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

Tracking Information
First Submitted Date  ICMJE February 24, 2010
First Posted Date  ICMJE February 26, 2010
Last Update Posted Date May 6, 2015
Study Start Date  ICMJE February 2010
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Impact of a Decision Aid on Patient Decision Making in Emergency Department Chest Pain Patients
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Acute Coronary Syndrome
Intervention  ICMJE Other: Decision Aid
Chest pain choice decision aid
Study Arms  ICMJE
  • Experimental: Decision Aid
    Receives Decision Aid
    Intervention: Other: Decision Aid
  • No Intervention: Control
    Patient receives usual care.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2012)
204
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2010)
500
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01077037
Other Study ID Numbers  ICMJE 09-006263
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Erik P. Hess, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Erik P Hess, MD, MSc Mayo Clinic
PRS Account Mayo Clinic
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP