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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01771536
First Posted: January 18, 2013
Last Update Posted: March 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nilay D. Shah, Mayo Clinic
  Purpose

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 Intervention
Stable Angina Other: Decision Aid

Study Type: Interventional
Study Design: Allocation: Randomized
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

Resource links provided by NLM:


Further study details as provided by Nilay D. Shah, Mayo Clinic:

Primary Outcome Measures:
  • 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.


Enrollment: 132
Study Start Date: November 2012
Study Completion Date: June 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PCI Choice decision
Decision Aid intervention is provided to clinician to share with patient
Other: Decision Aid
No Intervention: Usual Care

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55901
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Nilay Shah, PhD Mayo Clinic
  More Information

Responsible Party: Nilay D. Shah, PhD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01771536     History of Changes
Other Study ID Numbers: 12-004554
First Submitted: December 15, 2012
First Posted: January 18, 2013
Last Update Posted: March 21, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Angina, Stable
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms


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