Engaging Patients in Adherence Interventions Using Behavioral Science
NCT Number: NCT06543394
Acronym: ENGAGE-HTN
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Uncontrolled Hypertension
Interventions: BEHAVIORAL: Primer postcard|BEHAVIORAL: Control recruitment letter|BEHAVIORAL: Behavioral theory-informed recruitment letter|BEHAVIORAL: 2 phone calls|BEHAVIORAL: 4 phone calls
Sponsor: Columbia University
Collaborators: National Institute on Aging (NIA)|Brigham and Women's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 584
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08
Completion Date: 2026-07
Locations: Columbia University Irving Medical Center, New York, New York, 10032, United States

Summary:
The overarching goal of the proposed research is to prepare an evidence-based clinical pharmacist-delivered medication adherence intervention for sustainable implementation and dissemination. Because the effectiveness of the intervention has already been demonstrated in a NIH Stage Model Stage 4 trial called STIC2IT, we propose an NIH Stage Model Stage 5 Effectiveness-Implementation Type 3 Hybrid design, in which our primary focus is on testing different implementation methods, while secondarily observing clinical effects. Our overarching hypothesis is that we can identify the most impactful elements of a behavioral theory-informed recruitment approach, which can be replicable across clinical settings.

Accordingly, we propose to perform testing of behaviorally-informed recruitment approaches in a primary care setting that serves patients from under-resourced communities. Patients will be English or Spanish speaking adults ≥18 years of age identified through the electronic health record (EHR) as having a primary care clinician at the participating practice as well as uncontrolled hypertension and suboptimal adherence to blood pressure medications based on pharmacy fill data linked to the electronic health record (EHR). The primary care clinicians of eligible patients identified through the EHR will have the opportunity to opt-out any patients they wish not to be included. Patients will then be randomized to each of the following conditions, such that there will be 8 total arms: (1) inclusion of a mailer primer (yes/no), (2) the most successful recruitment letter from a preliminary study using prospect theory (versus the control letter), and (3) intensity of the intervention outreach (up to 4 calls vs. up to 2 calls).

Patients across all arms who agree to be scheduled will receive an appointment with one of the clinical pharmacists trained in the brief negotiated interviewing approach used in the STIC2IT trial. The primary outcome will be completion of a clinical pharmacist appointment within 12 weeks of randomization. Key secondary outcomes will include scheduled visit rates, no-show rates for scheduled appointments, pharmacy fill adherence to statins and blood pressure medications over the 3-month follow-up, and clinical outcomes, including blood pressure as per EHR data in the 3 months after randomization.

Primary Outcome Measures: Number of participants who completed an adherence counseling session, Measures patient attendance at a single adherence counseling session, 12 weeks
Secondary Outcome Measures: Number of participants who scheduled an adherence counseling session, Patient scheduled an adherence counseling session, 12 weeks|Number of days that participants were adherent to blood pressure medication, Number of days covered for blood pressure medications \>= 80%, 12 weeks|Number of days that participants were adherent to statin medication, Number of days covered for statin medications \>= 80%, 12 weeks|Systolic blood pressure, Systolic blood pressure at office visit, 12 weeks|Diastolic blood pressure, Diastolic blood pressure at office visit, 12 weeks