Engaging Patients in Adherence Interventions Using Behavioral Science

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT06543394
Status
Enrolling By Invitation

Conditions

  • Uncontrolled Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Primer postcard — BEHAVIORAL
    Mailed primer postcard
  • Control recruitment letter — BEHAVIORAL
    Mailed recruitment letter with usual care message framing
  • Behavioral theory-informed recruitment letter — BEHAVIORAL
    Mailed recruitment letter with prospect-theory informed message framing
  • 2 phone calls — BEHAVIORAL
    Up to 2 phone call attempts to schedule patient for a clinical pharmacist adherence counseling visit
  • 4 phone calls — BEHAVIORAL
    Up to 4 phone call attempts to schedule patient for a clinical pharmacist adherence counseling visit

Study Details

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.

Key Dates

Start date
Nov 8, 2024
Status verified
Dec 2025
Primary completion
Jun 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
584 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Postcard/behavioral letter/4 calls
    Mailed 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
  • Active Comparator: No postcard/behavioral letter/4 calls
    Mailed 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
  • Active Comparator: Postcard/control letter/4 calls
    Mailed 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
  • Active Comparator: No postcard/control letter/4 calls
    Mailed 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
  • Active Comparator: Postcard/behavioral letter/2 calls
    Mailed 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
  • Active Comparator: No postcard/behavioral letter/2 calls
    Mailed 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
  • Active Comparator: Postcard/control letter/2 calls
    Mailed 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
  • Active Comparator: No postcare/control letter/2 calls
    Mailed 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

Primary Outcome Measure

Number of participants who completed an adherence counseling session [ Time Frame: 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032-

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