SurgeryNCT06997328
'5 Rs to Rescue' A Cluster Trial With an Embedded Process Evaluation
An observational study of Surgery and Failure to Rescue, run by University of Cape Town at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Surgery, Failure to Rescue
- What is being tested?
- Implementation of the '5 Rs to Rescue'
- How many people
- 6,000 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Sep 2024to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Surgical wards of participating hospitals in four African countries (Ethiopia, South Africa, Tanzania, Uganda).
Who may be able to join
- Patients aged 18 years and older undergoing any surgery, who receive postoperative care on a participating ward
Who cannot join
- Patients who opt out of trial participation.
- Patients receiving end of life care.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa1 site, 1 recruiting
- Recruiting
Groote Schuur Hospital
Cape Town, Western Cape, 7808
MARGOT FLINT, PhD, +27214045001, margot.flint@uct.ac.za
ROWAN DUYS, MBChB, +27214045002, rowan.duys@uct.ac.za
About this study
'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:
- Risk assessment using the ASOS risk score for all surgical patients,
- 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.
Read the 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
- Being tested
- Implementation of the '5 Rs to Rescue'
- Keywords
- Quality improvement, Postoperative Mortality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of the '5 Rs to Rescue'Other
Quality improvement intervention increases surveillance for patients at risk of 'failure to rescue' after surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Implementation of the '5 Rs to Rescue' |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start1 Sep 2024
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Biccard, University of Cape Town
- Investigators
- Bruce Biccard, MBChB; PhD, Principal investigator, UCT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997328
- Sponsor's protocol ID
- '5 Rs to Rescue'
- Status last verified
- May 2025
- First submitted
- 21 Aug 2024
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29306587ASOS-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.
PubMed 34418380O'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.
PubMed 31420394Johnston 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.
PubMed 24768480Pearse 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.
PubMed 22998715Damschroder 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.
PubMed 36309746Baker 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.
PubMed 26693728
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- '5 Rs to Rescue' A Cluster Trial With an Embedded Process Evaluation
- ClinicalTrials.gov ID
- NCT06997328
- Acronym / sponsor ID
- '5 Rs to Rescue'
- Conditions
- Surgery, Failure to Rescue
- Keywords
- Quality improvement, Postoperative Mortality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
'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:
- Risk assessment using the ASOS risk score for all surgical patients,
- 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-risk surgical patients | – | Other: Implementation of the '5 Rs to Rescue'High-risk patients (ASOS Surgical Risk Calculator Score >10) having surgery, defined as ≥7 high risk patients having surgery per week. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical wards of participating hospitals in four African countries (Ethiopia, South Africa, Tanzania, Uganda).
Key inclusion criteria (1 listed)
- Patients aged 18 years and older undergoing any surgery, who receive postoperative care on a participating ward
Key exclusion criteria (2 listed)
- Patients who opt out of trial participation.
- Patients receiving end of life care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation of the '5 Rs to Rescue'Quality improvement intervention increases surveillance for patients at risk of 'failure to rescue' after surgery | Other | High-risk surgical patients |
Primary outcome
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.
Time frame: 72 hours 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Results publication: PubMed 29306587Biccard 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.
- Results publication: PubMed 34418380ASOS-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.
- Results publication: PubMed 31420394O'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.
- Results publication: PubMed 24768480Johnston 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.
- Results publication: PubMed 22998715Pearse 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.
- Results publication: PubMed 36309746Damschroder 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.
- Results publication: PubMed 26693728Baker 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bruce Biccard, MBChB; PhD principal investigator
UCT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Failure to Rescue, run by University of Cape Town at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Margot Flint, PhD (+27721222111, margot.flint@uct.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06997328, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.