Shared decision-making in the emergency department using T-MACS Choice for patients experiencing chest pain

The Troponin-only Manchester Acute Coronary Syndromes (T-MACS) Choice feasibility study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13242733

Enrollment

800

Registered

2021-10-19

Start date

2022-01-03

Completion date

Unknown

Last updated

2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute coronary syndromes Circulatory System

Interventions

We will use a cluster stepped-wedge randomised controlled trial design to investigate the impact of shared decision-making in the envisaged full scale study. In this feasibility study we will run a mu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult patients aged 18 years or above 2. Presenting to the ED with: 2.1. Pain, discomfort, or pressure in the chest, epigastrium, neck, jaw, or upper limbs 2.2. No obvious non-cardiac source 2.3. Symptoms the treating emergency physicians feel warrant investigation for suspected ACS

Exclusion criteria

Exclusion criteria: 1. Patients with peak symptoms >12 hours before presenting to the ED 2. Patients requiring referral for immediate primary percutaneous coronary intervention due to unequivocal evidence of ST elevation myocardial infarction 3. Patients requiring hospital admissions for another medical condition 4. Patients that lack mental capacity to provide written informed consent 5. Patients whose level of English does not allow them to participate in the SDM conversation in a meaningful way.

Design outcomes

Primary

Measure	Time frame
Measured at the end of the study (feasibility outcomes): 1. Number of eligible participants per months recruitment period measured as natural frequency in the eligibility log (T-MACS database) 2. Recruitment rate measured as percentage of eligible patients that did not opt-out by referencing the opt-out log against the eligibility log 3. Retention measured as percentage of those eligible who complete follow up and potential subsequent questionnaires without opt-out at a later stage (referencing opt-out log) 4. Percentage of missing data in secondary outcomes measured recorded in questionnaires and 30 days follow up case report forms data entered onto REDCap database 5. Ability to deliver physician training in shared decision making measured with qualitative notes from trainers to record potential problems of delivering physician training sessions as well as free text feedback on the session from physician training questionnaire 6. Ability to transition between control and intervention in transition time of 1 month measured with qualitative notes recording any problems in the process causing potential transition delays	—

Measure

Time frame

Measured at the end of the study (feasibility outcomes): 1. Number of eligible participants per months recruitment period measured as natural frequency in the eligibility log (T-MACS database) 2. Recruitment rate measured as percentage of eligible patients that did not opt-out by referencing the opt-out log against the eligibility log 3. Retention measured as percentage of those eligible who complete follow up and potential subsequent questionnaires without opt-out at a later stage (referencing opt-out log) 4. Percentage of missing data in secondary outcomes measured recorded in questionnaires and 30 days follow up case report forms data entered onto REDCap database 5. Ability to deliver physician training in shared decision making measured with qualitative notes from trainers to record potential problems of delivering physician training sessions as well as free text feedback on the session from physician training questionnaire 6. Ability to transition between control and intervention in transition time of 1 month measured with qualitative notes recording any problems in the process causing potential transition delays

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Secondary

Measure	Time frame
1. Decisional conflict measured with the low literacy decisional conflict scale questionnaire as part of the patient post-encounter questionnaire on initial ED attendance 2. Control Preferences Scale instrument completed as part of the patient post-encounter questionnaire on initial ED attendance 3. Patient disposition recorded at 30 days follow up from medical records review distinguishing four categories (discharge home from ED without serial troponin sampling, discharge home from ED with patient returning a later time for serial troponin sampling, admission under ED for serial troponin sampling, admission under medical team for serial troponin sampling). Choice rates will be recorded in the shared decision making group will be extracted from decision aid copies on the medical record at 30 days follow up 4. Cardiac events at 30 days follow up including index visit AMI as well as a composite of MACE consisting of incident AMI, cardiac death and urgent coronary revascularisation including percutaneous coronary intervention and coronary artery bypass graft will be measured by review of the participants medical record. Cardiac outcomes will be adjudicated by two independent investigators with access to relevant clinical information but blinded for research results. 5. Patient decision regret measured by validated 5-item decision regret scale questionnaire in participants in the shared decision making intervention group at 30 days following their initial ED attendance 6. Physician experience with 6.1. Delivering SDM intervention by a physician post encounter questionnaire that is completed after the initial patient encounter in the ED 6.2. Training received on SDM measured by a clinician training questionnaire provided to them at the end of the training session physicians receive in the transition period between and control and intervention period	—

Measure

Time frame

1. Decisional conflict measured with the low literacy decisional conflict scale questionnaire as part of the patient post-encounter questionnaire on initial ED attendance 2. Control Preferences Scale instrument completed as part of the patient post-encounter questionnaire on initial ED attendance 3. Patient disposition recorded at 30 days follow up from medical records review distinguishing four categories (discharge home from ED without serial troponin sampling, discharge home from ED with patient returning a later time for serial troponin sampling, admission under ED for serial troponin sampling, admission under medical team for serial troponin sampling). Choice rates will be recorded in the shared decision making group will be extracted from decision aid copies on the medical record at 30 days follow up 4. Cardiac events at 30 days follow up including index visit AMI as well as a composite of MACE consisting of incident AMI, cardiac death and urgent coronary revascularisation including percutaneous coronary intervention and coronary artery bypass graft will be measured by review of the participants medical record. Cardiac outcomes will be adjudicated by two independent investigators with access to relevant clinical information but blinded for research results. 5. Patient decision regret measured by validated 5-item decision regret scale questionnaire in participants in the shared decision making intervention group at 30 days following their initial ED attendance 6. Physician experience with 6.1. Delivering SDM intervention by a physician post encounter questionnaire that is completed after the initial patient encounter in the ED 6.2. Training received on SDM measured by a clinician training questionnaire provided to them at the end of the training session physicians receive in the transition period between and control and intervention period

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026