Engaging Patients in Adherence Interventions Using Behavioral Science
ENGAGE-HTN
Optimizing Recruitment Methodology for Medication Adherence Interventions: The ENGaging Patients in Adherence Interventions UsinG Behavioral SciencE (ENGAGE) Randomized Factorial Trial
2 other identifiers
interventional
584
1 country
1
Brief Summary
The overarching goal of the proposed research is to prepare an evidence-based clinical pharmacist-delivered medication adherence intervention for sustainable implementation and dissemination. Because the effectiveness of the intervention has already been demonstrated in a NIH Stage Model Stage 4 trial called STIC2IT, this study will include an NIH Stage Model Stage 5 Effectiveness-Implementation Type 3 Hybrid design, in which the primary focus is on testing different implementation methods, while secondarily observing clinical effects. The overarching hypothesis is that investigators can identify the most impactful elements of a behavioral theory-informed recruitment approach, which can be replicable across clinical settings. Accordingly, this study will perform testing of behaviorally-informed recruitment approaches in a primary care setting that serves patients from under-resourced communities. Patients will be English or Spanish speaking adults ≥18 years of age identified through the electronic health record (EHR) as having a primary care clinician at the participating practice as well as uncontrolled hypertension and suboptimal adherence to blood pressure medications based on pharmacy fill data linked to the electronic health record (EHR). The primary care clinicians of eligible patients identified through the EHR will have the opportunity 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 a preliminary study using prospect theory (versus the control letter), and (3) intensity of the intervention outreach (up to 4 calls vs. up to 2 calls). Patients across all arms who agree to be scheduled will receive an appointment with one of the clinical pharmacists trained in the brief negotiated interviewing approach used in the STIC2IT trial. The primary outcome will be completion of a clinical pharmacist appointment within 12 weeks of randomization. Key secondary outcomes will include scheduled visit rates, no-show rates for scheduled appointments, pharmacy fill adherence to statins and blood pressure medications over the 3-month follow-up, and clinical outcomes, including blood pressure as per EHR data in the 3 months after randomization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2024
CompletedFirst Posted
Study publicly available on registry
August 9, 2024
CompletedStudy Start
First participant enrolled
November 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
December 9, 2025
December 1, 2025
2.6 years
August 5, 2024
December 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants who completed an adherence counseling session
Measures patient attendance at a single adherence counseling session
12 weeks
Secondary Outcomes (5)
Number of participants who scheduled an adherence counseling session
12 weeks
Number of days that participants were adherent to blood pressure medication
12 weeks
Number of days that participants were adherent to statin medication
12 weeks
Systolic blood pressure
12 weeks
Diastolic blood pressure
12 weeks
Study Arms (8)
Postcard/behavioral letter/4 calls
ACTIVE COMPARATORMailed a priming postcard, followed by a prospect theory-informed recruitment letter, followed by up to 4 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing
No postcard/behavioral letter/4 calls
ACTIVE COMPARATORMailed a prospect-theory informed recruitment letter that is not preceded by a priming postcard, followed by up to 4 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing
Postcard/control letter/4 calls
ACTIVE COMPARATORMailed a priming postcard, followed by a usual care control recruitment letter, followed by up to 4 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing
No postcard/control letter/4 calls
ACTIVE COMPARATORMailed a usual care control recruitment letter that is not preceded by a priming postcard, followed by up to 4 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing
Postcard/behavioral letter/2 calls
ACTIVE COMPARATORMailed a priming postcard, followed by a prospect theory-informed recruitment letter, followed by up to 2 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing
No postcard/behavioral letter/2 calls
ACTIVE COMPARATORMailed a prospect theory-informed recruitment letter that is not preceded by a priming postcard, followed by up to 2 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing
Postcard/control letter/2 calls
ACTIVE COMPARATORMailed a priming postcard, followed by a usual care control recruitment letter, followed by up to 2 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing
No postcare/control letter/2 calls
ACTIVE COMPARATORMailed a usual care control recruitment letter that is not preceded by a priming postcard, followed by up to 2 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing
Interventions
Mailed recruitment letter with prospect-theory informed message framing
Up to 2 phone call attempts to schedule patient for a clinical pharmacist adherence counseling visit
Up to 4 phone call attempts to schedule patient for a clinical pharmacist adherence counseling visit
Mailed primer postcard
Mailed recruitment letter with usual care message framing
Eligibility Criteria
You may qualify if:
- Age 18 years or older
- Receive care at a Columbia-affiliated primary care clinic in the Ambulatory Care Network
- Diagnosis of hypertension
- Office BP \>=140/90 mmHg at most recent office visit
- Prescribed at least one blood pressure medication
- Nonadherent to at least one blood pressure medication as per pharmacy dispense records (proportion of days covered \<80% to at least one eligible medication in last 6 months)
You may not qualify if:
- Do not speak English or Spanish
- Pregnancy, dementia or terminal conditions as per ICD-10 codes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- National Institute on Aging (NIA)collaborator
- Brigham and Women's Hospitalcollaborator
Study Sites (1)
Columbia University Irving Medical Center
New York, New York, 10032, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- PIs 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 of Medicine
Study Record Dates
First Submitted
August 5, 2024
First Posted
August 9, 2024
Study Start
November 8, 2024
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
December 9, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- Within 1 year of completion of the trial
We plan to make available a de-identified database upon request