Evaluation of a Decision Support Tool

Study Overview
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Brief Summary
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Investigators will conduct a randomized trial with patients, through one-on-one interviews, to evaluate their understanding of and willingness to use a decision support tool and to determine if receiving and discussing the decision support tool improves the likelihood that a patient is adherent to a new antihypertensive medication.

Official Title
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Primary Medication Adherence Phase 2 Evaluation of a Decision Support Tool

Conditions
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Medication Adherence, Hypertension, Decision Making, Shared, Patient-Centered Outcomes Research

Intervention / Treatment
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* Behavioral: Control
* Behavioral: Interview Only
* Behavioral: Interview plus decision support tool


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: does not pick up a prescription for a new antihypertensive medication within 14 days as identified by CVS pharmacy, their retail pharmacy provider. High blood pressure diagnosis Exclusion Criteria: under age 25.

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Interview only<br>Patients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension. | Behavioral: Interview Only<br>* Patients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension.<br>|
| Placebo Comparator: Control<br>Control group patients will then be mailed an American Heart Association brochure regarding hypertension and a brief, 5-question, paper-based survey. These patients will be asked to review the brochure, complete the survey, and mail it back to the research team using a self-addressed stamped envelope. | Behavioral: Control<br>* Control group patients will then be mailed an American Heart Association brochure regarding hypertension and a brief, 5-question, paper-based survey.<br>|
| Experimental: Interview plus decision support tool<br>Patients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension, and to provide feedback regarding a new tool for helping patients learn more about their medications. Interview plus patients' index date for follow-up is the date of the scheduled interview. | Behavioral: Interview plus decision support tool<br>* Patients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension and to provide feedback regarding a new decision support tool for helping patients learn more about their medications.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of antihypertensive medication fills | The proportion of patients in each group who picked up a prescription for an antihypertensive medication in any class during the follow-up period. Investigators will calculate cumulative incidences among all patients, whether or not they successfully completed the interview or returned the paper-based survey (Intention to Treat) and among only those patients who did complete the interview or returned the paper-based survey (As Treated). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Interviews | One-on-one structured interviews will ask about participants' preferences, attitudes and beliefs regarding primary adherence and/or use of a decision support tool. | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient-centered outcomes research, Antihypertensive medications, One-on-one patient interviews, Randomized controlled trial, Primary medication adherence, Decision-support tool