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Completed

NCT Number: NCT01969240

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

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. Test if Chest Pain Choice safely improves validated patient-centered outcome measures in a pragmatic parallel patient randomized trial.

Hypothesis: The intervention will significantly increase patient knowledge, engagement, and satisfaction with no increase in adverse events. 2. Test if the decision aid has an effect on healthcare utilization within 30 days after enrollment.

Hypothesis: The intervention will significantly reduce the rate of hospital admission, rate of cardiac testing, and total healthcare utilization.

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Key information

Conditions

Chest Pain Acute Coronary Syndrome Cardiovascular Diseases Disease Attributes Emergencies Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis, Sacramento, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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).

Treatment and study plan

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.

Other names: CPC DA

Primary outcomes

  1. Test if Chest Pain Choice Safely Improves Patient Knowledge.

    Time frame: Directly following intervention (on day 1)

    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.

Secondary outcomes

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

    Time frame: Within 30 days of study enrollment

    We will measure the effect of the decision aid on the frequency of hospital admission and cardiac testing within 30 days of enrollment.

  2. Test if the Decision Aid Safely Improves Patient Engagement.

    Time frame: Immediately after the intervention (on day 1)

    • Patient engagement in the decision-making process as measured by the OPTION scale. The OPTION scale is composed of 12 items with a value of 0-4; they are summed, divided by 48, and then multiplied by 100. Scores range from 0-100, where higher scores are reflective of higher levels of patient engagement.

  3. Major Adverse Cardiac Event (MACE)

    Time frame: within 30 days of enrollment

    A MACE was defined as acute myocardial infarction, death due to a cardiac or unknown cause, emergency revascularization, ventricular arrhythmia, or cardiogenic shock.

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

    Time frame: 45 days

    In addition to measuring the effect of the decision aid on the frequency of hospital admission and cardiac testing within 30 days, we measured the total number of tests of any type within 45 days. Although we pre-specified 30-day healthcare utilization, on further discussion among the investigative team the consensus was that we collected utilization data out to 45 days and reporting testing utilization at 45 days will provide more robust results.

  5. Decisional Conflict

    Time frame: Immediately after the visit (day 1)

    Decisional conflict, which represents the degree of uncertainty patients experience related to feeling uninformed about the management options, is measured by the decisional conflict scale. The decisional conflict scale includes 16 items that are scored from 0-4; the items are summed, divided by 16, and then multiplied by 25. The scale is from 0-100, where higher scores are reflective of increased patient uncertainty about the choice.

  6. Physician Trust

    Time frame: Immediately after the visit (day 1)

    The trust in physician scale consists of 9 items scored from 1-5; the items are subtracted by 1, summed, divided by 9, and then multiplied by 25. The scale ranges from 0-100, where higher values are reflective of higher levels of patient trust in their physician.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Indiana University
  • Patient-Centered Outcomes Research Institute
  • Thomas Jefferson University
  • University of California, Davis

Registry information

Official study title

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

Acronym: CPC

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 25, 2013
Registry last updated
Aug 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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