Treatment Decisions for Multi-vessel CAD

Coronary Artery Disease Clinical Trial

Official title:

Treatment Decisions for Multi-vessel Coronary Artery Disease Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02611050
• Other study ID #: 00028467
• Status: Terminated
• Phase: N/A
• Start date: September 20, 2015
• Est. completion date: May 31, 2017

Study information

• Verified date: June 2018
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: May 31, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Behavioral:
• The Multi-vessel Coronary Artery Disease Option Grid
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.
• Usual Care
In usual care clinicians will discuss the patient diagnosis and treatment options typical to routine care for that clinician.

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York
United States	Albany Stratton VA Medical Center	Albany	New York
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Maine Medical Center	Portland	Maine

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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