Copyright © 2013 Massachusetts Medical Society
PERSPECTIVE COMMUNITY HEALTH WORKERS Models for Organizing Community Health Workers(CHWs)in the United States. Extensions of hospital or clinic systems, with health care system New york (WIN) for Asthma Program, New York: CHWs serve as the single gement or care teams and are focused on clinical point of contact for families; in clinics, the hospital, and the community, services they provide asthma education, support, and referrals for social services. Community-based nonprofit organizations, rooted in commu ess. Oran CA: CHWs educate their ganizations often provide a of ost of other services for the community, both health-related tal health, domestic violence, parenting, and access to and non-health-related “ entities, organizations dedicated to CHWs that are City Health Works, New York: A close-to client network of CHWs whe t support financial sustainability, population and environmental in community settings, and primary care coordination for chronic goals, and local workforce dev conditions ganizing U.S. CHWs: employment when delivered by more exten- often fragmented CHWs who can of CHWs as extensions of hospi- sively trained health care workers integrate knowledge of the local tal systems, management of CHWs and that are difficult to coordi- social service milieu with knowl- through community-based non- nate in community settings. edge of patients'individual cir profit organizations, and man- The Affordable Care Act(ACA) cumstances can create a vital link agement of CHWs by entities that includes levers to shift our health for vulnerable populations. In con operate at the interface between care systems focus toward com- cert with social workers, CHWs health systems and the commu- prehensive, high-quality care for can mobilize social support, cre- nity(see table). The first two ap- populations. Through structures ate avenues for family members proaches reflect CHWs' historical such as accountable care organi- to engage in the care process, roles-as a means for broaden- zations and incentives such as and strengthen long-term commu ing the health care system's reach readmissions penalties, hospitals nity relationships that help pa- and as community activists and are increasingly responsible for tients sustain healthful behaviors health educators. The third ap- the care of patients both in and There's also an economic ra proach aims to synthesize these outside the hospital. For example, tonale for considering CHW pro- roles while borrowing principles hospital systems have invested in grams. Employment of CHWs from global experiences with care coordinators, aiming to re- creates meaningful job growth scalability and opportunities for duce readmission rates by strati- for people with lower educational financial sustainability. For exam- fying patients according to risk attainment (passage of the Gen ple, the Prevention and Access to level and tailoring their discharge eral Educational Development are and Treatment(PACT) proj- interventions. As these systems [GED] or higher tests)-often ct drew from the nonprofit or- look further beyond their own in low-income communities that ganization Partners in Health in walls, they may see opportunities have been hardest hit by the eco- integrating CHWs into a care- for lower-cost, CHW-based pro- nomic downturn-and particu- management program for patients grams to demonstrate superior larly for women. From the per- in boston who have Hiv-alds. value. 3 spective of a health system, CHW The PACT model was subsequent yond reducing read be a bargain, with mean an- ly expanded to cover patients with CHW programs may help to ad- nual pay of about $37,000 in diabetes or other chronic condi- dress the root causes of prevent- 2012. Further research is needed tions. More generally, organiza- able chronic disease. Social ex to assess the cost-effectiveness of tions dedicated to CHWs could clusion, poverty, marginalization, interventions by CHWs, but pilot support health systems by re- and the built environment con- programs have shown both re cruiting, training, and supervising tribute to the high burden of ductions in spending for Medi- CHWs. Longitudinally developed chronic disease, particularly in care and Medicaid populations expertise in CHW management low-income communities. But so- and clinical improvements in allows such organizations to pro- cial services addressing these so- areas such as medication adhe vide interventions that are costly cial determinants of health are too ence and glycemic control N ENGL J MED 369: 10 NEJM.ORG
n engl j med 369;10 nejm.org september 5, 2013 PERSPECTIVE 895 community health workers ganizing U.S. CHWs: employment of CHWs as extensions of hospital systems, management of CHWs through community-based nonprofit organizations, and management of CHWs by entities that operate at the interface between health systems and the community (see table). The first two approaches reflect CHWs’ historical roles — as a means for broadening the health care system’s reach and as community activists and health educators. The third approach aims to synthesize these roles while borrowing principles from global experiences with scalability and opportunities for financial sustainability. For example, the Prevention and Access to Care and Treatment (PACT) project drew from the nonprofit organization Partners in Health in integrating CHWs into a caremanagement program for patients in Boston who have HIV–AIDS. The PACT model was subsequently expanded to cover patients with diabetes or other chronic conditions. More generally, organizations dedicated to CHWs could support health systems by recruiting, training, and supervising CHWs. Longitudinally developed expertise in CHW management allows such organizations to provide interventions that are costly when delivered by more extensively trained health care workers and that are difficult to coordinate in community settings. The Affordable Care Act (ACA) includes levers to shift our health care system’s focus toward comprehensive, high-quality care for populations. Through structures such as accountable care organizations and incentives such as