Evaluation of a Decision Support Tool (PRIMA)

Mass General Brigham

Status: Unknown

Conditions: Hypertension; Medication Adherence; Decision Making, Shared; Patient-Centered Outcomes Research

Treatments: Behavioral: Interview Only; Behavioral: Control; Behavioral: Interview plus decision support tool

Study type: Interventional

Funder types: Other

Identifiers

NCT02060981

#2013P001295/BWH (Other Identifier)

2014-P-00008959

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 25+ years old

Volunteers: No 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

Exclusion criteria

• under age 25.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 3 patient groups, including a placebo group

Interview only

Active Comparator group

Description:

Patients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension.

Treatment:

Behavioral: Interview Only

Control

Placebo Comparator group

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.

Treatment:

Behavioral: Control

Interview plus decision support tool

Experimental group

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.

Treatment:

Behavioral: Interview plus decision support tool