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

NCT03674021 | Terminated

• 1 other identifier: CPC
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome; Chest Pain; Myocardial Infarction; Angina Pectoris

Outcome Measures

Primary Outcomes (1)

• Admission to the Emergency Department Observation Unit

  Admission to the Emergency Department Observation Unit during index emergency department visit

  Index visit

Secondary Outcomes (12)

• Major Adverse Cardiac Events (MACE) at 30 days

  30 days after index visit

• Major Adverse Cardiac Events at 60 days

  60 days after index visit

• Emergency Department Attendance at 30 days

  30 days after index visit

• Emergency Department Attendance at 60 days

  60 days after index visit

• Stress treadmill electrogram at 30 days

  30 days after index visit

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

Patients in the control arm will not receive the Chest Pain Choice visual aid and will receive standard care.

Interventions

Chest Pain Choice visual aid OTHER

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.

Intervention Arm

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

Mui Teng Chua

Singapore, Central, 119074, Singapore

Location

Related Publications (2)

• 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: 22496116 RESULT

• Anderson RT, Montori VM, Shah ND, Ting HH, Pencille LJ, Demers M, Kline JA, Diercks DB, Hollander JE, Torres CA, Schaffer JT, Herrin J, Branda M, Leblanc A, Hess EP. Effectiveness of the Chest Pain Choice decision aid in emergency department patients with low-risk chest pain: study protocol for a multicenter randomized trial. Trials. 2014 May 10;15:166. doi: 10.1186/1745-6215-15-166.

  PMID: 24884807 RESULT

MeSH Terms

Conditions

Acute Coronary Syndrome; Chest Pain; Myocardial Infarction; Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 26, 2018
• First Posted: September 17, 2018
• Study Start: March 1, 2019
• Primary Completion: September 3, 2021
• Study Completion: September 3, 2021
• Last Updated: April 20, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)