Engaging Patients in Adherence Interventions Using Behavioral Science

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, this study will include an NIH Stage Model Stage 5 Effectiveness-Implementation Type 3 Hybrid design, in which the primary focus is on testing different implementation methods, while secondarily observing clinical effects. The overarching hypothesis is that investigators can identify the most impactful elements of a behavioral theory-informed recruitment approach, which can be replicable across clinical settings.

Accordingly, this study will 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.

Conditions

• Uncontrolled Hypertension

Interventions

BEHAVIORAL

Primer postcard

Mailed primer postcard

BEHAVIORAL

Control recruitment letter

Mailed recruitment letter with usual care message framing

BEHAVIORAL

Behavioral theory-informed recruitment letter

Mailed recruitment letter with prospect-theory informed message framing

BEHAVIORAL

2 phone calls

Up to 2 phone call attempts to schedule patient for a clinical pharmacist adherence counseling visit

BEHAVIORAL

4 phone calls

Up to 4 phone call attempts to schedule patient for a clinical pharmacist adherence counseling visit

Sponsors & Collaborators

• National Institute on Aging (NIA)

  collaborator NIH

• Brigham and Women's Hospital

  collaborator OTHER

• Columbia University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-08

Primary Completion

2027-06-30

Completion

2027-09-30

Countries

• United States

Study Locations