Refinement and Testing of Recruitment Methodology for Behavioral Medication Adherence Interventions Using Behavioral Science-based Approaches

Summary

The overarching goal of the proposed research is to prepare the clinical pharmacist intervention for sustainable implementation and dissemination. Because the effectiveness of the intervention has already been demonstrated in a NIH Stage Model IV trial, the investigators propose an Effectiveness-Implementation Type 3 Hybrid design, in which the primary focus is on testing different implementation methods, while secondarily observing clinical effects. The investigators' overarching hypothesis is to identify the most impactful elements of a behavioral theory-informed recruitment approach, which can be replicable across clinical settings.

Accordingly, the investigators propose to perform testing of a behaviorally-informed recruitment approaches in a community-based setting. Like the previous Tele-Pharmacy Intervention to Improve Treatment Adherence (STIC2IT) trial (NCT02512276), participants will be English or Spanish speaking adults ≥18 years of age identified through the electronic health record (EHR) as having poor disease control and/or poor medication adherence for diabetes. The primary care physicians of eligible patients identified through the EHR will be contacted 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 the preliminary study using prospect theory (versus the control letter), and (3) intensity of the intervention outreach (4 calls vs. 2 calls). The investigators plan to enroll 584 participants who meet the inclusion criteria, with 73 patients per each of the 8 study arms.

Patients across all arms who agree to be scheduled will receive an appointment with one of the clinical pharmacists within the established BMC pharmacist program. The primary outcome will be completion of a clinical pharmacist appointment within 8 weeks after randomization. Key secondary outcomes will include scheduled visit rates, no-show rates for scheduled appointments, medication adherence over the 3-month follow-up, and clinical outcomes, including HbA1c levels measured using EHR data in the 3 months after randomization. The medication adherence and clinical outcomes will be used for the Aim 2 evaluation.

Conditions

• Diabetes
• Pharmacist-Patient Relations
• Medication Adherence

Interventions

BEHAVIORAL

Primer postcard

Inclusion of a mailed primer post card

BEHAVIORAL

Control recruitment letter

a recruitment letter without any behaviorally-informed language

BEHAVIORAL

Behavioral theory-informed recruitment letter (prospect theory)

the recruitment letter will use prospect theory and deliver a low risk, gain-framed behaviorally-informed message.

BEHAVIORAL

2 phone calls

2 recruitment phone calls made by the call center

BEHAVIORAL

4 phone calls

4 recruitment phone calls made by the call center

Sponsors & Collaborators

• National Institute on Aging (NIA)

  collaborator NIH

• Boston Medical Center

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Brigham and Women's Hospital

  lead OTHER

Principal Investigators

• Julie C Lauffenburger, PharmD, PhD · Brigham and Women's Hospital

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

2025-03-03

Primary Completion

2026-05-12

Completion

2026-06-15

Countries

• United States

Study Locations