SNAP 3: An observational study to understand frailty and delirium in older surgical patients
| ISRCTN | ISRCTN67043129 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67043129 |
| IRAS number | 294618, 302033 |
| Secondary identifying numbers | IRAS 294618 (England, Wales, Northern Ireland), IRAS 302033 (Scotland), CPMS 49713 |
- Submission date
- 05/11/2021
- Registration date
- 08/12/2021
- Last edited
- 08/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Background and study aims
More older people are undergoing surgery as the population ages and surgical care improves. Frailty is an age-related syndrome that increases an individuals' vulnerability to adverse outcomes in response to illness, injury and surgery. Delirium is a period of temporarily altered, fluctuating consciousness, triggered by illness, surgery or environment. There is evidence that surgical outcomes are worse in patients with these conditions.
The aim of SNAP3 is to investigate which patients are frail and which are at risk of delirium. It will investigate current perioperative care and its outcomes.
Who can participate?
Surgical patients who are 60 years and over undergoing surgery from 21st-25th March 2022
What does the study involve?
Participants recruited will have the following information collected:
1. Notes review and data linkage with government agencies, for demographic, medical and socioeconomic details
2. Frailty assessments: 2 requiring active participant involvement, 2 using electronic medical records
3. Assessments for delirium and medical complications from a survey
4. Quality of life email/telephone survey 4 months postoperatively
What are the possible benefits and risks of participating?
The benefit to participants is the knowledge that they have contributed to the care of older surgical patients, there is no direct clinical benefit. The interventions are survey based only, the only risk is that participants could potentially be upset by survey content, however, this is unlikely.
Where is the study run from?
University of Nottingham (UK)
When is the study starting and how long is it expected to run for?
June 2021 to May 2022
Who is funding the study?
Royal College of Anaesthetists (UK)
Frances and Augustus Newman Foundation (UK)
Who is the main contact?
Dr Samuel Nava, Samuel.Nava@nottingham.ac.uk
Contact information
Dr Claire Swarbrick
Scientific
Scientific
Anaesthetics Department
Royal Devon and Exeter Hospital
Exeter
EX2 4EQ
United Kingdom
 ORCID ID |
0000-0002-9448-2316 |
|---|---|
| Phone | +44 (0)7502225186 |
| claire.swarbrick@nottingham.ac.uk |
Miss Karen Williams
Public
Public
Royal College of Anaesthetists
Churchill House
35 Red Lion Square
London
WC1R 4SG
United Kingdom
| Phone | +44(0)2070921500 |
|---|---|
| kwilliams@rcoa.ac.uk |
Dr Samuel Nava
Scientific
Scientific
-
Bath
-
United Kingdom
| ORCID ID |
0000-0002-5318-9877 |
|---|---|
| Phone | +44 (0)7823777624 |
| Samuel.Nava@nottingham.ac.uk |
Study information
| Study design | Multi-centre prospective observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | https://www.niaa-hsrc.org.uk/SNAP-3-Frailty-and-Delirium-Hospital-List |
| Scientific title | The 3rd Sprint National Anaesthesia Project (SNAP): An observational study of frailty, multimorbidity and delirium in older people in the perioperative period |
| Study acronym | SNAP 3 |
| Study hypothesis | Current study hypothesis as of 09/08/2022: To characterise the epidemiology of frailty, multi-morbidity and postoperative delirium in approximately 8,000 older people undergoing surgery in the UK 1. Examine the relationship between frailty, multimorbidity and perioperative outcomes across all surgery types 2. Describe the variation in hospital-level and patient-level frailty-related interventions 3. Identify associations between hospital-level and patient-level frailty-related interventions and outcome 4. Develop and internally validate a risk-prediction tool for postoperative delirium _____ Previous study hypothesis: To characterise the epidemiology of frailty, multi-morbidity and postoperative delirium in approximately 12,000 older people undergoing surgery in the UK 1. Examine the relationship between frailty, multimorbidity and perioperative outcomes across all surgery types 2. Describe the variation in hospital-level and patient-level frailty-related interventions 3. Identify associations between hospital-level and patient-level frailty-related interventions and outcome 4. Develop and internally validate a risk-prediction tool for postoperative delirium |
