Study protocol of EMPOWER participatory action research (EMPOWER-PAR): a pragmatic cluster randomised controlled trial of multifaceted chronic disease management strategies to improve diabetes and hypertension outcomes in primary care

Anis S Ramli, Sharmila Lakshmanan, Jamaiyah Haniff, Sharmini Selvarajah, Seng F Tong, Mohamad-Adam Bujang, Suraya Abdul-Razak, Asrul A Shafie, Verna K M Lee, Thuhairah H Abdul-Rahman, Maryam H Daud, Kien K Ng, Farnaza Ariffin, Hasidah Abdul-Hamid, Md-Yasin Mazapuspavina, Nafiza Mat-Nasir, Maizatullifah Miskan, Jaya P Stanley-Ponniah, Mastura Ismail, Chun W Chan, Yong R Abdul-Rahman, Boon-How Chew, Wilson H H Low, Anis S Ramli, Sharmila Lakshmanan, Jamaiyah Haniff, Sharmini Selvarajah, Seng F Tong, Mohamad-Adam Bujang, Suraya Abdul-Razak, Asrul A Shafie, Verna K M Lee, Thuhairah H Abdul-Rahman, Maryam H Daud, Kien K Ng, Farnaza Ariffin, Hasidah Abdul-Hamid, Md-Yasin Mazapuspavina, Nafiza Mat-Nasir, Maizatullifah Miskan, Jaya P Stanley-Ponniah, Mastura Ismail, Chun W Chan, Yong R Abdul-Rahman, Boon-How Chew, Wilson H H Low

Abstract

Background: Chronic disease management presents enormous challenges to the primary care workforce because of the rising epidemic of cardiovascular risk factors. The chronic care model was proven effective in improving chronic disease outcomes in developed countries, but there is little evidence of its effectiveness in developing countries. The aim of this study was to evaluate the effectiveness of the EMPOWER-PAR intervention (multifaceted chronic disease management strategies based on the chronic care model) in improving outcomes for type 2 diabetes mellitus and hypertension using readily available resources in the Malaysian public primary care setting. This paper presents the study protocol.

Methods/design: A pragmatic cluster randomised controlled trial using participatory action research is underway in 10 public primary care clinics in Selangor and Kuala Lumpur, Malaysia. Five clinics were randomly selected to provide the EMPOWER-PAR intervention for 1 year and another five clinics continued with usual care. Each clinic consecutively recruits type 2 diabetes mellitus and hypertension patients fulfilling the inclusion and exclusion criteria over a 2-week period. The EMPOWER-PAR intervention consists of creating/strengthening a multidisciplinary chronic disease management team, training the team to use the Global Cardiovascular Risks Self-Management Booklet to support patient care and reinforcing the use of relevant clinical practice guidelines for management and prescribing. For type 2 diabetes mellitus, the primary outcome is the change in the proportion of patients achieving HbA1c < 6.5%. For hypertension without type 2 diabetes mellitus, the primary outcome is the change in the proportion of patients achieving blood pressure < 140/90 mmHg. Secondary outcomes include the proportion of patients achieving targets for serum lipid profile, body mass index and waist circumference. Other outcome measures include medication adherence levels, process of care and prescribing patterns. Patients' assessment of their chronic disease care and providers' perceptions, attitudes and perceived barriers in care delivery and cost-effectiveness of the intervention are also evaluated.

Discussion: Results from this study will provide objective evidence of the effectiveness and cost-effectiveness of a multifaceted intervention based on the chronic care model in resource-constrained public primary care settings. The evidence should instigate crucial primary care system change in Malaysia.

Trial registration: ClinicalTrials.gov NCT01545401.

Figures

Figure 1
Figure 1
EMPOWER-PAR Trial Profile: Enrolment of Public Primary Care Clinics and Recruitment of Patients.

