Clinical trial NCT06569290: Refinement and Testing of Recruitment Methodology for Behavioral Medication Adherence Interventions Using Behavioral Science-based Approaches
Official title: Refinement and Testing of Recruitment Methodology for Behavioral Medication Adherence Interventions Using Behavioral Science-based Approaches
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
Pharmacist-Patient Relations
Medication Adherence
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Boston Medical Center
name: Columbia University
First posted: 2024-08-26
Enrollment: 584
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Completion of a clinical pharmacist adherence counseling appointment
timeFrame: within 8 weeks of receiving the intervention
Secondary outcomes:
measure: Schedule rates for clinical pharmacist adherence counseling appointment
timeFrame: within 8 weeks of receiving the intervention
measure: No-show/cancellation rates
timeFrame: within 8 weeks of receiving the intervention
measure: Glucose-lowering medication adherence
timeFrame: 3 months after randomization
measure: Clinical outcome - HbA1c
timeFrame: 3 months after randomization
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Niteesh K Choudhry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: