Comparative Effectiveness of Decision Aids for Stable Chest Discomfort

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02652208
• Other study ID #: 2014P002292
• Status: Completed
• Phase: N/A
• First received: January 8, 2016
• Last updated: August 28, 2017
• Start date: January 2016
• Est. completion date: November 2016

Study information

• Verified date: August 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Angina, Stable
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Stable Angina

Intervention

Behavioral:
• Online decision aid
The Healthwise online shared decision point for Stable Chest Discomfort
• Video decision aid
The Health Dialog DVD and booklet decision aid for Stable Chest Discomfort

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & 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. 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

Outcome

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