References

    1. Ueshima H, Sekikawa A, Miura K, Turin TC, Takashima N, Kita Y, Watanabe M, Kadota A, Okuda N, Kadowaki T, Nakamura Y, Okamura T. Cardiovascular disease and risk factors in Asia: a selected review. Circulation. 2008;118:2702–2709. doi: 10.1161/CIRCULATIONAHA.108.790048.
    1. Yach D, Hawkes C, Gould CL, Hofman KJ. The global burden of chronic diseases: overcoming impediments to prevention and control. JAMA. 2004;291(21):2616–2622. doi: 10.1001/jama.291.21.2616.
    1. World Health Organization . Preventing chronic diseases: a vital investment [online] 2005.
    1. Yusoff AF, Kaur G, Omar MA, Mustafa AN. Malaysian Burden of Disease and Injury Study. 2005.
    1. World Health Organisation . The impact of chronic disease in Malaysia [online] 2005.
    1. Clinical Research Centre, Ministry of Health, Malaysia . Annual Report of the NCVD-ACS Registry 2009-2010. 2013.
    1. Institute for Public Health, Ministry of Health, Malaysia . National Health and Morbidity Survey 2011 (NHMS 2011) vol II: Non-Communicable Disease. 2011.
    1. Clinical Research Centre, Ministry of Health, Malaysia . National Healthcare Establishments and Workforce Statistics (Primary Care) 2008–2009. 2011.
    1. Ramli AS, Taher SW. Managing chronic diseases in the Malaysian primary health care – a need for change. Malaysian Family Physician. 2008;3(1):7–13.
    1. Mimi O, Tong SF, Nordin S, Teng CL, Khoo EM, Abdul-Rahman A, Zailinawati AH, Lee VKM, Chen WS, Shihabudin WM, Noridah MS, Fauziah ZE. A comparison of morbidity patterns in public and private primary care clinics in Malaysia. Malaysian Family Physician. 2011;6(1):19–25.
    1. Mastura I, Chew BH, Lee PY, Cheong AT, Sazlina SG, Jamaiyah H, Syed Alwi SAR, Sri Wahyu T, Zaiton A. Control and treatment profiles of 70,889 adult Type 2 Diabetes Mellitus patients in Malaysia - a cross sectional survey in 2009. International Journal of Collaborative Research on Internal Medicine & Public Health. 2011;3:98–113.
    1. Cheong AT, Tong SF, Sazlina SG, Azah AS, Salmiah MS. Asia Pac J Public Health. 2013. Blood pressure control among hypertensive patients with and without diabetes mellitus in six public primary care clinics in Malaysia.
    1. Tong SF, Khoo EM, Nordin S, Teng CL, Lee VK, Zailinawati AH, Chen WS, Mimi O. Process of care and prescribing practices for hypertension in public and private primary care clinics in Malaysia. Asia Pac J Public Health. 2012;24:764–775. doi: 10.1177/1010539511402190.
    1. Wong JS, Tan F, Lee PY. The state of lipid control in patients with diabetes in a public health centre. Asia Pac J Public Health. 2007;19(3):16–21. doi: 10.1177/101053950701900304.
    1. Adeyi O, Smith O, Robles S. Public policy and the challenge of chronic non communicable diseases. Washington DC: World Bank; 2007.
    1. World Health Organisation . Innovative care for chronic conditions: building blocks for action. 2002.
    1. Beaglehole R, Epping-Jordan J, Patel V, Chopra M, Ebrahim S, Kidd M, Haines A. Improving the prevention and management of chronic disease in low-income and middle-income countries: a priority for primary health care. Lancet. 2008;372(9642):940–949. doi: 10.1016/S0140-6736(08)61404-X.
    1. Non-Communicable Disease Section, Disease Control Division, Ministry of Health Malaysia . National Strategic Plan for Non-Communicable Disease (NSPNCD): medium term strategic plan to further strengthen the cardiovascular diseases and diabetes prevention and control program in Malaysia (2010–2014) 2010.
