Impact of a Decision Aid on Patient Decision Making in Emergency Department Chest Pain Patients

NCT ID: NCT01077037

Last Updated: 2015-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-02-28

Brief Summary

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We are doing a study to assess the impact of including patients in making decision regarding their own medical care in the emergency department. We will randomly assign them to either receive a decision aid or usual care. In doing this, we aim to increase patient satisfaction and safely decrease medical cost.

Detailed Description

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Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Decision Aid

Receives Decision Aid

Group Type EXPERIMENTAL

Decision Aid

Intervention Type OTHER

Chest pain choice decision aid

Control

Patient receives usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Decision Aid

Chest pain choice decision aid

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults with a primary complaint of chest pain.
* Treating clinician's next consideration is observation unit admission for cardiac stress testing.

Exclusion Criteria

* Initial cardiac troponin T value \>99th percentile (\>0.01ng/mL)
* History of coronary artery disease
* coronary revascularization procedure within the previous 30 days
* cocaine use within 72 hours by the clinician's initial history
* pregnancy
* patient cannot read English or have, in their clinician's judgment, major learning barriers, such as visual or hearing impairment or dementia that would compromise their ability to give written informed consent (or use the decision aid)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Erik P. Hess

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erik P Hess, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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Wyatt KD, Branda ME, Inselman JW, Ting HH, Hess EP, Montori VM, LeBlanc A. Genders of patients and clinicians and their effect on shared decision making: a participant-level meta-analysis. BMC Med Inform Decis Mak. 2014 Sep 2;14:81. doi: 10.1186/1472-6947-14-81.

Reference Type DERIVED
PMID: 25179289 (View on PubMed)

Izzo R, de Simone G, Trimarco V, Giudice R, De Marco M, Di Renzo G, De Luca N, Trimarco B. Primary prevention with statins and incident diabetes in hypertensive patients at high cardiovascular risk. Nutr Metab Cardiovasc Dis. 2013 Nov;23(11):1101-6. doi: 10.1016/j.numecd.2012.11.002. Epub 2013 Feb 15.

Reference Type DERIVED
PMID: 23419735 (View on PubMed)

Hess EP, Knoedler MA, Shah ND, Kline JA, Breslin M, Branda ME, Pencille LJ, Asplin BR, Nestler DM, Sadosty AT, Stiell IG, Ting HH, Montori VM. The chest pain choice decision aid: a randomized trial. Circ Cardiovasc Qual Outcomes. 2012 May;5(3):251-9. doi: 10.1161/CIRCOUTCOMES.111.964791. Epub 2012 Apr 10.

Reference Type DERIVED
PMID: 22496116 (View on PubMed)

Pierce MA, Hess EP, Kline JA, Shah ND, Breslin M, Branda ME, Pencille LJ, Asplin BR, Nestler DM, Sadosty AT, Stiell IG, Ting HH, Montori VM. The Chest Pain Choice trial: a pilot randomized trial of a decision aid for patients with chest pain in the emergency department. Trials. 2010 May 17;11:57. doi: 10.1186/1745-6215-11-57.

Reference Type DERIVED
PMID: 20478056 (View on PubMed)

Other Identifiers

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09-006263

Identifier Type: -

Identifier Source: org_study_id

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