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NCT02060981 Clinical Trial

Evaluation of a Decision Support Tool

Hypertension Clinical Trial

— PRIMA  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02060981
Other study ID # 2014-P-00008959
Secondary ID #2013P001295/BWH
Status Active, not recruiting
Phase N/A
First received February 10, 2014
Last updated February 16, 2015
Start date February 2014
Est. completion date April 2015

Study information
Verified date February 2015
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 140
Est. completion date April 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 25 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Intervention

Behavioral:
• Control
Control group patients will then be mailed an American Heart Association brochure regarding hypertension and a brief, 5-question, paper-based survey.
• Interview Only
Patients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension.
• 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 decision support tool for helping patients learn more about their medications.

Locations
Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (3)
Lead Sponsor Collaborator
Brigham and Women's Hospital Foundation for Informed Medical Decision Making, Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
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