    1. Samb B, Desai N, Nishtar S, Mendis S, Bekedam H, Wright A, Hsu J, Etienne C. Prevention and management of chronic disease: a litmus test for health-systems strengthening in low-income and middle-income countries. Lancet. 2010;376(9754):1785–1797. doi: 10.1016/S0140-6736(10)61353-0.
    1. World Health Organisation . Integrated management of cardiovascular risk: report of a WHO meeting. 2002.
    1. Wagner EH, Glasgow RE, Davis C, Bonomi AE, Provost L, McCulloch D, Carver P, Sixta C. Quality improvement in chronic illness care: a collaborative approach. Jt Comm J Qual Improv. 2001;27:63–80.
    1. Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for patients with chronic illness. JAMA. 2002;288(14):1775–1779. doi: 10.1001/jama.288.14.1775.
    1. Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for patients with chronic illness: the chronic care model, Part 2. JAMA. 2002;288(15):1909–1914. doi: 10.1001/jama.288.15.1909.
    1. Pearson ML, Wu S, Schaefer J, Bonomi AE, Shortell SM, Mendel PJ, Marsteller JA, Louis TA, Rosen M, Keeler EB. Assessing the implementation of the chronic care model in quality improvement collaboratives. Health Serv Res. 2005;40(4):978–996. doi: 10.1111/j.1475-6773.2005.00397.x.
    1. Baum F, MacDougall C, Smith D. Participatory action research. J Epidemiol Community Health. 2006;60:854–857. doi: 10.1136/jech.2004.028662.
    1. Zwar N, Harris M, Griffiths R, Roland M, Dennis S, Davies GP, Hasan I. A systematic review of chronic disease management. Research Centre for Primary Health Care and Equity: School of Public Health and Community Medicine, UNSW; 2006.
    1. Minkman M, Ahaus K, Huijsman R. Performance improvement based on integrated quality management models: what evidence do we have? A systematic literature review. Int J Qual Health Care. 2007;19(2):90–104. doi: 10.1093/intqhc/mzl071.
    1. Stellefson M, Dipnarine K, Stopka C. The chronic care model and diabetes management in US primary care settings: a systematic review. Prev Chronic Dis. 2013;10:120180. doi: 10.5888/pcd10.120180.
    1. Nolte E, Knai C, McKee M. Managing chronic conditions: experience in eight countries. European Observatory on Health Systems and Policies: World Health Organization; 2008.
    1. Dennis SM, Zwar N, Griffiths R, Roland M, Hasan I, Powell Davies G, Harris M. Chronic disease management in primary care: from evidence to policy. Med J Aust. 2008;188(8 Suppl):S53–S56.
    1. Ham C. Chronic care in the English National Health Service: progress and challenges. Health Aff. 2009;28(1):190–201. doi: 10.1377/hlthaff.28.1.190.
    1. Huang ES, Brown SES, Zhang JX, Kirchhoff AC, Schaefer CT, Casalino LP, Chin MH. The cost consequences of improving diabetes care: The Community Health Center Experience. Jt Comm J Qual Patient Saf. 2008;34(3):138–146.
    1. Huang ES, Zhang Q, Brown SES, Drum ML, Meltzer DO, Chin MH. The cost-effectiveness of improving diabetes care in U.S. federally qualified community health centers. Health Serv Res. 2007;42(6 Pt 1):2174–2193. doi: 10.1111/j.1475-6773.2007.00734.x.
    1. Nuño R, Coleman K, Bengoa R, Sauto R. Integrated care for chronic conditions: the contribution of the ICCC Framework. Health Policy. 2012;105(1):55–64. doi: 10.1016/j.healthpol.2011.10.006.
    1. Low WHH, Seet W, Ramli AS, Ng KK, Jamaiyah H, Dan SP, Teng CL, Lee VKM, Chua SS, Faridah Aryani MY, Karupaiah T, Chee WSS, Goh PP, Zaki M, Lim TO, CORFIS Study Group Community-based cardiovascular Risk Factors Intervention Strategies (CORFIS) in managing hypertension: A pragmatic non-randomised controlled trial. Med J Malaysia. 2013;68(2):129–135.
