Treatment Decisions for Multi-vessel CAD

Not Applicable

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Behavioral: Usual Care; Behavioral: The Multi-vessel Coronary Artery Disease Option Grid

• Registration Number: NCT02611050
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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:

1. 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.

2. 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.

Study Timeline

• Study Start: 2015-09-20
• Study First Submitted: 2015-11-09
• Study First Submitted QC: 2015-11-18
• Study First Posted: 2015-11-20
• Primary Completion: 2017-04-30
• Study Completion: 2017-05-31
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-25
• Last Update Posted: 2018-06-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	Patients randomized to usual care will discuss the patient diagnosis and treatment options typical to the physician's routine care.
Option Grid	The Multi-vessel Coronary Artery Disease Option Grid	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

Primary Outcome Measures

Name	Time	Method
Patient Decisional Conflict	Collected immediately following patient's Option Grid or usual care clinical discussion, usually within 15 minutes after finishing the discussion.	The Ottawa Decisional Conflict Scale is a validated measure of a patient's feeling of conflict with the decision making experience

Secondary Outcome Measures

Name	Time	Method
Patient Experience	Within five days of the clinical discussion	Patient's qualitative feedback during semi-structured interviews about their decision making experience
Treatment Received	Within 1 month of clinical discussion	Identified through medical records or registry data
Treatment Knowledge	Collected immediately following patient's Option Grid or usual care clinical discussion, usually within 15 minutes after finishing the discussion.	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
CollaboRATE Score	Collected immediately following patient's Option Grid or usual care clinical discussion, usually within 15 minutes after finishing the discussion.	CollaboRATE is a patient reported measure of shared decision making
Clinician Experience	Within five days of the clinical discussion	Clinician's qualitative feedback during semi-structured interviews about their decision making experience

Trial Locations

Locations (4)

Maine Medical Center; 🇺🇸 Portland, Maine, United States

Albany Medical Center; 🇺🇸 Albany, New York, United States

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

Albany Stratton VA Medical Center; 🇺🇸 Albany, New York, United States