Refinement and Testing of Recruitment Methodology for Behavioral Medication Adherence Interventions Using Behavioral Science-based Approaches
- Conditions
- Pharmacist-Patient RelationsMedication AdherenceDiabetes
- Interventions
- Behavioral: Primer postcardBehavioral: Control recruitment letterBehavioral: Behavioral theory-informed recruitment letter (prospect theory)Behavioral: 4 phone callsBehavioral: 2 phone calls
- Registration Number
- NCT06569290
- Lead Sponsor
- Brigham and Women's Hospital
- 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, we propose an 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 a behaviorally-informed recruitment approaches in a community-based setting. Like the STIC2IT trial, 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. Subjects 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). We 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 584
- ≥18 years of age
- English or Spanish speaking
- Receiving care from a BMC primary care provider
- Non-adherent to their 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
- Evidence of terminal conditions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Arm 4 Primer postcard Post card; behavioral letter; 4 calls Arm 2 4 phone calls Post card; control letter; 4 calls Arm 3 Primer postcard Post card; behavioral letter; 2 calls Arm 2 Control recruitment letter Post card; control letter; 4 calls Arm 3 Behavioral theory-informed recruitment letter (prospect theory) Post card; behavioral letter; 2 calls Arm 3 2 phone calls Post card; behavioral letter; 2 calls Arm 1 Primer postcard Post card; control letter; 2 calls Arm 1 Control recruitment letter Post card; control letter; 2 calls Arm 1 2 phone calls Post card; control letter; 2 calls Arm 2 Primer postcard Post card; control letter; 4 calls Arm 4 Behavioral theory-informed recruitment letter (prospect theory) Post card; behavioral letter; 4 calls Arm 4 4 phone calls Post card; behavioral letter; 4 calls Arm 5 Control recruitment letter No post card; control letter; 2 calls Arm 5 2 phone calls No post card; control letter; 2 calls Arm 6 Control recruitment letter No post card; control letter; 4 calls Arm 6 4 phone calls No post card; control letter; 4 calls Arm 7 Behavioral theory-informed recruitment letter (prospect theory) No post card; behavioral letter; 2 calls Arm 7 2 phone calls No post card; behavioral letter; 2 calls Arm 8 Behavioral theory-informed recruitment letter (prospect theory) No post card; behavioral letter; 4 calls Arm 8 4 phone calls No post card; behavioral letter; 4 calls
- Primary Outcome Measures
Name Time Method Completion of a clinical pharmacist adherence counseling appointment within 8 weeks of receiving the intervention rate of participants who completed their clinical pharmacist consultation
- Secondary Outcome Measures
Name Time Method Glucose-lowering medication adherence 3 months after randomization proportion of days covered of a glucose-lowering medication
Clinical outcome - HbA1c 3 months after randomization HbA1c levels using EHR data
Schedule rates for clinical pharmacist adherence counseling appointment within 8 weeks of receiving the intervention rate of participants who scheduled an appointment
No-show/cancellation rates within 8 weeks of receiving the intervention rate of participants who did not show up to their appointment or cancelled their appointment after scheduling it
Trial Locations
- Locations (1)
Boston Medical Center
🇺🇸Boston, Massachusetts, United States