| Ethics approval(s) | 1. Approved 28/06/2021, Wales Research Ethics Committee 7 (Health and Care Research Wales Support and Delivery Centre, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, UK; +44(0)2920 230457; Wales.REC7@wales.nhs.uk), ref 21/WA/0203 2. Approved 05/08/2021, Scotland A REC (2nd Floor, Waverley Gate, 2-4 Waterloo Place, Edinburgh, EH1 3EG, UK; +44(0)1314655680; manx.neill@nhslothian.scot.nhs.uk), ref: 302033 |
| Condition | The identification and management of frailty in older surgical patients. The identification and prevention of delirium in older surgical patients. The identification and management of multimorbidity in older surgical patients. |
| Intervention | This study is observational, all interventions are surveys or validated tools that involve speaking with participants. The study will record details of participants' medical history, surgical history, comorbidities, laboratory results, and surgical risk score preoperatively. Two frailty assessments will be completed with the participant; a Clinical Frailty Scale and the Edmonton Frail Scale. If a hospital records an Electronic Frailty Index, then this will be recorded. After the participant has had surgery, details of intraoperative and immediate postoperative care will be recorded. If the participant remains in hospital, they will be followed up on days one, three, and seven postoperatively. On days one and three, a delirium screening tool (the 4AT) and a notes review for delirium trigger words will be used to identify delirium. On days three and seven, a postoperative morbidity score (POMS) will be used to identify postoperative morbidity. At four months postoperatively, participants will receive either an email or phone call for follow-up with the EQ-5D-5L and assess the number of days spent alive and at home. All patients who are 60 years or older, attending for surgery (day-case, elective and emergency) during up to two periods, of up to seven days, will be considered for inclusion. Patients will be given a participant information sheet (PIS) whilst waiting in the preoperative areas. 1. Patients will be identified from operating lists by clinical teams, given a PIS and referred to the research team if they are willing. They will be approached by the research team to discuss the study and consent. 2. Consent will be taken either on an electronic device using electronic signatures with declarations and tick boxes or a traditional paper consent form. 3. Pre-operative data collection Primarily through a review of the medical notes, with participant confirmation if necessary. Medical data, admission information, demographic and socioeconomic data will be sought. 4. Frailty assessments Four tools will be used to assess presence and severity of frailty. Two tools require participant involvement and two are passive. 4a. The Clinical Frailty Scale (CFS) provides a word and pictorial representation of the frailty syndrome and is recommended in the UK as a national screening tool for frailty, with prior use in surgical populations. The use of the CFS requires observation of the patient and a brief discussion of their activities of daily living. This will be completed by researchers before other frailty tools are seen to avoid confirmation bias. 4b. The Reported Edmonton Frailty Scale is brief, feasible and has also been used in surgical populations. It involves answering 10 short questions and participating in drawing a clock face. 4c. The electronic Frailty Index (eFI) uses the deficit accumulation model of frailty. It isn't available in all areas of the UK, it will be collected wherever it is currently recorded. 4d. The Hospital Frailty Risk Score can be calculated from HES data at discharge. We will report this, as it may be a useful automated method to highlight frailty to primary care colleagues. 5. Process of care data Primarily a notes review with participant confirmation if necessary. This will assess the process of preoperative assessment, modes of anaesthesia, use of a catheter and level of postoperative care. 6. Delirium The presence or absence of delirium will be assessed on days one and three if the participant remains in hospital. The 4AT (delirium assessment tool) or CAM ICU (Confusion Assessment Method Intensive Care Unit) and a review of nursing and medical notes of delirium trigger words will be used. The 4AT is a brief assessment tool requiring patients to answer six questions. CAM ICU is a brief 4 stage assessment tool for delirium that is validated for use in ICU. Notes review will be done manually by local researchers. These processes together will optimise our chances of detecting delirium. 