Comparative Effectiveness of Decision Aids for Stable Chest Discomfort

August 28, 2017 updated by: Karen Sepucha, Massachusetts General Hospital

Randomized Trial Comparing Effectiveness of Two Patient 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Online decision aid
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
The Healthwise online shared decision point for Stable Chest Discomfort
Active Comparator: Video decision aid
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
The Health Dialog DVD and booklet decision aid for Stable Chest Discomfort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
Within 1 week after reviewing the decision aid
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".
Within 1 week after reviewing the decision aid

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

January 8, 2016

First Submitted That Met QC Criteria

January 8, 2016

First Posted (Estimate)

January 11, 2016

Study Record Updates

Last Update Posted (Actual)

August 29, 2017

Last Update Submitted That Met QC Criteria

August 28, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014P002292

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on Online decision aid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe