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Clinical Trials/NCT02652208
NCT02652208
Completed
Not Applicable

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

Massachusetts General Hospital1 site in 1 country34 target enrollmentJanuary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Massachusetts General Hospital
Enrollment
34
Locations
1
Primary Endpoint
Total Knowledge Score
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
November 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Karen Sepucha

Assistant Professor

Massachusetts General Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Total Knowledge Score

Time Frame: Within 1 week after reviewing the decision aid

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.

Secondary Outcomes

  • Treatment Leaning (Percentage of Patients Who Have a Clear Treatment Preference)(Within 1 week after reviewing the decision aid)
  • Satisfaction With the Intervention(Within 1 week after reviewing the decision aid)

Study Sites (1)

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