    1. Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D, CONSORT group; Pragmatic Trials in Healthcare (Practihc) group Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008;337:a2390. doi: 10.1136/bmj.a2390.
    1. Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010;8:18. doi: 10.1186/1741-7015-8-18.
    1. Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869. doi: 10.1136/bmj.c869.
    1. Godwin M, Ruhland L, Casson I, MacDonald S, Delva D, Birtwhistle R, Lam M, Seguin R. Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity. BMC Medical Res Methodol. 2003;3:28. doi: 10.1186/1471-2288-3-28.
    1. Lingard L, Albert M, Levinson W. Grounded theory, mixed methods, and actionresearch. BMJ. 2008;337:567. doi: 10.1136/bmj.39602.690162.47.
    1. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655. doi: 10.1136/bmj.a1655.
    1. Health Technology Assessment Section, Medical Development Division, Ministry of Health, Malaysia . Clinical Practice Guideline on the Management of Type 2 Diabetes Mellitus. 4 2009.
    1. Health Technology Assessment Section, Medical Development Division, Ministry of Health, Malaysia . Clinical Practice Guidelines on the Management of Hypertension. 3 2008.
    1. Coleman K, Austin BT, Brach C, Wagner EH. Evidence on the chronic care model in the new millennium. Health Aff. 2009;28(1):75–85. doi: 10.1377/hlthaff.28.1.75.
    1. Tsai AC, Morton SC, Mangione CM, Keeler EB. A meta-analysis of interventions to improve care for chronic illnesses. Am J Manag Care. 2005;11(8):478–488.
    1. Epping-Jordan JE, Pruitt SD, Bengoa R, Wagner EH. Improving the quality of health care for chronic conditions. Qual Saf Health Care. 2004;13(4):299–305. doi: 10.1136/qshc.2004.010744.
    1. Fleming B, Silver A, Ocepek-Welikson K, Keller D. The relationship between organizational systems and clinical quality in diabetes care. Am J Manag Care. 2004;10(12):934–944.
    1. Sperl-Hillen JM. Do all components of the chronic care model contribute equally to quality improvement? Jt Comm J Qual Saf. 2004;30(6):303–309.
    1. Grimshaw JM, Thomas RE, MacLennan G, Fraser C, Ramsay CR, Vale L, Whitty P, Eccles MP, Matowe L, Shirran L, Wensing M, Dijkstra R, Donaldson C. Effectiveness and efficiency of guideline dissemination and implementation strategies. Health Technol Assess. 2004;8(6):iii-iv,1-72.
    1. Wagner EH. The role of patient care teams in chronic disease management. BMJ. 2000;320(7234):569–572. doi: 10.1136/bmj.320.7234.569.
    1. Wood DA, Kotseva K, Connolly S, Jennings C, Mead A, Jones J, Holden A, De Bacquer D, Collier T, De Backer G, Faergeman O, EUROACTION Study Group Nurse coordinated multidisciplinary, family-based cardiovascular disease prevention programme (EUROACTION) for patients with coronary heart disease and asymptomatic individuals at high risk of cardiovascular disease: a paired, cluster-randomised controlled trial. Lancet. 2008;371(9629):1999–2012. doi: 10.1016/S0140-6736(08)60868-5.
    1. David W, Rebecca C, Amy W, Kathleen W, Russell R. Interdisciplinary team care for diabetic patients by primary care physicians, advanced practice nurses, and clinical pharmacists. Clinical Diabetes. 2011;29:260–268.
    1. Rudd P, Miller NH, Kaufman J, Kraemer HC, Bandura A, Greenwald G, Debusk RF. Nurse management for hypertension. A systems approach. Am J Hypertens. 2004;17(10):921–927.
