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

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision Aid
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Coronary Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Mayo Clinic Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Decision Aid

Control

Arm Description

Receives Decision Aid

Patient receives usual care.

Outcomes

Primary Outcome Measures

Patient knowledge
Patient knowledge regarding their short-term risk for an ACS and the risks of radiation exposure.

Secondary Outcome Measures

Quality of decision making process
Quality of the decision making process for the patient and clinician
Satisfaction with decision aid
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
Proportion of patients who decided to undergo observation unit admission and urgent cardiac stress testing
Delayed or missed ACS
Rate of delayed or missed ACS
Economic costs and healthcare utilization
Economic costs and healthcare utilization

Full Information

First Posted
February 24, 2010
Last Updated
May 5, 2015
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01077037
Brief Title
Impact of a Decision Aid on Patient Decision Making in Emergency Department Chest Pain Patients
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 Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Decision Aid
Arm Type
Experimental
Arm Description
Receives Decision Aid
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patient receives usual care.
Intervention Type
Other
Intervention Name(s)
Decision Aid
Intervention Description
Chest pain choice decision aid
Primary Outcome Measure Information:
Title
Patient knowledge
Description
Patient knowledge regarding their short-term risk for an ACS and the risks of radiation exposure.
Time Frame
Immediately after patient visit
Secondary Outcome Measure Information:
Title
Quality of decision making process
Description
Quality of the decision making process for the patient and clinician
Time Frame
Immediately after patient visit
Title
Satisfaction with decision aid
Description
Patient and clinician acceptability and satisfaction with the decision aid
Time Frame
Immediately after patient visit
Title
Proportion of patients who decided to undergo observation unit admission and urgent cardiac stress testing
Description
Proportion of patients who decided to undergo observation unit admission and urgent cardiac stress testing
Time Frame
During the initial ED visit
Title
Delayed or missed ACS
Description
Rate of delayed or missed ACS
Time Frame
30 days
Title
Economic costs and healthcare utilization
Description
Economic costs and healthcare utilization
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik P Hess, MD, MSc
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25179289
Citation
Wyatt KD, Branda ME, Inselman JW, Ting HH, Hess EP, Montori VM, LeBlanc A. Genders of patients and clinicians and their effect on shared decision making: a participant-level meta-analysis. BMC Med Inform Decis Mak. 2014 Sep 2;14:81. doi: 10.1186/1472-6947-14-81.
Results Reference
derived
PubMed Identifier
23419735
Citation
Izzo R, de Simone G, Trimarco V, Giudice R, De Marco M, Di Renzo G, De Luca N, Trimarco B. Primary prevention with statins and incident diabetes in hypertensive patients at high cardiovascular risk. Nutr Metab Cardiovasc Dis. 2013 Nov;23(11):1101-6. doi: 10.1016/j.numecd.2012.11.002. Epub 2013 Feb 15.
Results Reference
derived
PubMed Identifier
22496116
Citation
Hess EP, Knoedler MA, Shah ND, Kline JA, Breslin M, Branda ME, Pencille LJ, Asplin BR, Nestler DM, Sadosty AT, Stiell IG, Ting HH, Montori VM. The chest pain choice decision aid: a randomized trial. Circ Cardiovasc Qual Outcomes. 2012 May;5(3):251-9. doi: 10.1161/CIRCOUTCOMES.111.964791. Epub 2012 Apr 10.
Results Reference
derived
PubMed Identifier
20478056
Citation
Pierce MA, Hess EP, Kline JA, Shah ND, Breslin M, Branda ME, Pencille LJ, Asplin BR, Nestler DM, Sadosty AT, Stiell IG, Ting HH, Montori VM. The Chest Pain Choice trial: a pilot randomized trial of a decision aid for patients with chest pain in the emergency department. Trials. 2010 May 17;11:57. doi: 10.1186/1745-6215-11-57.
Results Reference
derived

Learn more about this trial

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

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