7. Postoperative morbidity Postoperative Morbidity Survey (POMS) (with appropriate speciality specific modifications for cardiac and hip fracture patients) will be used on days three and seven if the participant remains in hospital. POMS is a tool used to assess postoperative morbidity. This is mainly a notes review but may require brief face to face interaction with the participant. 8. Quality of life (QoL) QoL will be assessed using the EQ-5D-5L questionnaire and a patient/carer estimate of days alive at home (DAH) via telephone interview or electronic email questionnaire. The EQ-5D-5L is a six question tool suitable for use over the telephone or electronic device. DAH is a patient preferred QoL outcome. We will cross check reported DAH with data linked by Hospital Episode Statistics/ Office for National Statistics/ Health and Social Care Wales/ Electronic Data Research and Innovation Services/ NHS Services Scotland (collected for DAOH). This will account for hospital length of stay and readmissions but not residence out of hospital but not at home (this specifically relies on patient/carer reports). Initial data linkage will be approximately four months after final enrolment, then one year mortality data will be linked at 12 months. Last participant contact will be four months after recruitment. The final data linkage will occur at 10 years when we will look for mortality. Data linkage will be carried out with NHS Digital, Health and Social Care Wales, NHS National Services Scotland and individual trusts as appropriate. The following will be collected: 1. Length of stay: Acute hospital stay and days alive and out of hospital (DAOH) within 30 and 90 days will be recorded. 2. Mortality: in hospital death, mortality at one year, two, five and ten years 3. Readmission: Readmission of participants within 30 days will be recorded 4. Discharge destination 5. Socio-economic status: post code will be linked with indices of deprivation Length of acute hospital stay (days) will be the primary outcome as it is expected to be affected by both medical complications and discharge planning issues. The other outcomes are important either as mechanistic explanations or as complementary patient-relevant metrics. |
| Intervention type | Other |
| Primary outcome measure | Length of acute hospital stay (days) after surgery collected via data linkage at the end of the study |
| Secondary outcome measures | 1. Planned surgical procedure taken from participant notes on day of surgery 2. Urgency of surgery (emergency, urgent, expedited, planned) taken from participant notes on day of surgery 3. Indication for surgery: cancer / non-cancer taken from participant notes on day of surgery 4. Co-morbidities from defined list taken from participant or participant notes on day of surgery 5. Count of regular medications from defined list taken from participant or participant notes on day of surgery 6. Age from participant notes on day of surgery 7. Sex at birth from participant on day of surgery 8. Gender from participant on day of surgery 9. Ethnicity from participant on day of surgery 10. Body mass index from participant notes/height/weight measurement on day of surgery 11. Most recent laboratory test results (measured within 6 weeks of admission) recorded on day of surgery: 11.1 Full blood count (Haemoglobin, red cell distribution width, white cell count (total), lymphocyte: neutrophil ratio 11.2 Creatinine & electrolyte 11.3 SARS-Cov-2 status (Positive/not positive (nasopharyngeal swab) 12. Surgery specific risk score: ASA status recorded on day of surgery 13. Surgery specific risk score: SORT version 2 score recorded on day of surgery 14. Comorbidity/multimorbidity measured using Charlson Comorbidity Index on day of surgery 15. Source of admission (Home (including level of support), residential home / retirement complex, care home) reported by participant or participant notes on day of surgery 16. Postcode (surrogate for socio-economic deprivation status) recorded from participant or participant notes on day of surgery 17. Highest education level (surrogate for a socioeconomic model) using UK Census 2011 list, recorded from participant or participant notes on day of surgery 18. Frailty recorded by Clinical Frailty Scale and Edmonton Frail Scale on day of surgery 19. Frailty recorded by electronic Frailty Index (eFI) recorded from hospital notes 20. Frailty recorded by Hospital Frailty Risk Score calculated from Hospital Episode Statistics at discharge. 21. Model of perioperative assessment (nurse-led, anaesthetist-led, physician-led) recorded from participant or participant notes on day of surgery 22. Mode of anaesthesia (general, local, regional, neuraxial anaesthesia) recorded from participant notes on day of surgery 23. Urinary catheterisation recorded from participant or participant notes on day of surgery 24. Level of postoperative care (ward, HDU, ICU) recorded from participant or participant notes on day of surgery 25. Delirium measured by 4AT and delirium trigger words from participant and participant notes respectively, reported on days one and three. 