Clinical trial NCT06997328: '5 Rs to Rescue' A Cluster Trial With an Embedded Process Evaluation
Official title: '5 Rs to Rescue' A Cluster Trial With an Embedded Process Evaluation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgery
Failure to Rescue
Keywords: Quality improvement
Postoperative Mortality
Lead sponsor: University of Cape Town
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgical wards of participating hospitals in four African countries (Ethiopia, South Africa, Tanzania, Uganda).

Brief summary: '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.

Detailed description: INTRODUCTION 'Failure to rescue' describes the preventable death of a patient following a complication after surgery. Patients who develop complications after surgery, such as haemorrhage or infection, begin to deteriorate physiologically and become acutely unwell. This is usually identified by careful monitoring of the patient's basic 'vital signs' which include pulse rate, respiratory rate, oxygen saturation, blood pressure and consciousness level. However, if physiological deterioration is not identified and treated in a timely manner, it will progress and lead to organ dysfunction and then organ failure. This will ultimately lead to cardio-respiratory arrest and the death of the patient. 'Failure to rescue' can be used as a key concept in delivering safe and effective perioperative care as well as a healthcare quality metric in general. The first African Surgical Outcomes Study (ASOS-1) showed that 'failure to rescue' is the mode of death in 19 out of 20 deaths following surgery across Africa. Hospitals in high-income countries use early warning systems to monitor patients after surgery and trigger the escalation of care for patients who are critically ill to ensure prompt treatment. However, these systems do not exist in many resource-poor African hospitals where nurse: patient ratios can be as high as 1:35 and limit capacity-to-rescue within the system. Furthermore, in many African hospitals early warning systems are not used to monitor patients following surgery. These factors contribute to the higher mortality post-surgery in Africa compared to high-income countries. As patient outcomes tend to improve when enhanced monitoring increases the identification and treatment of critically ill patients, the study has co-produced a complex intervention with healthcare staff, community engagement and involvement (CEI) partners, and the Institute for Health Improvement (IHI) across four African countries (Ethiopia, South Africa, Tanzania and Uganda) to improve the capacity-to-rescue. This is a multi-centre, cluster trial with a baseline assessment to evaluate the efficacy of the '5 Rs to Rescue' quality improvement intervention using a mixed-methods process evaluation of the trial intervention. The intervention focuses on improving five main areas of patient management following surgery: 1) Risk assessment, 2) Recognition of patient deterioration, 3) Response to patient deterioration, 4) Reassessment following intervention to manage deterioration, and 5) Reflection on care provided following a patient's death. The complex quality improvement (QI) intervention is known as '5 Rs to Rescue'. Ultimately, the researchers intend 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 hopes to demonstrate that the intervention can decrease 'failure to rescue' in Africa, and improve postoperative survival.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patients who opt out of trial participation.
* Patients receiving end of life care.

Primary outcomes:
measure: 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.
timeFrame: 72 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
state: Western CAPE
Study officials:
affiliation: UCT
name: Bruce Biccard, MBChB; PhD
role: PRINCIPAL_INVESTIGATOR
References:
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