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Treatment Decisions for Multi-vessel CAD

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Multi-vessel Coronary Artery Disease Option Grid
Usual Care
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Coronary Artery Disease focused on measuring patient decision aid, multi-vessel coronary artery disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Prior coronary artery bypass grafting
  • Unable to read or write English
  • Not cognitively able to participate in the Option Grid as determined by clinician

Sites / Locations

  • Maine Medical Center
  • Dartmouth-Hitchcock Medical Center
  • Albany Medical Center
  • Albany Stratton VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Option Grid

Usual Care

Arm Description

Patients 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

Patients randomized to usual care will discuss the patient diagnosis and treatment options typical to the physician's routine care.

Outcomes

Primary Outcome Measures

Patient Decisional Conflict
The Ottawa Decisional Conflict Scale is a validated measure of a patient's feeling of conflict with the decision making experience

Secondary Outcome Measures

CollaboRATE Score
CollaboRATE is a patient reported measure of shared decision making
Treatment Knowledge
Questions about multi-vessel coronary artery disease treatment knowledge. Response options are 'true/false/unsure.' Scores will be based off of the percentage of correct responses from 0 to 100
Patient Experience
Patient's qualitative feedback during semi-structured interviews about their decision making experience
Clinician Experience
Clinician's qualitative feedback during semi-structured interviews about their decision making experience
Treatment Received
Identified through medical records or registry data

Full Information

First Posted
November 9, 2015
Last Updated
June 25, 2018
Sponsor
Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02611050
Brief Title
Treatment Decisions for Multi-vessel CAD
Official Title
Treatment Decisions for Multi-vessel Coronary Artery Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
Enrollment was not feasible
Study Start Date
September 20, 2015 (Actual)
Primary Completion Date
April 30, 2017 (Actual)
Study Completion Date
May 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Multi-vessel coronary artery disease can be treated through percutaneous coronary intervention, coronary artery bypass grafting, or medical therapy. Treatments have risk benefit tradeoffs, making patient preference integral to the treatment decision. The Multi-vessel Coronary Artery Disease Option Grid patient decision aid was developed to improve the decision making process for patients and clinicians. Objectives: Evaluate The Multi-vessel Coronary Artery Disease Option Grid impact on patient treatment decisional conflict, knowledge, and shared decision making. The randomized controlled trial will compare validated and standardized measures of patient decisional conflict, shared decision making, and condition specific treatment knowledge between Option Grid and usual care patients. The investigators hypothesize Option Grid patients will have improvements in patient decisional conflict, shared decision making, and knowledge compared to usual care patients. Baseline feasibility enrollment at each site prior to randomization will be used to identify current treatment patterns, and prepare intervention delivery and fidelity. Registry data will be used to identify patient treatment received and compared between Option Grid and usual care arms. Examine the physician and patient process of and factors influencing Multi-vessel Coronary Artery Disease Option Grid use. Semi-structured interviews and process evaluations will be used to describe Option Grid use and experience and identify factors that are associated with beneficial Option Grid use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
patient decision aid, multi-vessel coronary artery disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Option Grid
Arm Type
Experimental
Arm Description
Patients 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
Arm Title
Usual Care
Arm Type
Other
Arm Description
Patients randomized to usual care will discuss the patient diagnosis and treatment options typical to the physician's routine care.
Intervention Type
Behavioral
Intervention Name(s)
The Multi-vessel Coronary Artery Disease Option Grid
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
In usual care clinicians will discuss the patient diagnosis and treatment options typical to routine care for that clinician.
Primary Outcome Measure Information:
Title
Patient Decisional Conflict
Description
The Ottawa Decisional Conflict Scale is a validated measure of a patient's feeling of conflict with the decision making experience
Time Frame
Collected immediately following patient's Option Grid or usual care clinical discussion, usually within 15 minutes after finishing the discussion.
Secondary Outcome Measure Information:
Title
CollaboRATE Score
Description
CollaboRATE is a patient reported measure of shared decision making
Time Frame
Collected immediately following patient's Option Grid or usual care clinical discussion, usually within 15 minutes after finishing the discussion.
Title
Treatment Knowledge
Description
Questions about multi-vessel coronary artery disease treatment knowledge. Response options are 'true/false/unsure.' Scores will be based off of the percentage of correct responses from 0 to 100
Time Frame
Collected immediately following patient's Option Grid or usual care clinical discussion, usually within 15 minutes after finishing the discussion.
Title
Patient Experience
Description
Patient's qualitative feedback during semi-structured interviews about their decision making experience
Time Frame
Within five days of the clinical discussion
Title
Clinician Experience
Description
Clinician's qualitative feedback during semi-structured interviews about their decision making experience
Time Frame
Within five days of the clinical discussion
Title
Treatment Received
Description
Identified through medical records or registry data
Time Frame
Within 1 month of clinical discussion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Prior coronary artery bypass grafting Unable to read or write English Not cognitively able to participate in the Option Grid as determined by clinician
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth L Nichols, MS
Organizational Affiliation
The Dartmouth Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Albany Stratton VA Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States

12. IPD Sharing Statement

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Treatment Decisions for Multi-vessel CAD

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