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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01077037
Recruitment Status : Completed
First Posted : February 26, 2010
Last Update Posted : May 6, 2015
Information provided by (Responsible Party):
Erik P. Hess, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Other: Decision Aid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : February 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain

Arm Intervention/treatment
Experimental: Decision Aid
Receives Decision Aid
Other: Decision Aid
Chest pain choice decision aid

No Intervention: Control
Patient receives usual care.

Primary Outcome Measures :
  1. Patient knowledge [ Time Frame: Immediately after patient visit ]
    Patient knowledge regarding their short-term risk for an ACS and the risks of radiation exposure.

Secondary Outcome Measures :
  1. Quality of decision making process [ Time Frame: Immediately after patient visit ]
    Quality of the decision making process for the patient and clinician

  2. Satisfaction with decision aid [ Time Frame: Immediately after patient visit ]
    Patient and clinician acceptability and satisfaction with the decision aid

  3. 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

  4. Delayed or missed ACS [ Time Frame: 30 days ]
    Rate of delayed or missed ACS

  5. Economic costs and healthcare utilization [ Time Frame: 30 days ]
    Economic costs and healthcare utilization

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01077037

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United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Erik P Hess, MD, MSc Mayo Clinic
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Erik P. Hess, MD, Mayo Clinic Identifier: NCT01077037    
Other Study ID Numbers: 09-006263
First Posted: February 26, 2010    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Chest Pain
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Neurologic Manifestations