PRIMA: Evaluation of a Decision Support Tool

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02060981

Collaborator

Patient-Centered Outcomes Research Institute (Other), Foundation for Informed Medical Decision Making (Other)

140

Enrollment

Location

Arms

13.9

Duration (Months)

10.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Medication Adherence Hypertension Decision Making, Shared Patient-Centered Outcomes Research	Behavioral: Control Behavioral: Interview Only Behavioral: Interview plus decision support tool	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Primary Medication Adherence Phase 2 Evaluation of a Decision Support Tool

Study Start Date :

Feb 1, 2014

Anticipated Primary Completion Date :

Mar 1, 2015

Anticipated Study Completion Date :

Apr 1, 2015

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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