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Evaluation of a Decision Support Tool

Primary Medication Adherence Phase 2 Evaluation of a Decision Support Tool

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02060981
Acronym
PRIMA
Enrollment
140
Registered
2014-02-12
Start date
2014-02-28
Completion date
2015-04-30
Last updated
2015-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decision Making, Shared, Hypertension, Medication Adherence, 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

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.

Interventions

BEHAVIORALControl

Control group patients will then be mailed an American Heart Association brochure regarding hypertension and a brief, 5-question, paper-based survey.

BEHAVIORALInterview Only

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

BEHAVIORALInterview 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.

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
Foundation for Informed Medical Decision Making
CollaboratorOTHER
Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cumulative incidence of antihypertensive medication fills6 monthsThe 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

MeasureTime frameDescription
Patient Interviews5 monthsOne-on-one structured interviews will ask about participants' preferences, attitudes and beliefs regarding primary adherence and/or use of a decision support tool.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026