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

NCT06997328 | Recruiting

• 1 other identifier: '5 Rs to Rescue'
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

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. 1.Risk assessment using the ASOS risk score for all surgical patients,
2. 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.

Conditions

Surgery; Failure to Rescue

Keywords

Quality improvement; Postoperative Mortality

Outcome Measures

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.

  72 hours after surgery

Study Arms (1)

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.

Other: Implementation of the '5 Rs to Rescue'

Interventions

Implementation of the '5 Rs to Rescue' OTHER

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

High-risk surgical patients

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Cape Town: lead

Study Sites (1)

Groote Schuur Hospital

Cape Town, Western Cape, 7808, South Africa

RECRUITING

Related Publications (7)

• 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.

  PMID: 29306587 RESULT

• 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.

  PMID: 34418380 RESULT

• 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.

  PMID: 31420394 RESULT

• 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.

  PMID: 24768480 RESULT

• 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.

  PMID: 22998715 RESULT

• 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.

  PMID: 36309746 RESULT

• 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.

  PMID: 26693728 RESULT

Study Officials

• Bruce Biccard, MBChB; PhD

  UCT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margot Flint, PhD

CONTACT

+27721222111; margot.flint@uct.ac.za

Bruce Biccard, MBChB; PhD

CONTACT

+27761606387; bruce.biccard@uct.ac.za

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: May 30, 2025
• Study Start: September 1, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2025-05

Locations

ZA (1)