A cluster-randomized trial of task shifting and blood pressure control in Ghana: study protocol

Gbenga Ogedegbe, Jacob Plange-Rhule, Joyce Gyamfi, William Chaplin, Michael Ntim, Kingsley Apusiga, Kiran Khurshid, Richard Cooper, Gbenga Ogedegbe, Jacob Plange-Rhule, Joyce Gyamfi, William Chaplin, Michael Ntim, Kingsley Apusiga, Kiran Khurshid, Richard Cooper

Abstract

Background: Countries in sub-Saharan Africa (SSA) are experiencing an epidemic of cardiovascular disease (CVD) propelled by rapidly increasing rates of hypertension. Barriers to hypertension control in SSA include poor access to care and high out-of-pocket costs. Although SSA bears 24% of the global disease burden, it has only 3% of the global health workforce. Given such limited resources, cost-effective strategies, such as task shifting, are needed to mitigate the rising CVD epidemic in SSA. Ghana, a country in SSA with an established community health worker program integrated within a national health insurance scheme provides an ideal platform to evaluate implementation of the World Health Organization (WHO) task-shifting strategy. This study will evaluate the comparative effectiveness of the implementation of the WHO Package targeted at CV risk assessment versus provision of health insurance coverage, on blood pressure (BP) reduction.

Methods: Using a cluster randomized design, 32 community health centers (CHCs) and district hospitals in Ghana will be randomized to either the intervention group (16 CHCs) or the control group (16 CHCs). A total of 640 patients with uncomplicated hypertension (BP 140-179/90-99 mm Hg and absence of target organ damage) will be enrolled in this study (20 patients per CHC). The intervention consists of WHO Package of CV risk assessment, patient education, initiation and titration of antihypertensive medications, behavioral counseling on lifestyle behaviors, and medication adherence every three months for 12 months. The primary outcome is the mean change in systolic BP from baseline to 12 months. The secondary outcomes are rates of BP control at 12 months; levels of physical activity, percent change in weight, and dietary intake of fruits and vegetables at 12 months; and sustainability of intervention effects at 24 months. All outcomes will be assessed at baseline, six months and 12 months. Trained community health nurses will deliver the intervention as part of Ghana's community-based health planning and services (CHPS) program.

Discussion: Findings from this study will provide policy makers and other stakeholders needed information to recommend scalable and cost-effective policy with respect to comprehensive CV risk reduction and hypertension control in resource-poor settings.

Trial registration: NCT01802372.

Figures

Figure 1
Figure 1
Overview of study design.

