The PCI Choice Trial: a Pilot Randomized Trial of a Decision Aid for Patients With Stable Coronary Artery Disease
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|ClinicalTrials.gov Identifier: NCT01771536|
Recruitment Status : Completed
First Posted : January 18, 2013
Last Update Posted : March 21, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Stable Angina||Other: Decision Aid||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||132 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||The PCI Choice Trial: a Pilot Randomized Trial of a Decision Aid for Patients With Stable Coronary Artery Disease|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||June 2014|
Active Comparator: PCI Choice decision
Decision Aid intervention is provided to clinician to share with patient
|Other: Decision Aid|
|No Intervention: Usual Care|
- Efficacy of the PCI Choice Decision aid vs. Usual Care assessed by Patient and Provider Surveys, and encounter Video/Audio Recordings [ Time Frame: Baseline to Three Months ]Efficacy in improving measures of patient knowledge and involvement, decision making quality, treatment choice and clinician satisfaction of the decision aid.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771536
|United States, Minnesota|
|Rochester, Minnesota, United States, 55901|
|Principal Investigator:||Nilay Shah, PhD||Mayo Clinic|