Back to resultsEvaluation of a Decision Support Tool (PRIMA)
Primary Purpose
Medication Adherence, Hypertension, Decision Making, Shared
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control
Interview Only
Interview plus decision support tool
Sponsored by
About this trial
This is an interventional health services research trial for Medication Adherence focused on measuring Randomized controlled trial, Primary medication adherence, Decision-support tool, Patient-centered outcomes research, Antihypertensive medications, One-on-one patient interviews
Eligibility Criteria
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.
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Experimental
Arm Label
Interview only
Control
Interview plus decision support tool
Arm Description
Patients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension.
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02060981
First Posted
February 10, 2014
Last Updated
February 16, 2015
Sponsor
Brigham and Women's Hospital
Collaborators
Patient-Centered Outcomes Research Institute, Foundation for Informed Medical Decision Making
1. Study Identification
Unique Protocol Identification Number
NCT02060981
Brief Title
Evaluation of a Decision Support Tool
Acronym
PRIMA
Official Title
Primary Medication Adherence Phase 2 Evaluation of a Decision Support Tool
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
April 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Patient-Centered Outcomes Research Institute, Foundation for Informed Medical Decision Making
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Adherence, Hypertension, Decision Making, Shared, Patient-Centered Outcomes Research
Keywords
Randomized controlled trial, Primary medication adherence, Decision-support tool, Patient-centered outcomes research, Antihypertensive medications, One-on-one patient interviews
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interview only
Arm Type
Active Comparator
Arm Description
Patients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Interview plus decision support tool
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Control group patients will then be mailed an American Heart Association brochure regarding hypertension and a brief, 5-question, paper-based survey.
Intervention Type
Behavioral
Intervention Name(s)
Interview Only
Intervention Description
Patients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension.
Intervention Type
Behavioral
Intervention Name(s)
Interview plus decision support tool
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cumulative incidence of antihypertensive medication fills
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Patient Interviews
Description
One-on-one structured interviews will ask about participants' preferences, attitudes and beliefs regarding primary adherence and/or use of a decision support tool.
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Polinski, Sc.D.
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of a Decision Support Tool
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