Shared Decision Making in the Emergency Department: Chest Pain Choice Trial

NCT01969240 | Completed Results DMC

• 1 other identifier: 13-001359
• Study Type: interventional
• Target: 898
• Locations: 1 country
• Sites: 5

Brief Summary

Our long-term goal is to promote evidence-based patient-centered evaluation in the acute setting to more closely tailor testing to disease risk. To compare the use of risk stratification tools with usual clinical approaches to treatment selection or administration, we propose the following:

1. 1.Test if Chest Pain Choice safely improves validated patient-centered outcome measures in a pragmatic parallel patient randomized trial.
2. 2.Test if the decision aid has an effect on healthcare utilization within 30 days after enrollment.

Conditions

Chest Pain; Acute Coronary Syndrome

Keywords

Chest Pain; Decision Aid; Acute Coronary Syndrome; Cardiac; Emergency Department; Cardiac Testing; Healthcare Utilization; Patient Centered Outcomes; Shared Decision Making; Unnecessary hospital admissions

Outcome Measures

Primary Outcomes (1)

• Test if Chest Pain Choice Safely Improves Patient Knowledge.

  Patient knowledge was measured by immediate post-visit survey that included 8 questions about the patient's risk for acute coronary syndrome and the available management options.

  Directly following intervention (on day 1)

Secondary Outcomes (6)

• Test if the Decision Aid Has an Effect on Healthcare Utilization Within 30 Days After Enrollment.

  Within 30 days of study enrollment

• Test if the Decision Aid Safely Improves Patient Engagement.

  Immediately after the intervention (on day 1)

• Major Adverse Cardiac Event (MACE)

  within 30 days of enrollment

• Total Testing Within 45 Days (a Component of Healthcare Utilization)

  45 days

• Decisional Conflict

  Immediately after the visit (day 1)

Study Arms (2)

Chest Pain Choice Decision Aid

ACTIVE COMPARATOR

Patients randomized to the decision aid arm.

Other: Chest Pain Choice Decision Aid

Usual Care

NO INTERVENTION

Patients randomized to the usual care arm (no decision aid used)

Interventions

Chest Pain Choice Decision Aid OTHER

The clinician will review the decision aid with the patient. The decision aid will be used as a tool to facilitate discussion and educate the patient regarding the rationale for their evaluation up to that point in the emergency department visit and their individual risk for a heart attack or pre-heart attack. The clinician will provide the patient with management options consistent with both the patient's values and preferences and the clinician's level of comfort.

Also known as: CPC DA

Chest Pain Choice Decision Aid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + years of age (at least 18).
• Admitted to emergency department for chest pain.
• Being considered by the treating clinician for admission for cardiac testing.

You may not qualify if:

• Ischemic changes on the electrocardiogram not known to be old as determined by the treating clinician in real time.
• Elevated cardiac troponin (cTn) above the 99th percentile reference limit.
• Known coronary artery disease as defined by consensus guidelines on risk stratification studies for emergency department patients with potential acute coronary syndrome (≥ 50% stenosis on cardiac catheterization; prior electrocardiographic changes indicative of ischemia, e.g., ST-segment depression, T-wave inversion, or left bundle branch block; perfusion defects or wall motion abnormalities on previous exercise, pharmacological, or rest imaging studies; previous documentation of acute myocardial infarction; or, if no records are available, patient self-report of coronary artery disease).
• Cocaine use within the previous 72 hours by clinician history.
• Pregnancy.
• Referral to the emergency department by a personal physician for admission.
• Patients who indicate that a hospital different than the site hospital is his or her "hospital of choice" in the event of a return emergency department visit.
• Patients undergoing medical clearance for a detox center or any involuntary court or magistrate order.
• Homelessness, out-of-town residence or other condition known to preclude follow-up.
• Patients in police custody or currently incarcerated individuals.
• Patients who have, in their clinician's best judgment, major communication barriers such as visual or hearing impairment or dementia that would compromise their ability to give written informed consent (or use the decision aid).

Sponsors & Collaborators

• Mayo Clinic: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Indiana University: collaborator
• University of California, Davis: collaborator
• Thomas Jefferson University: collaborator

Study Sites (5)

University of California, Davis

Sacramento, California, 95817, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Indiana University Hospital: IU

Indianapolis, Indiana, 46202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (2)

• Hess EP, Hollander JE, Schaffer JT, Kline JA, Torres CA, Diercks DB, Jones R, Owen KP, Meisel ZF, Demers M, Leblanc A, Shah ND, Inselman J, Herrin J, Castaneda-Guarderas A, Montori VM. Shared decision making in patients with low risk chest pain: prospective randomized pragmatic trial. BMJ. 2016 Dec 5;355:i6165. doi: 10.1136/bmj.i6165.

  PMID: 27919865 DERIVED

• Anderson RT, Montori VM, Shah ND, Ting HH, Pencille LJ, Demers M, Kline JA, Diercks DB, Hollander JE, Torres CA, Schaffer JT, Herrin J, Branda M, Leblanc A, Hess EP. Effectiveness of the Chest Pain Choice decision aid in emergency department patients with low-risk chest pain: study protocol for a multicenter randomized trial. Trials. 2014 May 10;15:166. doi: 10.1186/1745-6215-15-166.

  PMID: 24884807 DERIVED

MeSH Terms

Conditions

Chest Pain; Acute Coronary Syndrome; Emergencies

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Pathologic Processes

Limitations and Caveats

The study had 78% power to detect a 5% difference in major adverse cardiac event (MACE) rate between study arms, using a 1-sided non-inferiority test with an alpha of 0.05.

Results Point of Contact

• Title: Dr. Erik Hess
• Organization: Mayo Clinic

hess.erik@mayo.edu

507-284-7221

Study Officials

• Erik Hess, MD, MSc

  Mayo Clinic, Rochester, MN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, Principal Investigator

Study Record Dates

• First Submitted: October 17, 2013
• First Posted: October 25, 2013
• Study Start: October 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 6, 2018
• Results First Posted: August 6, 2018

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share

Locations

US (5)