Hypertension disproportionally affects populations in low- and middle-income countries (LMICs), especially in Latin America and the Caribbean (LAC), with a high prevalence and low control rate, resulting in an excess burden of cardiovascular disease (CVD). Despite widely available evidence-based interventions, only 7.7% of patients in LMICs had their blood pressure (BP) controlled in 2010. To close the knowledge-practice gap for hypertension control in LAC, a multidisciplinary team of investigators from Colombia, Jamaica, and the US will work with national and local government agencies and health systems to test the implementation and effectiveness outcomes of implementing and scaling up a team-based care strategy for BP control in Colombia and Jamaica. The RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) framework is being used to guide the development and evaluation of the implementation strategies. Physician-nurse (or pharmacist)-community health worker (CHW) teams will work collaboratively with patients to achieve shared treatment goals. Nurses or pharmacists will titrate medications using a simple protocol under physician supervision, CHWs will conduct health coaching on lifestyle change and medication adherence, and patients will actively engage in self-management (including home BP monitoring).
Specific Aim 1 will test the reach, effectiveness, adoption, implementation (fidelity), and maintenance (sustainability) of implementing a team- based care strategy in a cluster randomized trial. A total of 40 primary care clinics (20 from Colombia and 20 from Jamaica; 32 patients per clinic and 1,280 in total) will be randomly assigned to a team-based care strategy or enhanced usual care for 12 months to test implementation and effectiveness outcomes. A 6-month post-trial follow-up study will be conducted to assess sustainability. This trial has 90% statistical power to detect an absolute difference of 15% in hypertension control (BP<140/90 mm Hg) using a 2-sided significance level of 0.05.
Specific Aim 2 will assess barriers and implementation outcomes of scaling up a team-based care strategy in an observational study. Training will be provided to scale up team-based care in all remaining 141 primary care clinics (78 from Colombia and 63 from Jamaica) after the cluster trial. However, scale-up activities will not be supported by external funding. Barriers and implementation outcomes will be collected using interview, survey, and administrative data at primary care clinic and provider team levels. In addition, we will be able to compare implementation outcomes among 3 groups ? intervention with external funding (clinics in the trial intervention group), intervention without external funding (clinics in the observational study), and usual care (clinics in the trial control group). We will conduct mediation analyses to understand the mechanisms of team-based care on BP control and a cost-effectiveness analysis to estimate implementation costs. The proposed study will identify effective, equitable, and sustainable strategies to achieve hypertension control in routine clinical settings and reduce CVD risk in the general population of LAC and other LMICs.
In the proposed study, a multidisciplinary team of investigators from Colombia, Jamaica, and the US will work with national and local government agencies and health systems to test the implementation and effectiveness outcomes of implementing and scaling up a team-based care strategy for hypertension control in Colombia and Jamaica. This study will identify effective, equitable, and sustainable strategies to achieve hypertension control in routine clinical settings and reduce cardiovascular risk in the general population of Latin America and the Caribbean, as well as other low- and middle-income countries.
