Comparative Effectiveness of Decision Aids for Stable Chest Discomfort

NCT ID: NCT02652208

Last Updated: 2017-08-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-11-30

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease Stable Angina

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Online decision aid

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

Group Type ACTIVE_COMPARATOR

Online decision aid

Intervention Type BEHAVIORAL

The Healthwise online shared decision point for Stable Chest Discomfort

Video decision aid

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

Group Type ACTIVE_COMPARATOR

Video decision aid

Intervention Type BEHAVIORAL

The Health Dialog DVD and booklet decision aid for Stable Chest Discomfort

Interventions

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Online decision aid

The Healthwise online shared decision point for Stable Chest Discomfort

Intervention Type BEHAVIORAL

Video decision aid

The Health Dialog DVD and booklet decision aid for Stable Chest Discomfort

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Karen Sepucha

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen R Sepucha, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 17387127 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20820040 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11029677 (View on PubMed)

Other Identifiers

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2014P002292

Identifier Type: -

Identifier Source: org_study_id

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