Coronary Artery Disease Clinical Trial
Official title:
Randomized Trial Comparing Effectiveness of Two Patient Decision Aids for Stable Chest Discomfort
Verified date | August 2017 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 34 |
Est. completion date | November 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
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. Epub 2007 Mar 26. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | Within 1 week after reviewing the decision aid | |
Secondary | Satisfaction With the Intervention | Number of respondents who rated the material as "very good" or "excellent". | Within 1 week after reviewing the decision aid |
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