Impact of a Decision Aid on Patient Decision Making in Emergency Department Chest Pain Patients - Full Text View

Purpose

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	Intervention
Acute Coronary Syndrome	Other: Decision Aid


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Chest Pain

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

Patient knowledge [ Time Frame: Immediately after patient visit ] [ Designated as safety issue: No ]
Patient knowledge regarding their short-term risk for an ACS and the risks of radiation exposure.

Secondary Outcome Measures:

Quality of decision making process [ Time Frame: Immediately after patient visit ] [ Designated as safety issue: No ]
Quality of the decision making process for the patient and clinician
Satisfaction with decision aid [ Time Frame: Immediately after patient visit ] [ Designated as safety issue: No ]
Patient and clinician acceptability and satisfaction with the decision aid
Proportion of patients who decided to undergo observation unit admission and urgent cardiac stress testing [ Time Frame: During the initial ED visit ] [ Designated as safety issue: No ]
Proportion of patients who decided to undergo observation unit admission and urgent cardiac stress testing
Delayed or missed ACS [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Rate of delayed or missed ACS
Economic costs and healthcare utilization [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Economic costs and healthcare utilization


Enrollment:	204
Study Start Date:	February 2010
Study Completion Date:	February 2011
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Decision Aid Receives Decision Aid	Other: Decision Aid Chest pain choice decision aid
No Intervention: Control Patient receives usual care.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077037

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

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
Study First Received:	February 24, 2010
Last Updated:	May 5, 2015
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 27, 2016