SurgeryTCPNCT03593330
Neurosurgical Transitional Care Programme
A study testing Transitional Care Programme in people with Surgery and Brain Tumor, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
Readmissions increasingly serve as a metric of hospital performance, inviting quality improvement initiatives in both medicine and surgery. Recently, a readmission reduction program in the United States was associated with significantly shorter length of stay, earlier discharge, and reduced 30-day readmission after… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgery, Brain Tumor, Brain Tumor, Recurrent
- What is being tested?
- Transitional Care Programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 May 2019to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients are eligible for the TCP if scheduled for elective neurological surgery (including spinal surgery performed by an orthopedic surgeon) and were expected to have a discharge disposition to home.
Who cannot join
- Patients with an anticipated discharge to a facility other than home
- Patients with an anticipated discharge to home who are then discharged to a facility other than home will be excluded from the statistical analysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transitional Care Services: A Quality and Safety Process Improvement Programme in Neurosurgery
Readmissions increasingly serve as a metric of hospital performance, inviting quality improvement initiatives in both medicine and surgery. Recently, a readmission reduction program in the United States was associated with significantly shorter length of stay, earlier discharge, and reduced 30-day readmission after elective neurosurgery. These results underscore the importance of patient education and surveillance after hospital discharge, and it would be beneficial to test whether the same approach yields beneficial results in a different health system, the NHS. In this study, the investigators will replicate the Transitional Care Program (TCP) with the goal of decreasing length of stay, improving discharge efficiency, and reducing readmissions in neurosurgical patients by optimizing patient education and post-discharge surveillance.
Read the detailed description
Discharge Program Process Abbreviations: AA: administrative assistant; MRN: medical record number; OT: occupational therapy; PT: physical therapy; and TCT = Transitional Care Team.
CLINIC (pre-enrolment)
- Patient has clinic visit with surgeon and is identified for surgery
- Surgeon identifies that the patient is eligible to participate in the program and consents the patient for enrolment.
- Patients will be given a written information sheet on the program, and will have the opportunity to receive the information via email as well.
- Their consent will be obtained in clinic; the use of interpreters will be used for individuals with special communication needs.
AFTER CLINIC
- Once individuals consent to be randomised into the study, their MRN will be given to the TCP nurse, who will randomise the patient into the control or intervention group using a random number generator.
- Patients randomised to the TCP will be given a pre-determined discharge date when they are called to schedule their operation. The anticipated discharge date will be determined by each surgeon's expected length of stay per procedure.
- AA provides brief intro to patient about the discharge pilot, including need for family member to be present to take patient home after appointment is complete. The surgery and discharge appointments are then booked.
- AA sends surgical letter (with anticipated length of stay and discharge appointment date/time) and discharge pilot postcard to patient via email or mail
- AA enters case and discharge information into NSU Discharge Calendar
- Transitional Care Team (TCT) checks NSU Discharge Calendar daily for scheduled cases and discharge appointments
ADMISSION (TCT)
- TCT monitors operating theatre regularly for post-op pilot patients and visits daily
- TCT updates Safety Round white boards with all discharge appointment information
- TCT sends daily dept. email, including PT/OT, with following day's discharge appointment details
ADMISSION (INPATIENT/OUTPATIENT TEAMS)
- Patient is deemed appropriate for impending discharge by neurosurgery team
- TCT updates Safety Rounds white board and discusses discharge checklist with care team.
- Inpatient team completes discharge summary
- Inpatient team completes take-away medication list by 4pm one day prior to discharge appointment
- Inpatient team rationalises the need for further blood tests (as part of standard medical treatment, not for study purposes).
- Inpatient team confirms PT/OT is complete
- Inpatient team completes discharge checklist and puts in letter tray in TCP Nurse office for collection
POST-DISCHARGE APPOINTMENT
- Staff nurse or ward sister discharges patient
- TCT pulls discharge medications from pharmacy for appointments
- Healthcare assistant or staff nurse transports patient to discharge appointment
- Discharge appointment checklist completed by TCT for appointment
- Volunteer transports patient to hospital exit or Discharge Lounge
AFTER POST-DISCHARGE APPOINTMENT
- TCT/volunteer scans signed discharge appointment checklist into medical record
- TCT/volunteer records data in the spreadsheet
- TCT/volunteer shreds checklists
- TCT communicates any outstanding issues to primary teams
- Patient is asked to complete a patient satisfaction survey which will be sent via post and email. A second request will be sent at one week and two weeks post discharge.
FOLLOW-UP PHONE CALLS
- After completion of post-discharge appointments, TCT makes follow-up phone calls
- Call template is completed
- Call template is scanned into medical record
- All outstanding issues will be signed out to the primary teams by the TCT
Outcome measures will be collected through:
Intake forms Longitudinal data collection from hospital medical records and patient satisfaction surveys.
Data collected will be 30-day unplanned hospital re-admissions (to the same institution as the index operation) and length of hospital stay, the latter of which will be evaluated continuously by the number of hours of the initial hospitalisation. Time of discharge (with an early discharge defined as before 12:00 PM) will also be recorded.
- Conditions
- Surgery, Brain Tumor, Brain Tumor, Recurrent, Brain Pathology, Spinal Diseases, Spinal Stenosis
- Being tested
- Transitional Care Programme
- Keywords
- Transitional Care, Discharge Planning, Readmission, Elective Neurosurgery, Elective Spinal Surgery, Elective Brain Surgery, Transitional Care Program, TCP
- Medical subject headings
- Brain Neoplasms, Spinal Diseases, Spinal Stenosis, Trigeminal Neuralgia, Hydrocephalus, Aneurysm, Spinal Fractures, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transitional Care ProgrammeOther
Also called Discharge Planning
These patients will receive a pre-admission overview of their surgery, an anticipated discharge date, and a pre-scheduled discharge appointment to set patient expectations for a shorter hospitalization. On the day of discharge, the patient and his or her caregiver will attend an extended discharge appointment with a TCP-trained nurse. Finally, patients will receive a surveillance phone call 48 hours after discharge.
| Study group | Role | What they receive |
|---|---|---|
| Transitional Care Programme | Experimental | The primary intervention of the Transitional Care Programme (TCP) will be additional patient education, framing of expectations for the hospital course and length of stay, coordinated team preparation for discharge, a dedicated discharge appointment, and a follow up phone call. Receives: Other: Transitional Care Programme |
| Standard of Care | No intervention | Patients are admitted without a pre-determined discharge date. They do not receive a dedicated discharge appointment, and will not receive a follow up phone call 48 hours after discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Hospital Stay
Time from admission until discharge (reported in hours)
Measured: From time of hospital admission until the time of first hospital discharge or time of death from any cause, whichever came first. Assessed up to 4 months post-admission.
Secondary outcomes (4)
Hospital Readmission
Unplanned Readmission
Measured: From the time of hospital discharge from the original admission until 30 days after hospital discharge
Discharge before 12:00pm
Early morning discharge (between 00:00 and 11:59)
Measured: This is assessed on the date of discharge from time 00:00 to time 23:59. The actual time of discharge or time of death from any cause, whichever came first, will be noted. Assessed up to 4 months post-admission.
Cost
Total cost of hospital admission, transitional care programme, and readmission
Measured: The cost of the hospital admission will be calculated for the time frame from the initial hospital admission until 30 days after hospital discharge, or time of death from any cause.
Patient Satisfaction scores based on a single survey provided to the patient at the time of discharge.
5-point Likert-scale scores will be analyzed from a single patient satisfaction survey that is provided to the patient at the time of discharge. This survey was reported previously by Robertson et al. (Journal of Neurosurgery, 2017). The patient will have 2 weeks to complete the survey. Scores will assess patient satisfaction with 1 being the least satisfied and 5 being the most satisfied. Scores will be averaged for analysis and reporting.
Measured: From the time of hospital discharge from the original admission up until 2 weeks after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start30 May 2019
- Primary completion18 Aug 2019
- Study completion30 Aug 2019
Why it stopped: Early data showed an improvement in length of stay and patient satisfaction, but the nursing time that had been provided for free was subsequently withdrawn, and it was necessary to stop the trial before sufficient data had been collected.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomised into two groups: standard of care or Transitional Care Programme (TCP)
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Harvard Medical School (HMS and HSDM)
- Responsible party
- Sponsor
- Investigators
- Edward McKintosh, FRCS(SN) PhD, Principal investigator, Barts Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593330
- Sponsor's protocol ID
- IRAS238850
- Other IDs
- ReDA No: 012315
- Acronym
- TCP
- Status last verified
- Apr 2025
- First submitted
- 5 Jun 2018
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Robertson FC, Logsdon JL, Dasenbrock HH, Yan SC, Raftery SM, Smith TR, Gormley WB. Transitional care services: a quality and safety process improvement program in neurosurgery. J Neurosurg. 2018 May;128(5):1570-1577. doi: 10.3171/2017.2.JNS161770. Epub 2017 Jul 14.
PubMed 28707992Jones CE, Hollis RH, Wahl TS, Oriel BS, Itani KM, Morris MS, Hawn MT. Transitional care interventions and hospital readmissions in surgical populations: a systematic review. Am J Surg. 2016 Aug;212(2):327-35. doi: 10.1016/j.amjsurg.2016.04.004. Epub 2016 Jun 1.
PubMed 27353404Verhaegh KJ, MacNeil-Vroomen JL, Eslami S, Geerlings SE, de Rooij SE, Buurman BM. Transitional care interventions prevent hospital readmissions for adults with chronic illnesses. Health Aff (Millwood). 2014 Sep;33(9):1531-9. doi: 10.1377/hlthaff.2014.0160.
PubMed 25201657
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transitional Care Services: A Quality and Safety Process Improvement Programme in Neurosurgery
- ClinicalTrials.gov ID
- NCT03593330
- Acronym / sponsor ID
- TCP / IRAS238850
- Conditions
- Surgery, Brain Tumor, Brain Tumor, Recurrent, Brain Pathology, Spinal Diseases, Spinal Stenosis
- Keywords
- Transitional Care, Discharge Planning, Readmission, Elective Neurosurgery, Elective Spinal Surgery, Elective Brain Surgery, Transitional Care Program, TCP
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early data showed an improvement in length of stay and patient satisfaction, but the nursing time that had been provided for free was subsequently withdrawn, and it was necessary to stop the trial before sufficient data had been collected.
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Harvard Medical School (HMS and HSDM)
- Study start
- 30 May 2019 (actual)
- Primary completion
- 18 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 20 Jul 2018 (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.
Readmissions increasingly serve as a metric of hospital performance, inviting quality improvement initiatives in both medicine and surgery. Recently, a readmission reduction program in the United States was associated with significantly shorter length of stay, earlier discharge, and reduced 30-day readmission after elective neurosurgery. These results underscore the importance of patient education and surveillance after hospital discharge, and it would be beneficial to test whether the same approach yields beneficial results in a different health system, the NHS. In this study, the investigators will replicate the Transitional Care Program (TCP) with the goal of decreasing length of stay, improving discharge efficiency, and reducing readmissions in neurosurgical patients by optimizing patient education and post-discharge surveillance.
Detailed description
Discharge Program Process Abbreviations: AA: administrative assistant; MRN: medical record number; OT: occupational therapy; PT: physical therapy; and TCT = Transitional Care Team.
CLINIC (pre-enrolment)
- Patient has clinic visit with surgeon and is identified for surgery
- Surgeon identifies that the patient is eligible to participate in the program and consents the patient for enrolment.
- Patients will be given a written information sheet on the program, and will have the opportunity to receive the information via email as well.
- Their consent will be obtained in clinic; the use of interpreters will be used for individuals with special communication needs.
AFTER CLINIC
- Once individuals consent to be randomised into the study, their MRN will be given to the TCP nurse, who will randomise the patient into the control or intervention group using a random number generator.
- Patients randomised to the TCP will be given a pre-determined discharge date when they are called to schedule their operation. The anticipated discharge date will be determined by each surgeon's expected length of stay per procedure.
- AA provides brief intro to patient about the discharge pilot, including need for family member to be present to take patient home after appointment is complete. The surgery and discharge appointments are then booked.
- AA sends surgical letter (with anticipated length of stay and discharge appointment date/time) and discharge pilot postcard to patient via email or mail
- AA enters case and discharge information into NSU Discharge Calendar
- Transitional Care Team (TCT) checks NSU Discharge Calendar daily for scheduled cases and discharge appointments
ADMISSION (TCT)
- TCT monitors operating theatre regularly for post-op pilot patients and visits daily
- TCT updates Safety Round white boards with all discharge appointment information
- TCT sends daily dept. email, including PT/OT, with following day's discharge appointment details
ADMISSION (INPATIENT/OUTPATIENT TEAMS)
- Patient is deemed appropriate for impending discharge by neurosurgery team
- TCT updates Safety Rounds white board and discusses discharge checklist with care team.
- Inpatient team completes discharge summary
- Inpatient team completes take-away medication list by 4pm one day prior to discharge appointment
- Inpatient team rationalises the need for further blood tests (as part of standard medical treatment, not for study purposes).
- Inpatient team confirms PT/OT is complete
- Inpatient team completes discharge checklist and puts in letter tray in TCP Nurse office for collection
POST-DISCHARGE APPOINTMENT
- Staff nurse or ward sister discharges patient
- TCT pulls discharge medications from pharmacy for appointments
- Healthcare assistant or staff nurse transports patient to discharge appointment
- Discharge appointment checklist completed by TCT for appointment
- Volunteer transports patient to hospital exit or Discharge Lounge
AFTER POST-DISCHARGE APPOINTMENT
- TCT/volunteer scans signed discharge appointment checklist into medical record
- TCT/volunteer records data in the spreadsheet
- TCT/volunteer shreds checklists
- TCT communicates any outstanding issues to primary teams
- Patient is asked to complete a patient satisfaction survey which will be sent via post and email. A second request will be sent at one week and two weeks post discharge.
FOLLOW-UP PHONE CALLS
- After completion of post-discharge appointments, TCT makes follow-up phone calls
- Call template is completed
- Call template is scanned into medical record
- All outstanding issues will be signed out to the primary teams by the TCT
Outcome measures will be collected through:
Intake forms Longitudinal data collection from hospital medical records and patient satisfaction surveys.
Data collected will be 30-day unplanned hospital re-admissions (to the same institution as the index operation) and length of hospital stay, the latter of which will be evaluated continuously by the number of hours of the initial hospitalisation. Time of discharge (with an early discharge defined as before 12:00 PM) will also be recorded.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomised into two groups: standard of care or Transitional Care Programme (TCP)
| Arm | Type | Receives |
|---|---|---|
| Transitional Care Programme | Experimental | Other: Transitional Care ProgrammeThe primary intervention of the Transitional Care Programme (TCP) will be additional patient education, framing of expectations for the hospital course and length of stay, coordinated team preparation for discharge, a dedicated discharge appointment, and a follow up phone call. |
| Standard of Care | No intervention | –Patients are admitted without a pre-determined discharge date. They do not receive a dedicated discharge appointment, and will not receive a follow up phone call 48 hours after discharge. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients are eligible for the TCP if scheduled for elective neurological surgery (including spinal surgery performed by an orthopedic surgeon) and were expected to have a discharge disposition to home.
Key exclusion criteria (2 listed)
- Patients with an anticipated discharge to a facility other than home
- Patients with an anticipated discharge to home who are then discharged to a facility other than home will be excluded from the statistical analysis
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 |
|---|---|---|
| Transitional Care ProgrammeAlso: Discharge PlanningThese patients will receive a pre-admission overview of their surgery, an anticipated discharge date, and a pre-scheduled discharge appointment to set patient expectations for a shorter hospitalization. On the day of discharge, the patient and his or her caregiver will attend an extended discharge appointment with a TCP-trained nurse. Finally, patients will receive a surveillance phone call 48 hours after discharge. | Other | Transitional Care Programme |
Primary outcome
Length of Hospital Stay
Time frame: From time of hospital admission until the time of first hospital discharge or time of death from any cause, whichever came first. Assessed up to 4 months post-admission.
Time from admission until discharge (reported in hours)
4 secondary outcomes
Hospital Readmission
Time frame: From the time of hospital discharge from the original admission until 30 days after hospital discharge
Discharge before 12:00pm
Time frame: This is assessed on the date of discharge from time 00:00 to time 23:59. The actual time of discharge or time of death from any cause, whichever came first, will be noted. Assessed up to 4 months post-admission.
Cost
Time frame: The cost of the hospital admission will be calculated for the time frame from the initial hospital admission until 30 days after hospital discharge, or time of death from any cause.
Patient Satisfaction scores based on a single survey provided to the patient at the time of discharge.
Time frame: From the time of hospital discharge from the original admission up until 2 weeks after discharge
Results and safety
The study was stopped early (reason given: Early data showed an improvement in length of stay and patient satisfaction, but the nursing time that had been provided for free was subsequently withdrawn, and it was necessary to stop the trial before sufficient data had been collected.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Background: PubMed 28707992Robertson FC, Logsdon JL, Dasenbrock HH, Yan SC, Raftery SM, Smith TR, Gormley WB. Transitional care services: a quality and safety process improvement program in neurosurgery. J Neurosurg. 2018 May;128(5):1570-1577. doi: 10.3171/2017.2.JNS161770. Epub 2017 Jul 14.
- Background: PubMed 27353404Jones CE, Hollis RH, Wahl TS, Oriel BS, Itani KM, Morris MS, Hawn MT. Transitional care interventions and hospital readmissions in surgical populations: a systematic review. Am J Surg. 2016 Aug;212(2):327-35. doi: 10.1016/j.amjsurg.2016.04.004. Epub 2016 Jun 1.
- Background: PubMed 25201657Verhaegh KJ, MacNeil-Vroomen JL, Eslami S, Geerlings SE, de Rooij SE, Buurman BM. Transitional care interventions prevent hospital readmissions for adults with chronic illnesses. Health Aff (Millwood). 2014 Sep;33(9):1531-9. doi: 10.1377/hlthaff.2014.0160.
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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. This study is not recruiting at the moment.
Edward McKintosh, FRCS(SN) PhD principal investigator
Barts Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transitional Care Programme in people with Surgery and Brain Tumor, run by Barts & The London NHS Trust at 1 site in United Kingdom.
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: stopped early, as of the sponsor's last update on 2 May 2025. 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 United Kingdom. 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?
The study was stopped early (reason given: Early data showed an improvement in length of stay and patient satisfaction, but the nursing time that had been provided for free was subsequently withdrawn, and it was necessary to stop the trial before sufficient data had been collected.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Hospital Stay (time frame: From time of hospital admission until the time of first hospital discharge or time of death from any cause, whichever came first. Assessed up to 4 months post-admission.). 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 NCT03593330, which also lists 3 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 2 May 2025.