Treatment Decisions for Multi-vessel CAD

Treatment Decisions for Multi-vessel Coronary Artery Disease Patients

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Behavioral: The Multi-vessel Coronary Artery Disease Option Grid; Behavioral: Usual Care

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • Albany, New York, United States, 12208
      • Albany Stratton VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.
Other: Usual Care; Patients randomized to usual care will discuss the patient diagnosis and treatment options typical to the physician's routine care.	Behavioral: Usual Care; In usual care clinicians will discuss the patient diagnosis and treatment options typical to routine care for that clinician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
Patient Experience	Patient's qualitative feedback during semi-structured interviews about their decision making experience	Within five days of the clinical discussion
Clinician Experience	Clinician's qualitative feedback during semi-structured interviews about their decision making experience	Within five days of the clinical discussion
Treatment Received	Identified through medical records or registry data	Within 1 month of clinical discussion

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Investigators: Principal Investigator: Elizabeth L Nichols, MS, The Dartmouth Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2015
• Primary Completion (Actual): April 30, 2017
• Study Completion (Actual): May 31, 2017

Study Registration Dates

• First Submitted: November 9, 2015
• First Submitted That Met QC Criteria: November 18, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Actual): June 27, 2018
• Last Update Submitted That Met QC Criteria: June 25, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: patient decision aid; multi-vessel coronary artery disease
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 00028467