Clinical trial NCT06543394: Engaging Patients in Adherence Interventions Using Behavioral Science
Official title: Optimizing Recruitment Methodology for Medication Adherence Interventions: The ENGaging Patients in Adherence Interventions UsinG Behavioral SciencE (ENGAGE) Randomized Factorial Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Uncontrolled Hypertension
Keywords: medication adherence
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Brigham and Women's Hospital
First posted: 2024-08-09
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 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.

Detailed description: Participants will be recruited from Columbia University Irving Medical Center (CUIMC)-affiliated primary care clinics that are part of the New York Presbyterian (NYP) Ambulatory Care Network (ACN). These clinics provide care to patients in the catchment area of CUIMC which is notable for substantial racial, ethnic, and economic diversity. The study team will identify participants with uncontrolled hypertension (last office BP \<140/90 mmHg) who also are nonadherent (PDC\<80%) to at least one antihypertensive medication class and meet other study eligibility criteria.

Participants will then be randomized using a 2\^3 factorial approach to each of the following conditions, such that there will be 8 total arms: (1) inclusion of a mailer primer (yes vs no), (2) a behavioral theory-informed letter script (vs usual scripted letter), and (3) intensity of the recruitment outreach (up to 4 calls vs up to 2 calls). Recruitment outreach will be conducted by members of the study team, who will be trained to deliver different interventions based on a patient's assigned arm. Enrollment will be staggered over an approximately 4-month period so as not to overwhelm the scheduling staff and mimic how quality improvement programs are conducted in typical practice.

Participants who agree to participate in the adherence counseling session after receiving any of the 8 combinations of recruitment strategies will be scheduled to receive a brief evidence-based medication adherence counseling session known as brief negotiated interviewing. Patients who schedule a counseling session with a clinical pharmacist will receive a reminder call before their appointment. This will involve a 30-minute or less telephone or video visit with a nurse or clinical pharmacist who will use a semi-structured guide to confirm the patient's treatment regimen, engage them in sharing potential barriers to adherence or other factors that may be contributing to poor disease control, discuss their readiness to modify behaviors, and work with the patient to develop a shared plan.

The study will concurrently test whether 1) inclusion of a mailed primer is better than no inclusion, 2) whether use of a behavioral theory-informed message-framing strategy in the recruitment letter is better than the usual approach that does not include theory-informed message framing in a recruitment letter, and 3) whether increasing the intensity of recruitment outreach after the letter through up to 4 phone calls is better than up to 2 phone calls. The primary outcome for the study will be whether or not patients completed the adherence counseling session within 12 weeks of randomization. The secondary outcome will be whether patients agreed to have the counseling session scheduled. Exploratory outcomes will include the effects on medication adherence, blood pressure, and LDL cholesterol 3 months after randomization.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* Do not speak English or Spanish
* Pregnancy, dementia or terminal conditions as per ICD-10 codes

Primary outcomes:
measure: Number of participants who completed an adherence counseling session
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of participants who scheduled an adherence counseling session
timeFrame: 12 weeks
measure: Number of days that participants were adherent to blood pressure medication
timeFrame: 12 weeks
measure: Number of days that participants were adherent to statin medication
timeFrame: 12 weeks
measure: Systolic blood pressure
timeFrame: 12 weeks
measure: Diastolic blood pressure
timeFrame: 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
References: