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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Erik P. Hess, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01077037
First received: February 24, 2010
Last updated: June 22, 2012
Last verified: June 2012
  Purpose

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 Intervention
Acute Coronary Syndrome
Other: Decision Aid
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Patient knowledge [ Time Frame: Immediately after patient visit ] [ Designated as safety issue: No ]
    Patient knowledge regarding their short-term risk for an ACS and the risks of radiation exposure.


Secondary Outcome Measures:
  • Quality of decision making process [ Time Frame: Immediately after patient visit ] [ Designated as safety issue: No ]
    Quality of the decision making process for the patient and clinician

  • Satisfaction with decision aid [ Time Frame: Immediately after patient visit ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Proportion of patients who decided to undergo observation unit admission and urgent cardiac stress testing

  • Delayed or missed ACS [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Rate of delayed or missed ACS

  • Economic costs and healthcare utilization [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Economic costs and healthcare utilization


Enrollment: 204
Study Start Date: February 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Decision Aid
Receives Decision Aid
Other: Decision Aid
Chest pain choice decision aid
No Intervention: Control
Patient receives usual care.
Other: Usual care
We will observe usual care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077037

Locations
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
  More Information

No publications provided by Mayo Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Erik P. Hess, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01077037     History of Changes
Other Study ID Numbers: 09-006263
Study First Received: February 24, 2010
Last Updated: June 22, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chest Pain
Acute Coronary Syndrome
Pain
Signs and Symptoms
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases

ClinicalTrials.gov processed this record on August 18, 2014