Refinement and Testing of Recruitment Methodology for Behavioral Medication Adherence Interventions Using Behavioral Science-based Approaches (STIC2IT-2)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes; Medication Adherence; Pharmacist-Patient Relations
• Intervention / Treatment: Behavioral: Primer postcard; Behavioral: Control recruitment letter; Behavioral: 2 phone calls; Behavioral: 4 phone calls; Behavioral: Behavioral theory-informed recruitment letter (prospect theory)

• Study Type: Interventional
• Enrollment (Actual): 590
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ≥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

Exclusion Criteria:

• Evidence of terminal conditions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1; Post card; control letter; 2 calls	Behavioral: Primer postcard; Inclusion of a mailed primer post card; Behavioral: Control recruitment letter; a recruitment letter without any behaviorally-informed language; Behavioral: 2 phone calls; 2 recruitment phone calls made by the call center
Active Comparator: Arm 2; Post card; control letter; 4 calls	Behavioral: Primer postcard; Inclusion of a mailed primer post card; Behavioral: Control recruitment letter; a recruitment letter without any behaviorally-informed language; Behavioral: 4 phone calls; 4 recruitment phone calls made by the call center
Active Comparator: Arm 3; Post card; behavioral letter; 2 calls	Behavioral: Primer postcard; Inclusion of a mailed primer post card; Behavioral: 2 phone calls; 2 recruitment phone calls made by the call center; 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.
Active Comparator: Arm 4; Post card; behavioral letter; 4 calls	Behavioral: Primer postcard; Inclusion of a mailed primer post card; Behavioral: 4 phone calls; 4 recruitment phone calls made by the call center; 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.
Active Comparator: Arm 5; No post card; control letter; 2 calls	Behavioral: Control recruitment letter; a recruitment letter without any behaviorally-informed language; Behavioral: 2 phone calls; 2 recruitment phone calls made by the call center
Active Comparator: Arm 6; No post card; control letter; 4 calls	Behavioral: Control recruitment letter; a recruitment letter without any behaviorally-informed language; Behavioral: 4 phone calls; 4 recruitment phone calls made by the call center
Active Comparator: Arm 7; No post card; behavioral letter; 2 calls	Behavioral: 2 phone calls; 2 recruitment phone calls made by the call center; 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.
Active Comparator: Arm 8; No post card; behavioral letter; 4 calls	Behavioral: 4 phone calls; 4 recruitment phone calls made by the call center; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Schedule rates for clinical pharmacist adherence counseling appointment	rate of participants who scheduled an appointment	within 8 weeks of receiving the intervention
No-show/cancellation rates	rate of participants who did not show up to their appointment or cancelled their appointment after scheduling it	within 8 weeks of receiving the intervention
Glucose-lowering medication adherence	proportion of days covered of a glucose-lowering medication	3 months after randomization
Clinical outcome - HbA1c	HbA1c levels using EHR data	3 months after randomization

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Columbia University; National Institute on Aging (NIA); Boston Medical Center
• Investigators: Principal Investigator: Julie C Lauffenburger, PharmD, PhD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2025
• Primary Completion (Estimated): May 12, 2026
• Study Completion (Estimated): June 15, 2026

Study Registration Dates

• First Submitted: August 22, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Behavior; Nutritional and Metabolic Diseases; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Diabetes Mellitus; Medication Adherence
• Other Study ID Numbers: 2024P002222; 5P30AG064199-05 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No