Overview

This trial is active, not recruiting.

Conditions medication adherence, hypertension, decision making, shared, patient-centered outcomes research
Treatments control, interview only, interview plus decision support tool
Sponsor Brigham and Women's Hospital
Collaborator Patient Centered Outcome Research Institute
Start date February 2014
End date March 2015
Trial size 140 participants
Trial identifier NCT02060981, #2013P001295/BWH, 2014-P-00008959

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Active Comparator)
Patients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension.
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 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.
control
Control group patients will then be mailed an American Heart Association brochure regarding hypertension and a brief, 5-question, paper-based survey.
(Experimental)
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.
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.

Primary Outcomes

Measure
Cumulative incidence of antihypertensive medication fills
time frame: 6 months

Secondary Outcomes

Measure
Patient Interviews
time frame: 5 months

Eligibility Criteria

Male or female participants at least 25 years old.

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.

Additional Information

Official title Primary Medication Adherence Phase 2 Evaluation of a Decision Support Tool
Principal investigator Jennifer Polinski, Sc.D.
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.