    1. Bodenheimer T, Lorig K, Holman H, Grumbach K. Patient self-management of chronic disease in primary care. JAMA. 2002;288(19):2469–2475. doi: 10.1001/jama.288.19.2469.
    1. Kennedy A, Reeves D, Bower P, Lee V, Middleton E, Richardson G, Gardner C, Gately C, Anne Rogers A. The effectiveness and cost effectiveness of a national lay-led self-care support programme for patients with long-term conditions: a pragmatic randomised controlled trial. J Epidemiol Community Health. 2007;61(3):254–261. doi: 10.1136/jech.2006.053538.
    1. Boulware LE, Daumit GL, Frick KD, Minkovitz CS, Lawrence RS, Powe NR. An evidence-based review of patient-centered behavioral interventions for hypertension. Am J Prev Med. 2001;21(3):221–232. doi: 10.1016/S0749-3797(01)00356-7.
    1. Fischer MA, Avorn J. Economic implications of evidence-based prescribing for hypertension: can better care cost less? JAMA. 2004;291(15):1850–1856. doi: 10.1001/jama.291.15.1850.
    1. Schoen C, Osborn R, Huynh PT, Doty M, Peugh J, Zapert K. On the front lines of care: primary care doctors’ office systems, experiences and views in seven countries. Health Aff. 2006;25(6):w555–w571. doi: 10.1377/hlthaff.25.w555.
    1. Provan KG, Nakama L, Veazie MA, Teufel-Shone NI, Huddleston C. Building community capacity around chronic disease services through a collaborative interorganizational network. Health Educ Behav. 2003;30(6):646–662. doi: 10.1177/1090198103255366.
    1. Piatt GA, Orchard TJ, Emerson S, Simmons D, Songer TJ, Brooks MM, Korytkowski M, Siminerio LM, Ahmad U, Zgibor JC. Translating the chronic care model into the community: results from a randomized controlled trial of a multifaceted diabetes care intervention. Diabetes Care. 2006;29(4):811–817. doi: 10.2337/diacare.29.04.06.dc05-1785.
    1. Olivarius N, Beck-Nielsen H, Andreasen AH, Horder M, Pedersen PA. Randomised controlled trial of structured personal care of type 2 diabetes mellitus. Br Med J. 2001;323:970–975. doi: 10.1136/bmj.323.7319.970.
    1. Al-Qazaz HA, Hassali MA, Shafie AA, Sulaiman SA, Sundram S, Morisky DE. The eight-item Morisky Medication Adherence Scale MMAS: translation and validation of the Malaysian version. Diabetes Res Clin Pract. 2010;90(2):216–221. doi: 10.1016/j.diabres.2010.08.012.
    1. Glasgow RE, Wagner EH, Schaefer J, Mahoney LD, Reid RJ, Greene SM. Development and validation of the Patient Assessment of Chronic Illness Care (PACIC) Med Care. 2005;43(50):436–444. doi: 10.1097/01.mlr.0000160375.47920.8c.
    1. Martin SS, Blaha MJ, Elshazly MB, Brinton EA, Toth PP, McEvoy JW, Joshi PH, Kulkarni KR, Mize PD, Kwiterovich PO, Defilippis AP, Blumenthal RS, Jones SR. Friedewald-estimated versus directly measured low-density lipoprotein cholesterol and treatment implications. J Am Coll Cardiol. 2013;62(8):732–739. doi: 10.1016/j.jacc.2013.01.079.
    1. Starks H, Brown-Trinidad S. Choose your method: a comparison of phenomenology, discourse analysis, and grounded theory. Qual Health Res. 2007;17:1372–1380. doi: 10.1177/1049732307307031.
    1. Ministry of Health Malaysia . Pharmacoeconomic Guideline for Malaysia. Putrajaya: Pharmaceutical Services Division; 2012.
    1. Teerawattananon Y, Fukuda T, Shiroiwa T, Ahn J, Thavorncharoensap M, Shafie AA. The social value of the QALY in Asia: searching for the Holy Grail? Gaceta Sanitaria. 2012;26(Espec Congr 2):25–26.
    1. National Committee for Clinical Research, Ministry of Health Malaysia . Malaysian Guideline for Good Clinical Practice. 3 2011.
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