Evaluation of a Decision Support Tool

Not Applicable

• Conditions: Decision Making, Shared; Hypertension; Medication Adherence; Patient-Centered Outcomes Research
• Interventions: Behavioral: Interview Only; Behavioral: Control; Behavioral: Interview plus decision support tool

• Registration Number: NCT02060981
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-10
• Study First Submitted QC: 2014-02-10
• Study First Posted: 2014-02-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-16
• Last Update Posted: 2015-02-18
• Primary Completion: 2015-03
• Study Completion: 2015-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interview only	Interview Only	Patients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension.
Control	Control	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.
Interview plus decision support tool	Interview plus decision support tool	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.

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of antihypertensive medication fills	6 months	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States