NYU Langone Health
This is a hybrid type II effectiveness-implementation trial using a parallel cluster randomized design. Thirty primary healthcare centers (PHCs) in Akwa Ibom State, Nigeria, will be randomized in a 1:1 ratio to the implementation group (Practice Facilitation \[PF\] + Healthy Lifestyle Counselling, Evidence-Based Protocols, Access to Essential Medicines and Technology, Risk-Based Management, Team-Based Care, and Systems for Monitoring \[HEARTS\] package) or the standard care group (HEARTS only) The study comprises two phases: an R61 Initiation Phase (Years 1-2) involving adaptation of the HEARTS package guided by the chronic care model, stakeholder engagement, infrastructure development, and pilot testing in 2 PHCs; and an R33 Implementation Phase (Years 3-5) involving the cluster RCT. Once randomized, PHCs will participate in a 12-month intervention period followed by a 6-month post-implementation period.
Inclusion Criteria: * Patients are registered to receive care at the eligible and enrolled PHC * Aged 30 years and older * Have BP 140-179/90-100 mm Hg * Have type II diabetes mellitus, defined as either: (a) a new diagnosis based on HbA1c \>6.5% measured at screening; or (b) a prior clinical diagnosis of type II DM documented in the medical record, currently not on antidiabetic treatment. Patients currently receiving antidiabetic medications are excluded. * Can provide informed consent Exclusion Criteria: * BP \>180/110 mm Hg * History of chronic kidney disease (eGFR \<35 ml/min) * History…
HEARTS is a technical package intended to: 1. Identify patients with uncontrolled DM and HTN via medical history, HbA1c assessment, and lipid profile using point-of-care testing; 2. Measure patients' weight, height, waist circumference and BP with a valid automated device following standard procedures, and assess patients' CV risk with the World Health Organization (WHO) risk chart; (3) Initiate lifestyle counseling and treatment with antihypertensive and anti-diabetic medications every 1-3 months using Federal Ministry of Health simplified protocols; and (4) Refer patients to physicians.
PF involves provision of external expertise on practice redesign and a tailored approach to implementing systems-level changes to improve patient outcomes. PF includes both a role (practice facilitator) and a process for supporting PHCs to build motivation and capacity. Six practice facilitators (each responsible for 5 PHCs) will coordinate meetings with PHC nurses, assist in setting performance goals, and strategize on HEARTS implementation through onsite visits and monthly peer-to-peer telephone calls.
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