Clinical trial NCT01077037: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-02-26
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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)

Primary outcomes:
measure: Patient knowledge
timeFrame: Immediately after patient visit
Secondary outcomes:
measure: Quality of decision making process
timeFrame: Immediately after patient visit
measure: Satisfaction with decision aid
timeFrame: Immediately after patient visit
measure: Proportion of patients who decided to undergo observation unit admission and urgent cardiac stress testing
timeFrame: During the initial ED visit
measure: Delayed or missed ACS
timeFrame: 30 days
measure: Economic costs and healthcare utilization
timeFrame: 30 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Erik P Hess, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.