An interventional study of Primer postcard and Control recruitment letter in Uncontrolled Hypertension, sponsored by Columbia University. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-09.
Sponsored by Columbia University · Not applicable, Interventional, and Health services research
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.
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.
223 studies on the registry are indexed under Medication Adherence; 108 are open to participants now.
This study's planned enrollment of 584 is above the median of 118 across 189 interventional studies indexed under Medication Adherence.
Browse Medication Adherence studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Behavioral: Primer postcard · Behavioral: Behavioral theory-informed recruitment letter · Behavioral: 4 phone 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
Behavioral: Behavioral theory-informed recruitment letter · Behavioral: 4 phone 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
Behavioral: Primer postcard · Behavioral: Control recruitment letter · Behavioral: 4 phone 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
Behavioral: Control recruitment letter · Behavioral: 4 phone 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
Behavioral: Primer postcard · Behavioral: Behavioral theory-informed recruitment letter · Behavioral: 2 phone 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
Behavioral: Behavioral theory-informed recruitment letter · Behavioral: 2 phone 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
Behavioral: Primer postcard · Behavioral: Control recruitment letter · Behavioral: 2 phone 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
Behavioral: Control recruitment letter · Behavioral: 2 phone calls
Mailed primer postcard
Mailed recruitment letter with usual care message framing
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
Number of participants who completed an adherence counseling session
Measures patient attendance at a single adherence counseling session
Time frame: 12 weeks
Number of participants who scheduled an adherence counseling session
Patient scheduled an adherence counseling session
Time frame: 12 weeks
Number of days that participants were adherent to blood pressure medication
Number of days covered for blood pressure medications \>= 80%
Time frame: 12 weeks
Number of days that participants were adherent to statin medication
Number of days covered for statin medications \>= 80%
Time frame: 12 weeks
Systolic blood pressure
Systolic blood pressure at office visit
Time frame: 12 weeks
Diastolic blood pressure
Diastolic blood pressure at office visit
Time frame: 12 weeks
Plan to share: Yes — We plan to make available a de-identified database upon request
Supporting information: Study protocol, Sap, Analytic code
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