Clinical trial NCT02652208: 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
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Stable Angina
Keywords: decision making
decision aids
shared decision making
stable angina
cardiology
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2016-01-11
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Total Knowledge Score
timeFrame: Within 1 week after reviewing the decision aid
Secondary outcomes:
measure: Treatment Leaning (Percentage of Patients Who Have a Clear Treatment Preference)
timeFrame: Within 1 week after reviewing the decision aid
measure: Satisfaction With the Intervention
timeFrame: Within 1 week after reviewing the decision aid
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Karen R Sepucha, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.