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Comparative Effectiveness of Decision Aids for Stable Chest Discomfort

Primary Purpose

Coronary Artery Disease, Stable Angina

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online decision aid
Video decision aid
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Coronary Artery Disease focused on measuring decision making, decision aids, shared decision making, stable angina, cardiology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Online decision aid

Video decision aid

Arm Description

This group will receive the access to an online decision aid that covers the main treatment options for stable chest discomfort.

This group will receive the DVD and booklet decision aid describing stable chest discomfort and the main treatment options including medical therapy and stents.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 8, 2016
Last Updated
August 28, 2017
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02652208
Brief Title
Comparative Effectiveness of Decision Aids for Stable Chest Discomfort
Official Title
Randomized Trial Comparing Effectiveness of Two Patient Decision Aids for Stable Chest Discomfort
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Stable Angina
Keywords
decision making, decision aids, shared decision making, stable angina, cardiology

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Online decision aid
Arm Type
Active Comparator
Arm Description
This group will receive the access to an online decision aid that covers the main treatment options for stable chest discomfort.
Arm Title
Video decision aid
Arm Type
Active Comparator
Arm Description
This group will receive the DVD and booklet decision aid describing stable chest discomfort and the main treatment options including medical therapy and stents.
Intervention Type
Behavioral
Intervention Name(s)
Online decision aid
Intervention Description
The Healthwise online shared decision point for Stable Chest Discomfort
Intervention Type
Behavioral
Intervention Name(s)
Video decision aid
Intervention Description
The Health Dialog DVD and booklet decision aid for Stable Chest Discomfort
Primary Outcome Measure Information:
Title
Total Knowledge Score
Description
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.
Time Frame
Within 1 week after reviewing the decision aid
Secondary Outcome Measure Information:
Title
Treatment Leaning (Percentage of Patients Who Have a Clear Treatment Preference)
Description
To determine the percentage of patients who have a clear treatment preference for their stable chest discomfort.
Time Frame
Within 1 week after reviewing the decision aid
Title
Satisfaction With the Intervention
Description
Number of respondents who rated the material as "very good" or "excellent".
Time Frame
Within 1 week after reviewing the decision aid

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen R Sepucha, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17387127
Citation
Boden WE, O'Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ, Knudtson M, Dada M, Casperson P, Harris CL, Chaitman BR, Shaw L, Gosselin G, Nawaz S, Title LM, Gau G, Blaustein AS, Booth DC, Bates ER, Spertus JA, Berman DS, Mancini GB, Weintraub WS; COURAGE Trial Research Group. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007 Apr 12;356(15):1503-16. doi: 10.1056/NEJMoa070829. Epub 2007 Mar 26.
Results Reference
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PubMed Identifier
20820040
Citation
Rothberg MB, Sivalingam SK, Ashraf J, Visintainer P, Joelson J, Kleppel R, Vallurupalli N, Schweiger MJ. Patients' and cardiologists' perceptions of the benefits of percutaneous coronary intervention for stable coronary disease. Ann Intern Med. 2010 Sep 7;153(5):307-13. doi: 10.7326/0003-4819-153-5-201009070-00005.
Results Reference
background
PubMed Identifier
11029677
Citation
Holmboe ES, Fiellin DA, Cusanelli E, Remetz M, Krumholz HM. Perceptions of benefit and risk of patients undergoing first-time elective percutaneous coronary revascularization. J Gen Intern Med. 2000 Sep;15(9):632-7. doi: 10.1046/j.1525-1497.2000.90823.x.
Results Reference
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Comparative Effectiveness of Decision Aids for Stable Chest Discomfort

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