'5 Rs to Rescue' A Cluster Trial With an Embedded Process Evaluation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorUniversity of Cape Town

About this trial

'Failure to rescue' describes the preventable death of a patient following the absence of timely identification and treatment of a complication after surgery. The absence of systems contributes to the higher mortality post-surgery in Africa compared to high-income countries. To mitigate this, a complex quality improvement (QI) intervention has been designed focusing on improving five main areas of patient management following surgery termed as '5 Rs to Rescue'. The study will take place in 20 centers in 4 countries - Ethiopia, South Africa, Tanzania, and Uganda. This a multi-center, mixed methods, cluster trial with a baseline assessment to evaluate the efficacy of the QI intervention. To study is aimed to evaluate whether implementation of the '5 Rs to Rescue' quality improvement intervention increases surveillance for patients at risk of 'failure to rescue' after surgery in hospitals in Africa.

The '5 Rs to Rescue' includes:

1. Risk assessment using the ASOS risk score for all surgical patients, 2. Recognition of patient deterioration by regular, protocolized vital signs monitoring plus use of an Early Warning Score (EWS) system. 3. Response to deterioration by protocolized escalation based upon EWS plus protocolized care pathways for common complications (hypoxia, hypovolemia, sepsis). 4. Reassessment following deterioration by protocolized re-assessment based upon EWS, and 5. Reflection on care provided following a patient's deterioration or death using a structured review tool at regular reflection meetings.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 years and older undergoing any surgery, who receive postoperative care on a participating ward

Disqualifiers

Patients who opt out of trial participation.

Patients receiving end of life care.

Trial population

Surgical wards of participating hospitals in four African countries (Ethiopia, South Africa, Tanzania, Uganda).

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Implementation of the '5 Rs to Rescue'

    Other intervention

    Quality improvement intervention increases surveillance for patients at risk of 'failure to rescue' after surgery

Treatment groups

6,000 Participants
are divided into 1 treatment group
Group A: High-risk surgical patients1 intervention

Trial outcomes

Primary outcomes

1

Report site specific interventions and findings that explain how and why the 5R's to Rescue Quality Improvement Programme was effective or not in reducing in-hospital death after surgery.

The complex QI intervention is known as '5 Rs to Rescue'. Ultimately, the study intends to conduct a large international cluster randomised trial of the '5 Rs to Rescue' intervention comparing patient important outcomes for patients undergoing major surgery between intervention and usual care hospitals. The study is aiming to demonstrate that the '5 Rs to Rescue' intervention can decrease 'failure to rescue' in Africa, and improve postoperative survival.

Time frame
72 hours after surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.