Interactive voice response and text message (IVR‐T) technology may improve hypertension control in under‐resourced settings. We conducted a randomized clinical trial to determine whether an IVR‐T intervention would improve blood pressure (BP), medication adherence and visit keeping among adults with hypertension from multiple racial and ethnic groups in primary care at an Urban Indian Health Organization in Albuquerque, New Mexico. Two hundred and ninety‐five participants were randomly assigned to IVR‐T (N = 148) or to usual care (N = 147). The IVR‐T arm received reminders for clinic visits, messages to reschedule missed clinic visits, monthly medication refill reminders, weekly motivational messages, and a blood pressure cuff. The usual care arm received no messages. The primary outcome was change in systolic BP (SBP) between baseline and 12 months. Secondary outcomes included change in SBP between baseline and 6 months, change in diastolic BP (DBP) at 6 and 12 months, self‐reported adherence at 6 months, and the proportion of missed primary care clinic appointments. The intervention did not affect SBP or DBP at 6 or 12 months. The 12‐month change in SBP/DBP was 1.66/1.10 mm Hg in usual care and 0.23/1.34 mm Hg in the intervention group (P values = .57 and .88, respectively). Self‐reported medication adherence improved comparably in both groups, and there was no difference in percentage of kept visits. Several features of study design, clinic operations, and data transfer were barriers to demonstrating effectiveness.

Background: Hypertension is a major risk factor for cardiovascular disease (CVD). Despite advances in hypertension prevention and treatment, the proportion of patients who are aware, treated and controlled is low, particularly in lowincome and middle-income countries (LMICs). We will evaluate an adapted version of a multilevel and multicomponent hypertension control program in Guatemala, previously proven effective and feasible in Argentina. The program components are: protocol-based hypertension treatment using a standardized algorithm; team-based collaborative care; health provider education; health coaching sessions; home blood pressure monitoring; blood pressure audit; and feedback. Methods: Using a hybrid type 2 effectiveness-implementation design, we will evaluate clinical and implementation outcomes of the multicomponent program in Guatemala over an 18-month period. Through a cluster randomized trial, we will randomly assign 18 health districts to the intervention arm and 18 to enhanced usual care across five departments, enrolling 44 participants per health district and 1584 participants in total. The clinical outcomes are (1) the difference in the proportion of patients with controlled hypertension (< 130/80 mmHg) between the intervention and control groups at 18 months and (2) the net change in systolic and diastolic blood pressure from baseline to 18 months. The context-enhanced Reach, Efficacy, Adoption, Implementation, Maintenance (RE-AIM)/Practical Robust Implementation and Sustainability Model (PRISM) framework will guide the evaluation of the implementation at the level of the patient, provider, and health system. Using a mixed-methods approach, we will evaluate the following implementation outcomes:

IntroductionImplementation science frameworks have been used widely for planning and evaluation, but seldom to guide adaptations during program implementation. There is great potential for these frameworks to be used to inform conceptual and data-driven decisions about adaptations.MethodsWe summarize recent applications using Iterative RE-AIM to capture and guide adaptations. Iterative RE-AIM can be repeated at multiple time points customized to each project and involves the following activities: identification of key implementation partners; rating importance of and progress on each RE-AIM dimension (reach, effectiveness, adoption, implementation, and maintenance); use of summary data on ratings to identify one or two RE-AIM dimensions for adaptations and implementation strategies; and evaluation of progress and impact of adaptations. We summarize recent and ongoing Iterative RE-AIM applications across multiple care coordination and pain management projects within the Veterans Health Administration, a hypertension control trial in Guatemala, a hospital-based lung ultrasound implementation pilot, and a colorectal cancer screening program in underserved communities.ResultsIterative RE-AIM appears feasible, helpful, and broadly applicable across diverse health care issues, interventions, contexts, and populations. In general, the RE-AIM dimension showing the largest gap between importance and progress has been Reach. The dimensions most frequently selected for improvement have been Reach and Implementation. We discuss commonalities, differences and lessons learned across these various applications of Iterative RE-AIM. Challenges include having objective real time data on which to make decisions, having key implementation staff available for all assessments, and rapidly scoring and providing actionable feedback. We discuss print and online resources and materials to support Iterative RE-AIM.ConclusionsThe use of Iterative RE-AIM to guide and support understanding of adaptations has proven feasible across diverse projects and in multiple case studies, but there are still questions about its strengths, limitations, essential components, efficiency, comparative effectiveness, and delivery details. Future directions include investigating the optimal frequency and timing for iterative applications; adding contextual assessments; developing more continuous and rapid data on which to make adaptation decisions; identifying opportunities to enhance health equity; and determining the level of facilitation that is most cost-effective.

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