Study Stopped
Enrollment was not feasible
Treatment Decisions for Multi-vessel CAD
1 other identifier
interventional
14
1 country
4
Brief Summary
This study is a multi-center randomized trial to evaluate the Multi-vessel Coronary Artery Disease Option Grid patient decision aid compared to usual care in patient reported decisional conflict, knowledge, and shared decision making.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable coronary-artery-disease
Started Sep 2015
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 20, 2015
CompletedFirst Submitted
Initial submission to the registry
November 9, 2015
CompletedFirst Posted
Study publicly available on registry
November 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2017
CompletedJune 27, 2018
June 1, 2018
1.6 years
November 9, 2015
June 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient Decisional Conflict
The Ottawa Decisional Conflict Scale is a validated measure of a patient's feeling of conflict with the decision making experience
Collected immediately following patient's Option Grid or usual care clinical discussion, usually within 15 minutes after finishing the discussion.
Secondary Outcomes (5)
CollaboRATE Score
Collected immediately following patient's Option Grid or usual care clinical discussion, usually within 15 minutes after finishing the discussion.
Treatment Knowledge
Collected immediately following patient's Option Grid or usual care clinical discussion, usually within 15 minutes after finishing the discussion.
Patient Experience
Within five days of the clinical discussion
Clinician Experience
Within five days of the clinical discussion
Treatment Received
Within 1 month of clinical discussion
Study Arms (2)
Option Grid
EXPERIMENTALPatients randomized to the Option Grid arm will receive the Multi-vessel Coronary Artery Disease Option Grid at the time of enrollment. The treating physician will then discuss the patient diagnosis and treatment choice reviewing the Option Grid within the conversation to facilitate patient understanding and shared decision making
Usual Care
OTHERPatients randomized to usual care will discuss the patient diagnosis and treatment options typical to the physician's routine care.
Interventions
The Multi-vessel Coronary Artery Disease Option Grid is a patient decision aid used during the clinical visit. It is one page and contains a table a patient's frequently asked questions and the respective information for each treatment strategy. The Multi-vessel Coronary Artery Disease Option Grid was developed using patient and provider feedback and has been field-tested in clinic by cardiologists and surgeons.
In usual care clinicians will discuss the patient diagnosis and treatment options typical to routine care for that clinician.
Eligibility Criteria
You may qualify if:
- Stable multi-vessel coronary artery disease diagnosed by coronary angiography defined as left main disease (\>50% stenosis) or multi-vessel coronary artery disease (\>70% stenosis in two or more coronary arteries)
- At relative equipoise for at least two potential treatment options, in which the treating cardiologist or surgeon has determined the treatments are anatomically feasible and safe.
You may not qualify if:
- Prior coronary artery bypass grafting
- Unable to read or write English
- Not cognitively able to participate in the Option Grid as determined by clinician
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Maine Medical Center
Portland, Maine, 04102, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Albany Medical Center
Albany, New York, 12208, United States
Albany Stratton VA Medical Center
Albany, New York, 12208, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth L Nichols, MS
The Dartmouth Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2015
First Posted
November 20, 2015
Study Start
September 20, 2015
Primary Completion
April 30, 2017
Study Completion
May 31, 2017
Last Updated
June 27, 2018
Record last verified: 2018-06