26. Postoperative morbidity measured by Postoperative Morbidity Score (general, cardiac and hip fracture) on days three and seven. 27. In hospital mortality measured by data linkage 28. Mortality measured via data linkage at one, two, five and ten years 29. Days alive and out of hospital measured through data linkage from discharge date and mortality within 30 and 90 days. 30. Readmission within 30 days measured through data linkage 31. Quality of life measured by EQ-5D-5L and EQ-VAS four months postoperatively by email or telephone survey. 32. Discharge deposition measured via data linkage after discharge 33. Quality of life measured by days alive at home, measured at four months postoperatively from participant and data linkage. |
| Overall study start date | 28/06/2021 |
| Overall study end date | 20/05/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 60 Years |
| Sex | Both |
| Target number of participants | 8,000 |
| Total final enrolment | 7794 |
| Participant inclusion criteria | 1. 60 years or older 2. Undergoing a surgical procedure on 21st-25th March 2022 (either elective or emergency) 3. Either have the capacity or have an appropriate consultee/personal legal representative to agree to participation on the participant's behalf |
| Participant exclusion criteria | 1. Very minor surgery eg. cataracts, endoscopy, tracheostomy 2. ASA VI |
| Recruitment start date | 21/03/2022 |
| Recruitment end date | 13/05/2022 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centre
Royal Devon and Exeter Hospital
Tremona Road
Exeter
EX2 5DW
United Kingdom
Exeter
EX2 5DW
United Kingdom
Sponsor information
University of Nottingham
University/education
University/education
University Park Campus
Nottingham
NG7 2RD
England
United Kingdom
| Phone | +44 (0)1159515151 |
|---|---|
| sponsor@nottingham.ac.uk | |
| Website | https://www.nottingham.ac.uk/ |
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
Research organisation
Royal College of Anaesthetists
Private sector organisation / Associations and societies (private and public)
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- RCoA
- Location
- United Kingdom
Frances and Augustus Newman Foundation
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Current publication and dissemination plan as of 04/06/2024: Planned publications in a high-impact peer-reviewed journal for descriptive and outcome data. Methodology paper reference: Swarbrick C, Poulton T, Martin P, Partridge J, Moppett IK; SNAP 3 Project Team. Study protocol for a national observational cohort investigating frailty, delirium and multimorbidity in older surgical patients: the third Sprint National Anaesthesia Project (SNAP 3). BMJ Open. 2023 Dec 21;13(12):e076803. doi: 10.1136/bmjopen-2023-076803. PMID: 38135325; PMCID: PMC10748966. Previous publication and dissemination plan: Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publically available repository. We intend that the data is available for seven years after final data linkage (2039) as per sponsor policy. All data will be anonymised and where group are small enough to allow possible identification, they will be grouped together to ensure anonymity. Participants consent form contains the fact their results will be shared with other researchers interested in this topic. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.0 | 28/05/2021 | 05/11/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 21/12/2023 | 27/12/2023 | Yes | No | |
| Results article | 06/01/2025 | 08/04/2025 | Yes | No |
Additional files
Editorial Notes
08/04/2025: Publication reference added.
04/06/2024: Publication and dissemination plan updated.
27/12/2023: Publication reference added.
18/08/2023: The following changes have been made:
1. The overall study end date was changed from 31/10/2022 to 20/05/2022 and the plain English summary was updated accordingly.
2. The Intention to publish date was changed from 01/04/2023 to 01/01/2025.
24/10/2022: The total final enrolment was added.
30/08/2022: A scientific contact has been added.
09/08/2022: The following changes were made to the trial record:
1. The study hypothesis was changed.
2. The recruitment end date was changed from 25/03/2022 to 13/05/2022.
3. The overall end date was changed from 01/08/2022 to 31/10/2022.
4. The target number of participants was changed from 12,000 to 8,000.
5. The plain English summary was updated to reflect these changes.
05/11/2021: Trial's existence confirmed by Wales REC 7
