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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Acute Coronary Syndrome	Other: Decision Aid	Not Applicable

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	204 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Health Services Research
Official Title:	Impact of a Decision Aid on Patient Participation in Decision Making and Resource Use in Low Risk Chest Pain Patients: A Randomized Trial
Study Start Date :	February 2010
Actual Primary Completion Date :	February 2011
Actual Study Completion Date :	February 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Decision Aid; Receives Decision Aid	Other: Decision Aid; Chest pain choice decision aid
No Intervention: Control; Patient receives usual care.

Outcome Measures

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Primary Outcome Measures :

1. Patient knowledge [ Time Frame: Immediately after patient visit ]
   Patient knowledge regarding their short-term risk for an ACS and the risks of radiation exposure.

Secondary Outcome Measures :

1. Quality of decision making process [ Time Frame: Immediately after patient visit ]
   Quality of the decision making process for the patient and clinician
2. Satisfaction with decision aid [ Time Frame: Immediately after patient visit ]
   Patient and clinician acceptability and satisfaction with the decision aid
3. Proportion of patients who decided to undergo observation unit admission and urgent cardiac stress testing [ Time Frame: During the initial ED visit ]
   Proportion of patients who decided to undergo observation unit admission and urgent cardiac stress testing
4. Delayed or missed ACS [ Time Frame: 30 days ]
   Rate of delayed or missed ACS
5. Economic costs and healthcare utilization [ Time Frame: 30 days ]
   Economic costs and healthcare utilization

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:	Erik P Hess, MD, MSc	Mayo Clinic

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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.

Responsible Party:	Erik P. Hess, MD, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT01077037 History of Changes
Other Study ID Numbers:	09-006263
First Posted:	February 26, 2010
Last Update Posted:	May 6, 2015
Last Verified:	May 2015

Additional relevant MeSH terms:

Acute Coronary Syndrome; Chest Pain; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases	Vascular Diseases; Pain; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms