Developing a ward round model able to achieve a safer and faster in-hospital course for general surgery patients, based on a daily meeting attended by all key professionals, and where key clinical information is discussed and decided upon, and actions' effectiveness and promptness monitored
| ISRCTN | ISRCTN13976096 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13976096 |
| ClinicalTrials.gov (NCT) | Nil Known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Barts Health NHS Trust |
| Funder | Investigator initiated and funded |
- Submission date
- 08/02/2021
- Registration date
- 28/04/2021
- Last edited
- 28/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The need for hospital beds available for patients requiring acute care is a long-lasting issue in the NHS. The aim of this study is to monitor the implementation of a service model based on ward round model able to achieve a safer and faster in-hospital course for general surgery patients, based on a daily meeting attended by all key professionals, and where key clinical information is discussed and decided upon, and actions' effectiveness and promptness are monitored.
Who can participate?
All patients admitted from January to December 2017 at the Department of General Surgery at the Royal London Hospital.
What does the study involve?
Patients do not experience any change in their care and are followed up from admission to 30 days after hospital discharge. Participants are made aware of the ongoing service improvement.
What are the possible benefits and risks of participating?
The SAFER Red2Green methodology had been in use in the NHS hospitals in other specialties for approximately two years before the start of the study. The study does not involve any change in patients’ care so there is no direct risk for the patients. The possible benefit for them is a more focused and structured multidisciplinary care made possible by additional time spent by the staff participating in the board round meetings.
Where is the study run from?
Blizard Institute, Barts and the London School of Medicine & Dentistry (UK)
When is the study starting and how long is it expected to run for?
November 2016 to April 2018
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Mr Roberto Valente (r.valente@ucl.ac.uk)
Mr Mohamed A. Thaha (m.a.thaha@qmul.ac.uk)
Contact information
Scientific
Largo Rosanna Benzi 10
Genoa
16632
Italy
| 0000-0002-1841-3802 | |
| Phone | +39 (0)3356003887 |
| r.valente@ucl.ac.uk |
Scientific
Blizard Institute, Barts and the London School of Medicine & Dentistry
Queen Mary, University of London
London
E1 1BB
United Kingdom
| Phone | +44 (0)203 594 1799 |
|---|---|
| m.a.thaha@qmul.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational before and after study |
| Secondary study design | Before and after study |
| Study type | Participant information sheet |
| Scientific title | Enhancing a safe general surgery patient flow by a modified 'SAFER Surgery Red2Green' multidisciplinary board round |
| Study acronym | SAFER-Surgery-R2G |
| Study objectives | The application of the "SAFER Surgery Red2Green" multidisciplinary board round safely enhances general surgery inpatient flow. |
| Ethics approval(s) | The project was commissioned by the hospital trust and approved by the Divisional and Service leading groups and discussed in the standard governance meetings throughout. No formal ethical approval was deemed necessary, given the study was designed as a service improvement exercise with no change in the direct clinical care. |
| Health condition(s) or problem(s) studied | Developing a ward round model able to achieve a safer and faster in-hospital course for general surgery patients |
| Intervention | This is a before-after study, comparing the year 2016 (pre-intervention) versus the year 2017 (post-intervention). The service improvement project was approved by the division of surgery and perioperative care, and is reported according to the SQUIRE 2.0 standards. The study is divided into three phases: 1. Clinical protocol definition 2. Feasibility study and protocol refinement 3. Pilot study 1. Clinical protocol definition The clinical protocol for the study was designed in November 2016 based on available evidence and experiences, Barts Health Trust policies and projects, and by adapting the SAFER R2G to the surgical environment. The general surgery departmental audit meeting attended by all grades of medical staff approved the preliminary protocol in December 2016, which had the following key principles: 1. Systematic communication of key care plan from the afternoon ward rounds by each surgical firm to the nurse in charge so that this information can be included in the evening handover to the night team 2. Daily (Monday to Friday) multi-disciplinary senior team board round at 10:00 AM addressing: 2.1. Updated key care plan aimed at early discharges 2.2. MDT appropriateness evaluation of each day 3. Twice-weekly attendance of the board round by the hospital management and site managers 4. Weekly review of delays 5. Three consultant surgeons and a specialist nurse led the project Study participants are not subject to any change in their respective care, and their follow-up is set from admission date to 30 days after hospital discharge. Participants are made aware of the ongoing service improvement. 2. Feasibility study The 3 months’ feasibility phase of the structured board rounds commenced in January 2017 and was chaired by the three consultant surgeons and specialist nurse leading the project. Monthly departmental audit meetings were used to provide progress reports to the entire department. All admissions to the general surgery ward from January 1st 2017 were included in this feasibility study, irrespective of the base specialty. This included some of the “outlier patients” who were under the care of vascular and trauma surgery, and orthopaedics, hosted in emergency in the general surgery ward due to bed shortage in the respective services. However, only general surgery consultants participated in the board rounds. The study team assessed the safety and feasibility of the project at weekly team meetings and made early revisions of the outcome measures. The final study protocol was presented to and approved at a consensus meeting at the departmental audit day. 3. Pilot study The 9-month pilot phase of the study was conducted from 01/04/2017 to 31/12/2017. The on-call consultant from the night before chaired the daily MDT board round so that this activity followed the post-emergency take ward rounds. The prospective audit of the MDT board round collated information on performance progress and attendance by different team members and of the communication of the daily surgical key care plan to the nurse in charge. The 12 months after-intervention period ended on 31/12/2017. Study of the interventions A set of primary and secondary measures were chosen to assess the impact of the SAFER Surg R2G model, while addressing its sustainability. These were monitored weekly, to ensure their accuracy and completeness. The researchers compared the 12 months before versus 12 months after intervention periods, pairing weekly values of the two groups to reduce the impact of seasonal changes in the demand. Statistical analysis The results are expressed as mean ± standard deviation, median, counts or percentages. The Shapiro-Wilk test was used to assess the normal distribution of continuous variables. Categorical variables were analysed with χ2 test or Fisher’s exact test when appropriate. Comparisons between continuous variables were performed with the Mann-Whitney-Wilcoxon rank-sum test. Cumulative probability of discharge was evaluated by using Kaplan-Meier product-limit estimator, with log-rank test to compare time-event curves. Statistical significance was assumed in each two-tailed test with p-value |
| Intervention type | Other |
| Primary outcome measure(s) |
Hospital stay and readmission outcome measures monitored weekly using the hospital Admission – Transfer – Discharge database for 12 months before versus 12 months after the intervention period: |
| Key secondary outcome measure(s) |
Monitored weekly using the hospital Admission – Transfer – Discharge database for 12 months before versus 12 months after the intervention period: |
| Completion date | 01/04/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 800 |
| Total final enrolment | 1986 |
| Key inclusion criteria | All admissions to the general surgery ward from January 1st to December 31st 2017 |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/01/2017 |
| Date of final enrolment | 31/12/2017 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Queen Mary, University of London
London
E1 1BB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 27/03/2023 | 28/03/2023 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Preprint results | 03/09/2021 | 13/01/2022 | No | No |
Editorial Notes
28/03/2023: Publication reference added.
13/01/2022: Preprint reference added.
28/04/2021: Trial's existence confirmed by Barts Health NHS Trust.