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OpenTrials
Completed

NCT Number: NCT01077037

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

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Decision Aid

Other

Chest pain choice decision aid

Primary outcomes

  1. Patient knowledge

    Time frame: Immediately after patient visit

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

Secondary outcomes

  1. Quality of decision making process

    Time frame: Immediately after patient visit

    Quality of the decision making process for the patient and clinician

  2. Satisfaction with decision aid

    Time frame: Immediately after patient visit

    Patient and clinician acceptability and satisfaction with the decision aid

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

    Time frame: During the initial ED visit

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

  4. Delayed or missed ACS

    Time frame: 30 days

    Rate of delayed or missed ACS

  5. Economic costs and healthcare utilization

    Time frame: 30 days

    Economic costs and healthcare utilization

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Impact of a Decision Aid on Patient Participation in Decision Making and Resource Use in Low Risk Chest Pain Patients: A Randomized Trial

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 26, 2010
Registry last updated
May 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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