Evaluation of a Decision Support Tool (PRIMA)

February 16, 2015 updated by: Jennifer Polinski, Brigham and Women's Hospital

Primary Medication Adherence Phase 2 Evaluation of a Decision Support Tool

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Interview only
Patients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension.
Behavioral: Interview Only
Patients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension.
Placebo Comparator: 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.
Behavioral: Control
Control group patients will then be mailed an American Heart Association brochure regarding hypertension and a brief, 5-question, paper-based survey.
Experimental: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of antihypertensive medication fills
Time Frame: 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).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Interviews
Time Frame: 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.
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

Patient-Centered Outcomes Research Institute
Foundation for Informed Medical Decision Making

Investigators

  • Principal Investigator: Jennifer Polinski, Sc.D., Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

March 1, 2015

Study Completion (Anticipated)

April 1, 2015

Study Registration Dates

First Submitted

February 10, 2014

First Submitted That Met QC Criteria

February 10, 2014

First Posted (Estimate)

February 12, 2014

Study Record Updates

Last Update Posted (Estimate)

February 18, 2015

Last Update Submitted That Met QC Criteria

February 16, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-P-00008959
  • #2013P001295/BWH (Other Identifier: Partners IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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