Impact of a Decision Aid on Patient Decision Making in Emergency Department Chest Pain Patients
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ClinicalTrials.gov Identifier: NCT01077037 |
Recruitment Status :
Completed
First Posted : February 26, 2010
Last Update Posted : May 6, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Coronary Syndrome | Other: Decision Aid | Not Applicable |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: Decision Aid
Receives Decision Aid
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Other: Decision Aid
Chest pain choice decision aid |
No Intervention: Control
Patient receives usual care.
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- Patient knowledge [ Time Frame: Immediately after patient visit ]Patient knowledge regarding their short-term risk for an ACS and the risks of radiation exposure.
- 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

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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)

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 ClinicalTrials.gov identifier (NCT number): NCT01077037
United States, Minnesota | |
Mayo Clinic Rochester | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | Erik P Hess, MD, MSc | Mayo Clinic |
Responsible Party: | Erik P. Hess, MD, Mayo Clinic |
ClinicalTrials.gov 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 |
Acute Coronary Syndrome Chest Pain Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Vascular Diseases Pain Neurologic Manifestations |