Treatment Decisions for Multi-vessel CAD

NCT ID: NCT02611050

Last Updated: 2018-06-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-20
• Study Completion Date: 2017-05-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

The Multi-vessel Coronary Artery Disease Option Grid

Intervention Type: BEHAVIORAL

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

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

Group Type: OTHER

Usual Care

Intervention Type: BEHAVIORAL

In usual care clinicians will discuss the patient diagnosis and treatment options typical to routine care for that clinician.

Interventions

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.

Intervention Type: BEHAVIORAL

Usual Care

In usual care clinicians will discuss the patient diagnosis and treatment options typical to routine care for that clinician.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth L Nichols, MS

Role: PRINCIPAL_INVESTIGATOR

The Dartmouth Institute

Locations

Maine Medical Center

Portland, Maine, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Albany Medical Center

Albany, New York, United States

Albany Stratton VA Medical Center

Albany, New York, United States

Countries

United States

Other Identifiers

00028467

Identifier Type: -

Identifier Source: org_study_id