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Use of Visual Decision Aid for Shared Decision Making in Chest Pain

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ClinicalTrials.gov Identifier: NCT03674021
Recruitment Status : Not yet recruiting
First Posted : September 17, 2018
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
National University Hospital, Singapore

Brief Summary:
This study aims to evaluate the use of the chest pain choice (CPC) decision aid as a tool to facilitate discussion between the patient and his/her attending physician with regard to subsequent management plans. Patients aged 21 years and above with low-risk chest pain, as determined by the HEART score (HEART score 0-3), will be included. The investigator's hypothesis is that incorporating the Chest Pain Choice visual aid in shared decision making can help to reduce unnecessary admissions for low risk chest pain to the observation ward, as well as increase patient knowledge with regards to their own condition.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Chest Pain Myocardial Infarction Angina Pectoris Other: Chest Pain Choice visual aid Not Applicable

Detailed Description:

Chest pain is a common presenting complaint in the Emergency Department (ED). Cardiac testing in low-risk patients poses unnecessary costs and resource utilisation, which may in part be due to clinicians adopting a very-low-risk threshold for discharge without testing.

The Chest Pain Choice (CPC) decision aid is a visual aid that was developed to facilitate shared decision-making between physicians and patients who present to the emergency department with chest pain, and has shown to be effective in increasing patient knowledge and decreasing the rate of admission to an observation unit for cardiac testing, among patients with chest pain who are at low risk for acute coronary syndromes. Shared decision making with the use of this visual aid has been shown in other centres to be associated with greater patient knowledge, greater patient involvement in decision making and less frequent admissions, with no increase in major adverse cardiac events (MACE) due to the intervention.

The visual aid includes a brief description of what tests have been done thus far to assess the patient's risk of MACE, a graphic representation of the risk as calculated based on the HEART score, as well as the evaluation options available. The visual aid has been modified from its original form for the local context in terms of viable options for further evaluation.

This study aims to assess if using a visual decision aid for shared decision making between physician and patient can safely help to decrease unnecessary admissions to the ED observation unit, as well as its impact on patient knowledge, satisfaction, as well as 30-day and 60-day Major Adverse Cardiac Events (MACE).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a randomized controlled trial where subjects are stratified by gender and then randomized 1:1 to the intervention (CPC) or control arm (usual care).
Masking: Single (Outcomes Assessor)
Masking Description: The patient, attending physicians, and study team will not be blinded. Outcomes will be assessed through tracing electronic records as well as telephone calls for those whose electronic records are unobtainable. The outcome assessors will be blinded and will follow a telephone script for follow-up.
Primary Purpose: Other
Official Title: The Use of a Visual Decision Aid for Shared Decision Making Among Patients With Chest Pain
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain

Arm Intervention/treatment
Experimental: Intervention Arm
Patients in the intervention arm will receive the Chest Pain Choice visual aid prior to discussion with their primary physician regarding disposition.
Other: Chest Pain Choice visual aid
The Chest Pain Choice (CPC) decision aid is a visual aid that was developed to facilitate shared decision-making between physicians and patients who present to the emergency department with chest pain. The visual aid includes a brief description of what tests have been done thus far to assess the patient's risk of MACE, a graphic representation of the risk as calculated based on the HEART score, as well as the evaluation options available. The visual aid has been modified from its original form for the local context in terms of viable options for further evaluation.

No Intervention: Control Arm
Patients in the control arm will not receive the Chest Pain Choice visual aid and will receive standard care.



Primary Outcome Measures :
  1. Admission to the Emergency Department Observation Unit [ Time Frame: Index visit ]
    Admission to the Emergency Department Observation Unit during index emergency department visit


Secondary Outcome Measures :
  1. Major Adverse Cardiac Events (MACE) at 30 days [ Time Frame: 30 days after index visit ]
    MACE is defined as all-cause mortality, myocardial infarction or coronary revascularisation.

  2. Major Adverse Cardiac Events at 60 days [ Time Frame: 60 days after index visit ]
    MACE is defined as all-cause mortality, myocardial infarction or coronary revascularisation.

  3. Emergency Department Attendance at 30 days [ Time Frame: 30 days after index visit ]
    Repeat attendance to the emergency department

  4. Emergency Department Attendance at 60 days [ Time Frame: 60 days after index visit ]
    Repeat attendance to the emergency department

  5. Stress treadmill electrogram at 30 days [ Time Frame: 30 days after index visit ]
    The presence of stress treadmill electrocardiogram at 30 days post index visit

  6. Stress treadmill electrogram at 60 days [ Time Frame: 60 days after index visit ]
    The presence of stress treadmill electrocardiogram at 60 days post index visit

  7. Stress myocardial perfusion imaging at 30 days [ Time Frame: 30 days after index visit ]
    The presence of stress myocardial perfusion imaging at 30 days post index visit

  8. Stress myocardial perfusion imaging at 60 days [ Time Frame: 60 days after index visit ]
    The presence of stress myocardial perfusion imaging at 60 days post index visit

  9. Stress echocardiogram at 30 days [ Time Frame: 30 days after index visit ]
    The presence of stress echocardiogram at 30 days post index visit

  10. Stress echocardiogram at 60 days [ Time Frame: 60 days after index visit ]
    The presence of stress echocardiogram at 60 days post index visit

  11. Computed tomography of the coronary arteries (CTCA) at 30 days [ Time Frame: 30 days after index visit ]
    The presence of computed tomography of the coronary arteries (CTCA) at 30 days post index visit

  12. Computed tomography of the coronary arteries (CTCA) at 60 days [ Time Frame: 60 days after index visit ]
    The presence of computed tomography of the coronary arteries (CTCA) at 60 days post index visit



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 21 years and above
  • Have low risk chest pain as defined by the HEART score (0-3 points)
  • Be English-literate
  • Have an initial serum troponin that is less than the 99th centile of the normal reference population
  • Have an initial electrocardiogram that is not suggestive of cardiac ischaemia

Exclusion Criteria:

  • Have a HEART score of 4 or more
  • Are not English-literate
  • Have an elevated initial serum troponin
  • Have an initial electrocardiogram that is suggestive of cardiac ischaemia (ST-segment depression or elevation, new onset left bundle brunch block, T-wave inversions, etc.)
  • Have known coronary artery disease
  • Have a prior plan for cardiac intervention or admission
  • Have barriers to outpatient follow-up
  • Are prisoners
  • Are pregnant
  • Are hearing or visually impaired, or are otherwise unable to use the clinical decision aid
  • Do not consent to participation in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674021


Contacts
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Contact: Mui Teng Chua 67795555 mui_teng_chua@nuhs.edu.sg
Contact: Ziwei Lin 67795555 ziwei_lin@nuhs.edu.sg

Sponsors and Collaborators
National University Hospital, Singapore
  Study Documents (Full-Text)

Documents provided by National University Hospital, Singapore:

Publications of Results:
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Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT03674021     History of Changes
Other Study ID Numbers: CPC
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infarction
Myocardial Infarction
Acute Coronary Syndrome
Chest Pain
Angina Pectoris
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pain
Neurologic Manifestations
Signs and Symptoms