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The PCI Choice Trial: a Pilot Randomized Trial of a Decision Aid for Patients With Stable Coronary Artery Disease

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Mayo Clinic

Status

Completed

Conditions

Stable Angina

Treatments

Other: Decision Aid

Study type

Interventional

Funder types

Other

Identifiers

NCT01771536
12-004554

Details and patient eligibility

About

Despite several large clinical trials clearly establishing that coronary revascularization (i.e. percutaneous coronary intervention - PCI) does not prolong survival or prevent myocardial infarction (MI) for stable coronary artery disease (CAD), patients with stable angina continue to believe that PCI is performed to improve these outcomes. Additionally, recent concerns have emerged of overuse of PCI among patients with little or no angina. Thus there is a compelling need to share with patients the risks and benefits of PCI prior to treatment to reach an informed decision.

This study is designed to answer the question of whether a decision aid can improve patient knowledge, decisional conflict and patient satisfaction with decision-making compared to usual care for the treatment of stable angina.

Enrollment

132 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of stable angina - As judge by clinician, eligible for medication therapy or PCI - agree to be available for follow-up survey 3 months after treatment decision

Exclusion criteria

  • has major communication barrier (severe hearing/vision impairment, dementia, cannot communicate with clinician in English)

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

132 participants in 2 patient groups

PCI Choice decision
Active Comparator group
Description:
Decision Aid intervention is provided to clinician to share with patient
Treatment:
Other: Decision Aid
Usual Care
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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