References

    1. Walker RW, McLarty DG, Kitange HM, Whiting D, Masuki G, Mtasiwa DM, Machibya H, Unwin N, Alberti KG. Stroke mortality in urban and rural Tanzania. Adult morbidity and mortality project. Lancet. 2000;355(9216):1684–1687. doi: 10.1016/S0140-6736(00)02240-6.
    1. Kearney PM, Whelton M, Reynolds K, Muntner P, Whelton PK, He J. Global burden of hypertension: analysis of worldwide data. Lancet. 2005;365:217–223. doi: 10.1016/S0140-6736(05)17741-1.
    1. Agyei-Mensah S, de-Graft Aikins A. Epidemiological transition and the double burden of disease in Accra, Ghana. J Urban Health. 2010;87(5):879–897. doi: 10.1007/s11524-010-9492-y.
    1. de-Graft Aikins A. Ghana’s neglected chronic disease epidemic: a developmental challenge. Ghana Med J. 2007;41(4):154–159.
    1. Addo J, Agyemang C, Smeeth L, de-Graft Aikins A, Edusei AK, Ogedegbe O. A review of population-based studies on hypertension in Ghana. Ghana Med J. 2012;46(2):4–11. Suppl.
    1. Addo J, Agyemang C, Smeeth L, DeGraft Aikins A, Edusei AK, Ogedegbe G. Hypertension in Ghana- is it a health priority? Ghana Med J. 2014. In Press.
    1. Cappuccio FP, Micah FB, Emmett L, Kerry SM, Antwi S, Martin-Peprah R, Phillips RO, Plange-Rhule J, Eastwood JB. Prevalence, detection, management, and control of hypertension in Ashanti, West Africa. Hypertension. 2004;43(5):1017–1022. doi: 10.1161/01.HYP.0000126176.03319.d8.
    1. Agyei-Mensah S. Accra (Ghana) in Transition: Epidemiological Change at the Turn of the 21st Century. Legon, Ghana: Ghana Center for Democratic Development; 2004.
    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. Mendis S, Johnston SC, Fan W, Oladapo O, Cameron A, Faramawi MF. Cardiovascular risk management and its impact on hypertension control in primary care in low resource settings; a cluster-randomized trial. Bull World Health Organ. 2010;88(6):412–419. doi: 10.2471/BLT.08.062364.
    1. Barsoum RS. Chronic kidney disease in the developing world. N Engl J Med. 2006;354(10):997–999. doi: 10.1056/NEJMp058318.
    1. Hagopian A, Thompson MJ, Fordyce M, Johnson KE, Hart LG. The migration of physicians from sub-Saharan Africa to the United States of America: measures of the African brain drain. Hum Resour Health. 2004;2(1):17. doi: 10.1186/1478-4491-2-17.
    1. Mejia A, Pizurki H, Royston E. Physician and Nurse Migration: Analysis and Policy Implications: report of a WHO study. France: World Health Organization;
    1. Pang T, Lansang MA, Haines A. Brain drain and health professionals. BMJ. 2002;324(7336):499–500. doi: 10.1136/bmj.324.7336.499.
    1. Unwin N, Setel P, Rashid S, Mugusi F, Mbanya JC, Kitange H, Hayes L, Edwards R, Aspray T, Alberti KG. Noncommunicable diseases in sub-Saharan Africa: where do they feature in the health research agenda? Bull World Health Organ. 2001;79:947–953.
    1. Anangwe SC, Mtonga C. Inequities in the global health workforce: the greatest impediment to health in sub-Saharan Africa. Int J Environ Res Public Health. 2007;4(2):93–100. doi: 10.3390/ijerph2007040002.
    1. Twagirumukiza M, Van Bortel LM. Management of hypertension at the community level in Sub-Saharan Africa (SSA): towards a rational use of available resources. J Hum Hyperten. 2011;25:47–56. doi: 10.1038/jhh.2010.32.
    1. Opie LH, Seedat YK. Hypertension in Sub-Saharan African populations. Circulation. 2005;112:3562–3568. doi: 10.1161/CIRCULATIONAHA.105.539569.
    1. World Medical Association Word Medical Association Resolution on task shifting from the medical profession. [ ]
    1. Lekoubou A, Awah P, Fezeu L, Sobngwi E, Kengne AP. Hypertension, diabetes mellitus and task shifting in their management in Sub-Saharan Africa. Int J Environ Res Public Health. 2010;7:353–363. doi: 10.3390/ijerph7020353.
    1. Zachariah R, Ford N, Phillips M. Task shifting in HIV/AIDS: opportunities, challenges and proposed actions for sub-Saharan Africa. Trans R Soc Trop Med Hyg. 2009;103(6):549–558. doi: 10.1016/j.trstmh.2008.09.019.
    1. Ogedegbe G, Tobin JN, Fernandez S, Gerin W, Diaz-Gloster M, Cassells A, Khalida C, Pickering T, Schoenthaler A, Ravenell J. Counseling African Americans to Control Hypertension (CAATCH) trial: a multi-level intervention to improve blood pressure control in hypertensive blacks. Circ Cardiovasc Qual Outcomes. 2009;2(3):249–256. doi: 10.1161/CIRCOUTCOMES.109.849976.
