- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02060981
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
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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-
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.
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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.
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Control group patients will then be mailed an American Heart Association brochure regarding hypertension and a brief, 5-question, paper-based survey.
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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.
|
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).
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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
Collaborators
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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