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

NCT06569290 | Active Not Recruiting

• 2 other identifiers: 2024P0022225P30AG064199-05
• Study Type: interventional
• Target: 590
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Completion of a clinical pharmacist adherence counseling appointment

  rate of participants who completed their clinical pharmacist consultation

  within 8 weeks of receiving the intervention

Secondary Outcomes (4)

• Schedule rates for clinical pharmacist adherence counseling appointment

  within 8 weeks of receiving the intervention

• No-show/cancellation rates

  within 8 weeks of receiving the intervention

• Glucose-lowering medication adherence

  3 months after randomization

• Clinical outcome - HbA1c

  3 months after randomization

Study Arms (8)

Arm 1

ACTIVE COMPARATOR

Post card; control letter; 2 calls

Behavioral: Primer postcard; Behavioral: Control recruitment letter; Behavioral: 2 phone calls

Arm 2

ACTIVE COMPARATOR

Post card; control letter; 4 calls

Behavioral: Primer postcard; Behavioral: Control recruitment letter; Behavioral: 4 phone calls

Arm 3

ACTIVE COMPARATOR

Post card; behavioral letter; 2 calls

Behavioral: Primer postcard; Behavioral: Behavioral theory-informed recruitment letter (prospect theory); Behavioral: 2 phone calls

Arm 4

ACTIVE COMPARATOR

Post card; behavioral letter; 4 calls

Behavioral: Primer postcard; Behavioral: Behavioral theory-informed recruitment letter (prospect theory); Behavioral: 4 phone calls

Arm 5

ACTIVE COMPARATOR

No post card; control letter; 2 calls

Behavioral: Control recruitment letter; Behavioral: 2 phone calls

Arm 6

ACTIVE COMPARATOR

No post card; control letter; 4 calls

Behavioral: Control recruitment letter; Behavioral: 4 phone calls

Arm 7

ACTIVE COMPARATOR

No post card; behavioral letter; 2 calls

Behavioral: Behavioral theory-informed recruitment letter (prospect theory); Behavioral: 2 phone calls

Arm 8

ACTIVE COMPARATOR

No post card; behavioral letter; 4 calls

Behavioral: Behavioral theory-informed recruitment letter (prospect theory); Behavioral: 4 phone calls

Interventions

4 phone calls BEHAVIORAL

4 recruitment phone calls made by the call center

Arm 2; Arm 4; Arm 6; Arm 8

Primer postcard BEHAVIORAL

Inclusion of a mailed primer post card

Arm 1; Arm 2; Arm 3; Arm 4

Control recruitment letter BEHAVIORAL

a recruitment letter without any behaviorally-informed language

Arm 1; Arm 2; Arm 5; Arm 6

Behavioral theory-informed recruitment letter (prospect theory) BEHAVIORAL

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

Arm 3; Arm 4; Arm 7; Arm 8

2 phone calls BEHAVIORAL

2 recruitment phone calls made by the call center

Arm 1; Arm 3; Arm 5; Arm 7

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• English or Spanish speaking
• Receiving care from a BMC primary care provider
• Non-adherent to prescribed oral glucose-lowering medications as per pharmacy dispense records (proportion of days covered \<80% to at least one eligible medication in last 6 months)
• Evidence of poor or worsening disease control

You may not qualify if:

• Evidence of terminal conditions

Sponsors & Collaborators

• Boston Medical Center: collaborator
• Brigham and Women's Hospital: lead
• National Institute on Aging (NIA): collaborator
• Columbia University: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Medication Adherence

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Julie C Lauffenburger, PharmD, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Principal investigators and data analysts will be masked to group assignment when analyzing data to determine the effectiveness of the recruitment strategy.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: March 3, 2025
• Primary Completion (Estimated): May 12, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)