1. Strengthening Referral Networks for Management of Hypertension Across the Health System (STRENGTHS) in western Kenya: a study protocol of a cluster randomized trial
- Author
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Ann Mwangi, Constantine Akwanalo, Sonak D. Pastakia, Rajesh Vedanthan, Gerald S. Bloomfield, Violet Naanyu, Thomas W. Valente, Tim Mercer, Jemima H. Kamano, Benson Njuguna, Jonathan J. Dick, and Eric A. Finkelstein
- Subjects
Adult ,Referral ,Health information technology ,Cost-Benefit Analysis ,Medicine (miscellaneous) ,030204 cardiovascular system & hematology ,Peer support ,03 medical and health sciences ,Study Protocol ,0302 clinical medicine ,Health systems ,Intervention (counseling) ,Medicine ,Cluster Analysis ,Humans ,Pharmacology (medical) ,030212 general & internal medicine ,Cluster randomised controlled trial ,Health systems strengthening ,Referral and Consultation ,Referral networks ,Randomized Controlled Trials as Topic ,Protocol (science) ,lcsh:R5-920 ,business.industry ,Risk factor (computing) ,medicine.disease ,Cardiovascular disease ,Kenya ,3. Good health ,Research Design ,Low- and middle-income countries (LMICs) ,Hypertension ,Implementation science ,Implementation research ,Medical emergency ,business ,lcsh:Medicine (General) ,Delivery of Health Care ,Medical Informatics - Abstract
Background Hypertension 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/design We 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. Discussion This 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 registration Clinicaltrials.gov, NCT03543787. Registered on 29 June 2018.
- Published
- 2019