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

• ClinicalTrials.gov Identifier: NCT01077037
• Recruitment Status: Completed
• First Posted: February 26, 2010
• Last Update Posted: May 6, 2015
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Erik P. Hess, Mayo Clinic

Tracking Information

• First Submitted Date: February 24, 2010
• First Posted Date: February 26, 2010
• Last Update Posted Date: May 6, 2015
• Study Start Date: February 2010
• Actual Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 25, 2010)

Patient knowledge [ Time Frame: Immediately after patient visit ]

Patient knowledge regarding their short-term risk for an ACS and the risks of radiation exposure.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 25, 2010)

• Quality of decision making process [ Time Frame: Immediately after patient visit ]
  Quality of the decision making process for the patient and clinician
• Satisfaction with decision aid [ Time Frame: Immediately after patient visit ]
  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 ]
  Proportion of patients who decided to undergo observation unit admission and urgent cardiac stress testing
• Delayed or missed ACS [ Time Frame: 30 days ]
  Rate of delayed or missed ACS
• Economic costs and healthcare utilization [ Time Frame: 30 days ]
  Economic costs and healthcare utilization

Original Secondary Outcome Measures (submitted: February 25, 2010)

• Quality of decision making process [ Time Frame: Immediately after patient visit ]
  Quality of the decision making process for the patient and clinician
• Satisfaction with decision aid [ Time Frame: Immediately after patient visit ]
  Patient and clinician acceptability and satisfaction with the decision aid.
• Rate of urgent cardiac stress testing [ Time Frame: During the initial ED visit ]
  Rate of urgent cardiac stress testing
• Delayed or missed ACS [ Time Frame: 30 days ]
  Rate of delayed or missed ACS

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Impact of a Decision Aid on Patient Decision Making in Emergency Department Chest Pain Patients
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Health Services Research
• Condition: Acute Coronary Syndrome

Intervention

Other: Decision Aid

Chest pain choice decision aid

Study Arms

• Experimental: Decision Aid
  Receives Decision Aid
  Intervention: Other: Decision Aid
• No Intervention: Control
  Patient receives usual care.

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 4, 2012): 204
• Original Estimated Enrollment (submitted: February 25, 2010): 500
• Actual Study Completion Date: February 2011
• Actual Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01077037
• Other Study ID Numbers: 09-006263
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Erik P. Hess, Mayo Clinic
• Study Sponsor: Mayo Clinic
• Collaborators: Not Provided

Investigators

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

• PRS Account: Mayo Clinic
• Verification Date: May 2015