readmissions penalties, hospitals are increasingly responsible for the care of patients both in and outside the hospital. For example, hospital systems have invested in care coordinators, aiming to reduce readmission rates by stratifying patients according to risk level and tailoring their discharge interventions. As these systems look further beyond their own walls, they may see opportunities for lower-cost, CHW-based programs to demonstrate superior value.3 Beyond reducing readmissions, CHW programs may help to address the root causes of preventable chronic disease. Social exclusion, poverty, marginalization, and the built environment contribute to the high burden of chronic disease, particularly in low-income communities. But social services addressing these social determinants of health are too often fragmented. CHWs who can integrate knowledge of the local social service milieu with knowledge of patients’ individual circumstances can create a vital link for vulnerable populations. In concert with social workers, CHWs can mobilize social support, create avenues for family members to engage in the care process, and strengthen long-term community relationships that help patients sustain healthful behaviors. There’s also an economic rationale for considering CHW programs. Employment of CHWs creates meaningful job growth for people with lower educational attainment (passage of the General Educational Development [GED] or higher tests) — often in low-income communities that have been hardest hit by the economic downturn — and particularly for women. From the perspective of a health system, CHWs may be a bargain, with mean annual pay of about $37,000 in 2012. Further research is needed to assess the cost-effectiveness of interventions by CHWs, but pilot programs have shown both reductions in spending for Medicare and Medicaid populations and clinical improvements in areas such as medication adherence and glycemic control. Models for Organizing Community Health Workers (CHWs) in the United States. Model Example Extensions of hospital or clinic systems, with health care system as base of operations; CHWs are integrated with diseasemanagement or care teams and are focused on clinical services. New York–Presbyterian Hospital Washington Heights/Inwood Network (WIN) for Asthma Program, New York: CHWs serve as the single point of contact for families; in clinics, the hospital, and the community, they provide asthma education, support, and referrals for social services. Community-based nonprofit organizations, rooted in community mobilization, activism, or faith; organizations often provide a host of other services for the community, both health-related and non–health-related. Latino Health Access, Orange County, CA: CHWs educate their neighbors about a broad range of social and health issues, including nutrition, diabetes, mental health, domestic violence, parenting, and access to health care. Management entities, organizations dedicated to CHWs that are integrated with clinical and community organizations; oriented around financial sustainability, population and environmental health goals, and local workforce development. City Health Works, New York: A close-to-client network of CHWs who perform protocol-driven early risk detection, self-management support in community settings, and primary care coordination for chronic conditions
PERSPECTIVE o further develop the prom- approach to CHw certification as the strong network of commu- ise of CHWs, policymakers and across states. Certification helps nity health centers, could facili- health system leaders could take to professionalize the community tate CHW integration into the five initial steps. First, the evi- health workforce, driving quality health system. The timing for in- dence base for CHW programs standards for training and per- vestment in CHWs is also pro should be shored up, through formance. The experience that pitious, given the post-ACA land both additional, pragmatic clini- Massachusetts had with policy de- scape and the potential for cal studies and consensus assess- velopment toward its 2010 CHW- meaningful job creation. Although ment of completed research. The certification law may hold lessons the operational challenges of Community Preventive Services for a national effort.5 CHW integration are manifold Task Force could perform the evi- Fourth, the Sl billion second the global experience offers hope dence assessment, building on the round of Health Care Innovation for U.S. communities. 2007 Community Health Worker Awards from the Innovation Cen- National Workforce Study, Addi- ter of the Centers for Medicare anE/M.org vailable with the full text of this article examining disease-specific, single- could include a focus on CHW- From the School of International and Public ses of CHW integration into prl- vations had beneficial effects on sity, and eth Institute, Columbia Univer- site pilots to larger-scale analy- based interventions. If such inno- Affairs and E Mount Sinai Hospital both in New York tary care, drawing from global population health and cost, CMS (P.S. ) and the Department of Veterans Af research paradigms. 4 could consider payment schemes fairs, Washington, DC(. A.C.) Second, policymakers could ad- to more broadly support CHW 1. Singh P. Sachs JD. 1 Million dress continued stagnation in job programs- for example, as part health workers in sub-Saharan Africa by 2015 growth by promoting CHWs as a of Medicaid case management. Lancet 2013: 382: 363-5 linchpin for health system re- Fifth, dedicated community Global experience of community healt structuring. Indeed, Section 5313 health workforce organizations workers for delivery of health related Millen of the aca was dedicated to could collaborate with insurance nium Development Goals: a systematic re- grants for underserved commu- companies and hospitals to mea- view, country case studies, and recommen- nities to employ CHWs -but sure return on investment and ystems. Geneva: World Health O was left unfunded. Revisiting this refine clinical protocols that sup- tion, 2010 possibility could be productive, port CHWs, as well as informa 3.KangoviS,LongJa,EmanuelE.commU- since