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

Acute Coronary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01077037
• Other study ID #: 09-006263
• Status: Completed
• Phase: N/A
• First received: February 24, 2010
• Last updated: May 5, 2015
• Start date: February 2010
• Est. completion date: February 2011

Study information

• Verified date: May 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chest Pain

Intervention

Other:
• Decision Aid
Chest pain choice decision aid

Locations

Country	Name	City	State
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient knowledge	Patient knowledge regarding their short-term risk for an ACS and the risks of radiation exposure.	Immediately after patient visit	No
Secondary	Quality of decision making process	Quality of the decision making process for the patient and clinician	Immediately after patient visit	No
Secondary	Satisfaction with decision aid	Patient and clinician acceptability and satisfaction with the decision aid	Immediately after patient visit	No
Secondary	Proportion of patients who decided to undergo observation unit admission and urgent cardiac stress testing	Proportion of patients who decided to undergo observation unit admission and urgent cardiac stress testing	During the initial ED visit	No
Secondary	Delayed or missed ACS	Rate of delayed or missed ACS	30 days	Yes
Secondary	Economic costs and healthcare utilization	Economic costs and healthcare utilization	30 days	No