Clinical trial NCT02611050: Treatment Decisions for Multi-vessel CAD
Official title: Treatment Decisions for Multi-vessel Coronary Artery Disease Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: patient decision aid
multi-vessel coronary artery disease
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Patient Decisional Conflict
timeFrame: Collected immediately following patient's Option Grid or usual care clinical discussion, usually within 15 minutes after finishing the discussion.
Secondary outcomes:
measure: CollaboRATE Score
timeFrame: Collected immediately following patient's Option Grid or usual care clinical discussion, usually within 15 minutes after finishing the discussion.
measure: Treatment Knowledge
timeFrame: Collected immediately following patient's Option Grid or usual care clinical discussion, usually within 15 minutes after finishing the discussion.
measure: Patient Experience
timeFrame: Within five days of the clinical discussion
measure: Clinician Experience
timeFrame: Within five days of the clinical discussion
measure: Treatment Received
timeFrame: Within 1 month of clinical discussion
Other outcomes:
Locations:
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Albany
country: United States
facility: Albany Stratton VA Medical Center
state: New York
Study officials:
affiliation: The Dartmouth Institute
name: Elizabeth L Nichols, MS
role: PRINCIPAL_INVESTIGATOR
References: