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

Impact of a Decision Aid on Patient Participation in Decision Making and Resource Use in Low Risk Chest Pain Patients: A Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Other: Decision Aid

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient knowledge	Patient knowledge regarding their short-term risk for an ACS and the risks of radiation exposure.	Immediately after patient visit

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Erik P Hess, MD, MSc, Mayo Clinic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: February 24, 2010
• First Submitted That Met QC Criteria: February 25, 2010
• First Posted (Estimate): February 26, 2010

Study Record Updates

• Last Update Posted (Estimate): May 6, 2015
• Last Update Submitted That Met QC Criteria: May 5, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Acute Coronary Syndrome
• Other Study ID Numbers: 09-006263