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

NCT ID: NCT06997328

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 6000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2026-09-01

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.

Conditions

Surgery; Failure to Rescue

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

High-risk surgical patients

High-risk patients (ASOS Surgical Risk Calculator Score \>10) having surgery, defined as ≥7 high risk patients having surgery per week.

Implementation of the '5 Rs to Rescue'

Intervention Type: OTHER

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

Interventions

Implementation of the '5 Rs to Rescue'

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cape Town

OTHER

Sponsor Role: lead

Responsible Party

Bruce Biccard

Co-Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bruce Biccard, MBChB; PhD

Role: PRINCIPAL_INVESTIGATOR

UCT

Locations

Groote Schuur Hospital

Cape Town, Western Cape, South Africa

Site Status: RECRUITING

Countries

South Africa

Central Contacts

Margot Flint, PhD

Role: CONTACT

margot.flint@uct.ac.za

+27721222111

Bruce Biccard, MBChB; PhD

Role: CONTACT

bruce.biccard@uct.ac.za

+27761606387

Facility Contacts

MARGOT FLINT, PhD

Role: primary

margot.flint@uct.ac.za

+27214045001

ROWAN DUYS, MBChB

Role: backup

rowan.duys@uct.ac.za

+27214045002

References

ASOS-2 Investigators. Enhanced postoperative surveillance versus standard of care to reduce mortality among adult surgical patients in Africa (ASOS-2): a cluster-randomised controlled trial. Lancet Glob Health. 2021 Oct;9(10):e1391-e1401. doi: 10.1016/S2214-109X(21)00291-6. Epub 2021 Aug 19.

Reference Type: RESULT

PMID: 34418380 (View on PubMed)

Biccard BM, Madiba TE, Kluyts HL, Munlemvo DM, Madzimbamuto FD, Basenero A, Gordon CS, Youssouf C, Rakotoarison SR, Gobin V, Samateh AL, Sani CM, Omigbodun AO, Amanor-Boadu SD, Tumukunde JT, Esterhuizen TM, Manach YL, Forget P, Elkhogia AM, Mehyaoui RM, Zoumeno E, Ndayisaba G, Ndasi H, Ndonga AKN, Ngumi ZWW, Patel UP, Ashebir DZ, Antwi-Kusi AAK, Mbwele B, Sama HD, Elfiky M, Fawzy MA, Pearse RM; African Surgical Outcomes Study (ASOS) investigators. Perioperative patient outcomes in the African Surgical Outcomes Study: a 7-day prospective observational cohort study. Lancet. 2018 Apr 21;391(10130):1589-1598. doi: 10.1016/S0140-6736(18)30001-1. Epub 2018 Jan 3.

Reference Type: RESULT

PMID: 29306587 (View on PubMed)

O'Cathain A, Croot L, Duncan E, Rousseau N, Sworn K, Turner KM, Yardley L, Hoddinott P. Guidance on how to develop complex interventions to improve health and healthcare. BMJ Open. 2019 Aug 15;9(8):e029954. doi: 10.1136/bmjopen-2019-029954.

Reference Type: RESULT

PMID: 31420394 (View on PubMed)

Johnston M, Arora S, King D, Stroman L, Darzi A. Escalation of care and failure to rescue: a multicenter, multiprofessional qualitative study. Surgery. 2014 Jun;155(6):989-94. doi: 10.1016/j.surg.2014.01.016. Epub 2014 Feb 7.

Reference Type: RESULT

PMID: 24768480 (View on PubMed)

Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012 Sep 22;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9.

Reference Type: RESULT

PMID: 22998715 (View on PubMed)

Damschroder LJ, Reardon CM, Widerquist MAO, Lowery J. The updated Consolidated Framework for Implementation Research based on user feedback. Implement Sci. 2022 Oct 29;17(1):75. doi: 10.1186/s13012-022-01245-0.

Reference Type: RESULT

PMID: 36309746 (View on PubMed)

Baker T, Schell CO, Lugazia E, Blixt J, Mulungu M, Castegren M, Eriksen J, Konrad D. Vital Signs Directed Therapy: Improving Care in an Intensive Care Unit in a Low-Income Country. PLoS One. 2015 Dec 22;10(12):e0144801. doi: 10.1371/journal.pone.0144801. eCollection 2015.

Reference Type: RESULT

PMID: 26693728 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

'5 Rs to Rescue'

Identifier Type: -

Identifier Source: org_study_id