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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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nilay D. Shah, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01771536
First received: December 15, 2012
Last updated: November 14, 2014
Last verified: November 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]
    Efficacy in improving measures of patient knowledge and involvement, decision making quality, treatment choice and clinician satisfaction of the DA


Secondary Outcome Measures:
  • Number of Subjects adherent to medications assessed by patient follow-up surveys and Pharmacy prescription profiles. [ Time Frame: Baseline to six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: November 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Nilay D. Shah, PhD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01771536     History of Changes
Other Study ID Numbers: 12-004554
Study First Received: December 15, 2012
Last Updated: November 14, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 24, 2014