The PCI Choice Trial: a Pilot Randomized Trial of a Decision Aid for Patients With Stable Coronary Artery Disease
1 other identifier
interventional
132
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 15, 2012
CompletedFirst Posted
Study publicly available on registry
January 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedMarch 15, 2023
March 1, 2023
1.3 years
December 15, 2012
March 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy of the PCI Choice Decision aid vs. Usual Care assessed by Patient and Provider Surveys, and encounter Video/Audio Recordings
Efficacy in improving measures of patient knowledge and involvement, decision making quality, treatment choice and clinician satisfaction of the decision aid.
Baseline to Three Months
Study Arms (2)
PCI Choice decision
ACTIVE COMPARATORDecision Aid intervention is provided to clinician to share with patient
Usual Care
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- has major communication barrier (severe hearing/vision impairment, dementia, cannot communicate with clinician in English)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55901, United States
Related Publications (1)
Coylewright M, Dick S, Zmolek B, Askelin J, Hawkins E, Branda M, Inselman JW, Zeballos-Palacios C, Shah ND, Hess EP, LeBlanc A, Montori VM, Ting HH. PCI Choice Decision Aid for Stable Coronary Artery Disease: A Randomized Trial. Circ Cardiovasc Qual Outcomes. 2016 Nov;9(6):767-776. doi: 10.1161/CIRCOUTCOMES.116.002641. Epub 2016 Nov 1.
PMID: 27803090DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nilay Shah, PhD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2012
First Posted
January 18, 2013
Study Start
November 1, 2012
Primary Completion
March 1, 2014
Study Completion
June 1, 2014
Last Updated
March 15, 2023
Record last verified: 2023-03