Comparative Effectiveness of Decision Aids for Stable Chest Discomfort

Study Overview
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Brief Summary
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The purpose of the study is to compare two different types of decision support materials for patients considering treatment for chest pain or chest discomfort from heart disease.

Detailed Description
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The purpose of the project is to compare the effectiveness of a detailed, video patient decision aid and an online, interactive patient decision aid for treatment of Stable Chest Discomfort. The study will randomly assign eligible participants to receive either the online decision aid or the video decision aid. Participants will complete a survey after reviewing the decision aid that will examine decision quality, use of the intervention, and satisfaction with the intervention.

Official Title
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Randomized Trial Comparing Effectiveness of Two Patient Decision Aids for Stable Chest Discomfort

Conditions
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Coronary Artery Disease, Stable Angina

Intervention / Treatment
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* Behavioral: Online decision aid
* Behavioral: Video decision aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 18 and older English speaking Current diagnosis of stable angina Ability to access online material and willing to provide an email address Exclusion Criteria: Coronary bypass surgery and/or percutaneous coronary intervention within 6 months Diagnosis of unstable angina, acute coronary syndrome, STEMI, non STEMI within 6 months Scheduled for nonelective catheterization Significant cognitive deficit such that participant is unable to consent for self Serious comorbidities or other conditions that make revascularization inappropriate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Online decision aid<br>This group will receive the access to an online decision aid that covers the main treatment options for stable chest discomfort. | Behavioral: Online decision aid<br>* The Healthwise online shared decision point for Stable Chest Discomfort<br>|
| Active Comparator: Video decision aid<br>This group will receive the DVD and booklet decision aid describing stable chest discomfort and the main treatment options including medical therapy and stents. | Behavioral: Video decision aid<br>* The Health Dialog DVD and booklet decision aid for Stable Chest Discomfort<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Knowledge Score | Six multiple choice knowledge items covered important facts patients should know about chest pain or discomfort and treatments. A total knowledge score (0-6) was created by summing the total number of correct responses. A missing knowledge response was marked as incorrect. Any survey with more than three missing knowledge responses did not get a total knowledge score. A higher score indicates higher knowledge on the topic. Both decision aids provided information for answering all knowledge items. Higher knowledge scores are better. | Within 1 week after reviewing the decision aid | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Leaning (Percentage of Patients Who Have a Clear Treatment Preference) | To determine the percentage of patients who have a clear treatment preference for their stable chest discomfort. | Within 1 week after reviewing the decision aid | 
| Satisfaction With the Intervention | Number of respondents who rated the material as very good or excellent. | Within 1 week after reviewing the decision aid | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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decision making, decision aids, shared decision making, stable angina, cardiology