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OpenTrials
Completed

NCT Number: NCT02652208

Comparative Effectiveness of Decision Aids for Stable Chest Discomfort

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.

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Key information

Conditions

Coronary Artery Disease Angina Pectoris Angina, Stable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Disease Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stable Angina Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Online decision aid

Behavioral

The Healthwise online shared decision point for Stable Chest Discomfort

video decision aid

Behavioral

The Health Dialog DVD and booklet decision aid for Stable Chest Discomfort

Primary outcomes

  1. 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

  1. Treatment Leaning (Percentage of Patients Who Have a Clear Treatment Preference)

    Time frame: Within 1 week after reviewing the decision aid

    To determine the percentage of patients who have a clear treatment preference for their stable chest discomfort.

  2. Satisfaction With the Intervention

    Time frame: Within 1 week after reviewing the decision aid

    Number of respondents who rated the material as "very good" or "excellent".

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 11, 2016
Registry last updated
Aug 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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