the federal government is tion technology linking patients, Arch Intern 4. Victora CG, Black RE, Boerma JT, Bryce ng and training of ACA"naviga- The most crucial lesson from Measuring m pact in th e Mitenn ium D rs”to lobal CH that th to large-scale effectiveness evalua- new health insurance exchanges. community rootedness of CHWs tions. Lancet 201137785 isting CHWs might be a natu- should be retained through care- Martin CM, Fox D), Hirsch( ral fit for this role- and newly ful, representative selection and change to promote communit trained ACA navigators might by ensuring that CHWs spend ers: lessons from Massachu consider becoming CHWs. most of their time in the com- health reform era. Am J Public Health 2011 Third, the Department of La- munity. In the United States, cer- Do: 10.1056/NEJMp1305636 bor could support a harmonized tain structural advantages, such Copyright o 2013 Massachusetts Medical Society Big Pharma and Social Responsibility-The access to medicine index Hans V. Hogerzeil, M.D., Ph.D. espite much progress in the medicines. 1 Many of the most widening gaps between rapidly of t sast decade, about one third neglected people live in sub-Saha- growing middle classes and poor e world's population still has ran Africa, but another billion live people who live on less than a 10 regular access to essential in emerging economies that have dollar a day. 2 Such people face N ENGL J MED 369; 10 NEJM.ORG SEPTEMBER 5, 2013
PERSPECTIVE 896 n engl j med 369;10 nejm.org september 5, 2013 To further develop the promise of CHWs, policymakers and health system leaders could take five initial steps. First, the evidence base for CHW programs should be shored up, through both additional, pragmatic clinical studies and consensus assessment of completed research. The Community Preventive Services Task Force could perform the evidence assessment, building on the 2007 Community Health Worker National Workforce Study. Additional studies should move beyond examining disease-specific, singlesite pilots to larger-scale analyses of CHW integration into primary care, drawing from global research paradigms.4 Second, policymakers could address continued stagnation in job growth by promoting CHWs as a linchpin for health system restructuring. Indeed, Section 5313 of the ACA was dedicated to grants for underserved communities to employ CHWs — but was left unfunded. Revisiting this possibility could be productive, since the federal government is investing $67 million in the hiring and training of ACA “navigators” to help consumers with the new health insurance exchanges. Existing CHWs might be a natural fit for this role — and newly trained ACA navigators might consider becoming CHWs. Third, the Department of Labor could support a harmonized approach to CHW certification across states. Certification helps to professionalize the community health workforce, driving quality standards for training and performance. The experience that Massachusetts had with policy development toward its 2010 CHWcertification law may hold lessons for a national effort.5 Fourth, the $1 billion second round of Health Care Innovation Awards from the Innovation Center of the Centers for Medicare and Medicaid Services (CMS) could include a focus on CHWbased interventions. If such innovations had beneficial effects on population health and cost, CMS could consider payment schemes to more broadly support CHW programs — for example, as part of Medicaid case management. Fifth, dedicated community health workforce organizations could collaborate with insurance companies and hospitals to measure return on investment and to refine clinical protocols that support CHWs, as well as information technology linking patients, CHWs, and providers. The most crucial lesson from global CHW programs is that the community rootedness of CHWs should be retained through careful, representative selection and by ensuring that CHWs spend most of their time in the community. In the United States, certain structural advantages, such as the strong network of community health centers, could facilitate CHW integration into the health system. The timing for investment in CHWs is also propitious, given the post-ACA landscape and the potential for meaningful job creation. Although the operational challenges of CHW integration are manifold, the global experience offers hope for U.S. communities. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. From the School of International and Public Affairs and Earth Institute, Columbia University; and the Department of Medicine, Mount Sinai Hospital — both in New York (P.S.); and the Department of Veterans Affairs, Washington, DC (D.A.C.). 1. Singh P, Sachs JD. 1 Million community health workers in sub-Saharan Africa by 2015. Lancet 2013;382:363-5. 2. Bhutta Z, Lassi Z, Pariyo G, Huicho L. Global experience of community health workers for delivery of health related Millennium Development Goals: a systematic review, country case studies, and recommendations for integration into national health systems. Geneva: World Health Organization, 2010. 3. Kangovi S, Long JA, Emanuel E. Community health workers combat readmission. Arch Intern Med 2012;172:1756-7. 4. Victora CG, Black RE, Boerma JT, Bryce J. Measuring impact in the Millennium Development Goal era and beyond: a new approach to large-scale effectiveness evaluations. Lancet 2011;377:85-95. 5. Mason T, Wilkinson GW, Nannini A, Martin CM, Fox DJ, Hirsch G. Winning policy change to promote community health workers: lessons from Massachusetts in the health reform era. Am J Public Health 2011; 101:2211-6. DOI: 10.1056/NEJMp1305636 Copyright © 2013 Massachusetts Medical Society. community health workers Big Pharma and Social Responsibility — The Access to Medicine Index Hans V. Hogerzeil, M.D., Ph.D. Despite much progress in the past decade, about one third of the world’s population still has no regular access to essential medicines.1 Many of the most neglected people live in sub-Saharan Africa, but another billion live in emerging economies that have widening gaps between rapidly growing middle classes and poor people who live on less than a dollar a day.2 Such people face