Comparative Effectiveness of Decision Aids for Stable Chest Discomfort
Randomized Trial Comparing Effectiveness of Two Patient Decision Aids for Stable Chest Discomfort
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable coronary-artery-disease
Started Jan 2016
Shorter than P25 for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 8, 2016
CompletedFirst Posted
Study publicly available on registry
January 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedResults Posted
Study results publicly available
August 29, 2017
CompletedAugust 29, 2017
August 1, 2017
5 months
January 8, 2016
April 4, 2017
August 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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 Arms (2)
Online decision aid
ACTIVE COMPARATORThis group will receive the access to an online decision aid that covers the main treatment options for stable chest discomfort.
Video decision aid
ACTIVE COMPARATORThis group will receive the DVD and booklet decision aid describing stable chest discomfort and the main treatment options including medical therapy and stents.
Interventions
The Healthwise online shared decision point for Stable Chest Discomfort
The Health Dialog DVD and booklet decision aid for Stable Chest Discomfort
Eligibility Criteria
You may qualify if:
- Adults 18 and older
- English speaking
- Current diagnosis of stable angina
- Ability to access online material and willing to provide an email address
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (3)
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.
PMID: 17387127BACKGROUNDRothberg 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.
PMID: 20820040BACKGROUNDHolmboe 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.
PMID: 11029677BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Karen Sepucha
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Karen R Sepucha, PhD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 8, 2016
First Posted
January 11, 2016
Study Start
January 1, 2016
Primary Completion
June 1, 2016
Study Completion
November 1, 2016
Last Updated
August 29, 2017
Results First Posted
August 29, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share