    1. Bradley HA, Puoane T. Prevention of hypertension and diabetes in an urban setting in South Africa: participatory action research with community health workers. Ethn Dis. 2007;17(1):49–54.
    1. Labhardt ND, Balo JR, Ndam M, Grimm JJ, Manga E. Task shifting to non-physician clinicians for intergrated management of hypertension and diabetes in rural Cameroon: a programme assessment at two years. BMC Health Serv Res. 2010;10:339–348. doi: 10.1186/1472-6963-10-339.
    1. WHO CVD Risk Management Package for low-and medium-Resource Settings. Geneva: World Health Organization; 2002.
    1. Nguyen HT, Rajkotian Y, Wang H. The financial protection effect of Ghana National Health Insurance Scheme: evidence from a study in two rural districts. Int J Equity Health. 2011;10:4. doi: 10.1186/1475-9276-10-4.
    1. Nyonator FK, Awoonor-Williams JK, Phillips JF. The Ghana community-based health planning and services initiative for scaling up service delivery innovation. Health Policy Plan. 2005;20(1):25–34. doi: 10.1093/heapol/czi003.
    1. Mendis S, Abegunde D, Oladapo O, Celletti F, Nordet P. Barriers to management of cardiovascular risk in a low-resource setting using hypertension as an entry point. J Hypertens. 2004;22(1):59–64. doi: 10.1097/00004872-200401000-00013.
    1. Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gøtzsche PC, Lang T. CONSORT GROUP (Consolidated Standards of Reporting Trials) The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001;134(8):663–694. doi: 10.7326/0003-4819-134-8-200104170-00012.
    1. WHO. Global recommendations and guidelines. .
    1. Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ. Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. National Heart, Lung, and Blood Institute; National High Blood Pressure Education Program Coordinating Committee. Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension. 2003;42(6):1206–1252. doi: 10.1161/01.HYP.0000107251.49515.c2.
    1. Gonzalvo J, Zillich A. Accuracy of automated community pharmacy-based blood pressure devices. J Am Pharm Assoc. 2003;51(3):408–411.
    1. Pickering TG, Hall JE, Appel LJ. Recommendations for blood pressure measurement in humans and experimental animals- part 1: blood pressure measurement in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Hypertension. 2005;45:142–161. doi: 10.1161/01.HYP.0000150859.47929.8e.
    1. Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986;24(1):67–74. doi: 10.1097/00005650-198601000-00007.
    1. Steyn NP, Nel JH. Dietary intake of adult women in South Africa and Nigeria with a focus on the use of spreads. .
    1. Venter CS, MacIntyre UE, Vorster HH. The development and testing of a food portion photograph book for use in an African population. J Hum Nutr Diet. 2000;13(3):205–218. doi: 10.1046/j.1365-277x.2000.00228.x.
    1. The Global Physical Activity Questionnaire (GPAQ) Available online: [ ]
    1. Cary NC. SAS [Computer Program]. Version 9. SAS Institute INC; 2005.
    1. Holm S. A simple sequentially rejective multiple test procedure. Scand J Stat. 1979;6:65–70.
    1. Twagirumukiza M, De Bacquer D, Kips JG, de Backer G, Stichele RV, Van Bortel LM. Current and projected prevalence of arterial hypertension in sub-Saharan Africa by sex, age and habitat: an estimate from population studies. J Hyperten. 2011;29(7):1243–1252. doi: 10.1097/HJH.0b013e328346995d.
    1. Abegunde DO, Shengelia B, Luyten A, Cameron A, Celletti F, Nishtar S, Pandurangi V, Mendis S. Can non-physician health-care workers assess and manage cardiovascular risk in primary care? Bull World Health Organ. 2007;85(6):432–440. doi: 10.2471/BLT.06.032177.
    1. Carapinha JL, Ross-Degnan D, Desta T, Wagner AK. Health insurance systems in five Sub-Saharan African countries: medicine benefits and data for decision making. Health Policy. 2011;99(3):193–202. doi: 10.1016/j.healthpol.2010.11.009.
    1. Alwan A, Maclean D, Mandil A. Assessment of national capacity for noncommunicable disease prevention and control; the report of a global survey, 2001, World Health Organization 2001. .

Source: PubMed

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

3
Subskrybuj