NCT01077037

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

May 6, 2015

Status Verified

May 1, 2015

Enrollment Period

1 year

First QC Date

February 24, 2010

Last Update Submit

May 5, 2015

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Patient knowledge

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

    Immediately after patient visit

Secondary Outcomes (5)

  • Quality of decision making process

    Immediately after patient visit

  • Satisfaction with decision aid

    Immediately after patient visit

  • Proportion of patients who decided to undergo observation unit admission and urgent cardiac stress testing

    During the initial ED visit

  • Delayed or missed ACS

    30 days

  • Economic costs and healthcare utilization

    30 days

Study Arms (2)

Decision Aid

EXPERIMENTAL

Receives Decision Aid

Other: Decision Aid

Control

NO INTERVENTION

Patient receives usual care.

Interventions

Decision AidOTHER

Chest pain choice decision aid

Decision Aid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with a primary complaint of chest pain.
  • Treating clinician's next consideration is observation unit admission for cardiac stress testing.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (4)

  • 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.

    PMID: 25179289DERIVED

  • 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.

    PMID: 23419735DERIVED

  • 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.

    PMID: 22496116DERIVED

  • 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.

    PMID: 20478056DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Erik P Hess, MD, MSc

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 24, 2010

First Posted

February 26, 2010

Study Start

February 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

May 6, 2015

Record last verified: 2015-05

Locations

US(1)