Strengthening Referral Networks for Management of Hypertension Across the Health System (STRENGTHS) in western Kenya: a study protocol of a cluster randomized trial

Trials

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[1] 0000 0001 0495 4256, grid.79730.3a, Moi University School of Medicine, PO Box 4606, 30100, Eldoret, Kenya;0000 0001 2156 6853, grid.42505.36, Keck School of Medicine University of Southern California, 2001 N Soto Street, Soto Street Building, Suite 330, MC 9239, 90089-9239, Los Angeles, CA, USA;0000 0001 2287 3919, grid.257413.6, Indiana University School of Medicine, 535 Barnhill Dr., 46202, Indianapolis, IN, USA;0000 0004 0385 0924, grid.428397.3, Duke-NUS Medical School, Singapore, 8 College Road, 169857, Singapore, Singapore;0000 0004 1936 7961, grid.26009.3d, Duke University School of Medicine, Duke Clinical Research Institute and Duke Global Health Institute, 2301 Erwin Rd., 27704, Durham, NC, USA;0000 0004 1936 8753, grid.137628.9, New York University School of Medicine, 180 Madison Avenue, 8th Floor, 10016, New York, NY, USA;0000 0004 1936 9924, grid.89336.37, The University of Texas at Austin Dell Medical School, 1701 Trinity St., 78712, Austin, TX, USA;0000 0004 1937 2197, grid.169077.e, Purdue University College of Pharmacy, 575 Stadium Mall Dr., 47907, West Lafayette, IN, USA;Moi Teaching and Referral Hospital, PO Box 3-30100, Eldoret, Kenya;

关键词: Referral networks;    Hypertension;    Cardiovascular disease;    Health systems;    Health systems strengthening;    Implementation science;    Health information technology;    Peer support;    Low- and middle-income countries (LMICs);    Kenya;   

DOI  :  10.1186/s13063-019-3661-4

来源: publisher

【 摘 要 】

BackgroundHypertension is a major risk factor for cardiovascular disease (CVD), yet treatment and control rates for hypertension are very low in low- and middle-income countries (LMICs). Lack of effective referral networks between different levels of the health system is one factor that threatens the ability to achieve adequate blood pressure control and prevent CVD-related morbidity. Health information technology and peer support are two strategies that have improved care coordination and clinical outcomes for other disease entities in other settings; however, their effectiveness and cost-effectiveness in strengthening referral networks to improve blood pressure control and reduce CVD risk in low-resource settings are unknown.Methods/designWe will use the PRECEDE-PROCEED framework to conduct transdisciplinary implementation research, focused on strengthening referral networks for hypertension in western Kenya. We will conduct a baseline needs and contextual assessment using a mixed-methods approach, in order to inform a participatory, community-based design process to fully develop a contextually and culturally appropriate intervention model that combines health information technology and peer support. Subsequently, we will conduct a two-arm cluster randomized trial comparing 1) usual care for referrals vs 2) referral networks strengthened with our intervention. The primary outcome will be one-year change in systolic blood pressure. The key secondary clinical outcome will be CVD risk reduction, and the key secondary implementation outcomes will include referral process metrics such as referral appropriateness and completion rates. We will conduct a mediation analysis to evaluate the influence of changes in referral network characteristics on intervention outcomes, a moderation analysis to evaluate the influence of baseline referral network characteristics on the effectiveness of the intervention, as well as a process evaluation using the Saunders framework. Finally, we will analyze the incremental cost-effectiveness of the intervention relative to usual care, in terms of costs per unit decrease in systolic blood pressure, per percentage change in CVD risk score, and per disability-adjusted life year saved.DiscussionThis study will provide evidence for the implementation of innovative strategies for strengthening referral networks to improve hypertension control in LMICs. If effective, it has the potential to be a scalable model for health systems strengthening in other low-resource settings worldwide.Trial registrationClinicaltrials.gov, NCT03543787. Registered on 29 June 2018.

【 授权许可】

CC BY