Refinement and Testing of Recruitment Methodology for Behavioral Medication Adherence Interventions Using Behavioral Science-based Approaches
NCT ID: NCT06569290
Last Updated: 2025-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
584 participants
INTERVENTIONAL
2025-03-03
2026-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Arm 1
Post card; control letter; 2 calls
Primer postcard
Inclusion of a mailed primer post card
Control recruitment letter
a recruitment letter without any behaviorally-informed language
2 phone calls
2 recruitment phone calls made by the call center
Arm 2
Post card; control letter; 4 calls
Primer postcard
Inclusion of a mailed primer post card
Control recruitment letter
a recruitment letter without any behaviorally-informed language
4 phone calls
4 recruitment phone calls made by the call center
Arm 3
Post card; behavioral letter; 2 calls
Primer postcard
Inclusion of a mailed primer post card
Behavioral theory-informed recruitment letter (prospect theory)
the recruitment letter will use prospect theory and deliver a low risk, gain-framed behaviorally-informed message.
2 phone calls
2 recruitment phone calls made by the call center
Arm 4
Post card; behavioral letter; 4 calls
Primer postcard
Inclusion of a mailed primer post card
Behavioral theory-informed recruitment letter (prospect theory)
the recruitment letter will use prospect theory and deliver a low risk, gain-framed behaviorally-informed message.
4 phone calls
4 recruitment phone calls made by the call center
Arm 5
No post card; control letter; 2 calls
Control recruitment letter
a recruitment letter without any behaviorally-informed language
2 phone calls
2 recruitment phone calls made by the call center
Arm 6
No post card; control letter; 4 calls
Control recruitment letter
a recruitment letter without any behaviorally-informed language
4 phone calls
4 recruitment phone calls made by the call center
Arm 7
No post card; behavioral letter; 2 calls
Behavioral theory-informed recruitment letter (prospect theory)
the recruitment letter will use prospect theory and deliver a low risk, gain-framed behaviorally-informed message.
2 phone calls
2 recruitment phone calls made by the call center
Arm 8
No post card; behavioral letter; 4 calls
Behavioral theory-informed recruitment letter (prospect theory)
the recruitment letter will use prospect theory and deliver a low risk, gain-framed behaviorally-informed message.
4 phone calls
4 recruitment phone calls made by the call center
Interventions
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Primer postcard
Inclusion of a mailed primer post card
Control recruitment letter
a recruitment letter without any behaviorally-informed language
Behavioral theory-informed recruitment letter (prospect theory)
the recruitment letter will use prospect theory and deliver a low risk, gain-framed behaviorally-informed message.
2 phone calls
2 recruitment phone calls made by the call center
4 phone calls
4 recruitment phone calls made by the call center
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Boston Medical Center
OTHER
Columbia University
OTHER
Brigham and Women's Hospital
OTHER
Responsible Party
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Niteesh K. Choudhry, MD, PhD
Professor
Principal Investigators
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Niteesh K Choudhry, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Boston Medical Center
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024P002222
Identifier Type: -
Identifier Source: org_study_id
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