Columbia University
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…
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
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