- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03593330
Neurosurgical Transitional Care Programme (TCP)
Transitional Care Services: A Quality and Safety Process Improvement Programme in Neurosurgery
Study Overview
Status
Conditions
- Brain Diseases
- Spinal Diseases
- Brain Cancer
- Brain Tumor
- Surgery
- Spinal Stenosis
- Aneurysm
- Fusion of Spine
- Brain Metastases
- Spinal Fusion
- Trigeminal Neuralgia
- Brain Tumor, Recurrent
- Hydrocephalus
- Spinal Cord Neoplasms
- Brain Lesion
- SPINAL Fracture
- Brain Pathology
- Spinal Instability
- Spinal Curvature
- Chiari; Net
- Skull Injuries
- Brain Cyst
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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London, United Kingdom
- Bart's Health NHS Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Transitional Care Programme
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.
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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.
Other Names:
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No Intervention: Standard of Care
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
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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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital Readmission
Time Frame: From the time of hospital discharge from the original admission until 30 days after hospital discharge
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Unplanned Readmission
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From the time of hospital discharge from the original admission until 30 days after hospital discharge
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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.
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Early morning discharge (between 00:00 and 11:59)
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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.
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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.
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Total cost of hospital admission, transitional care programme, and readmission
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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.
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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
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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.
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From the time of hospital discharge from the original admission up until 2 weeks after discharge
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Edward McKintosh, FRCS(SN) PhD, Barts Health
Publications and helpful links
General Publications
- Jones 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.
- 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.
- Verhaegh 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Bone Diseases
- Musculoskeletal Diseases
- Mouth Diseases
- Stomatognathic Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Neoplasms by Site
- Neoplasms
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Fractures, Bone
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Cranial Nerve Diseases
- Spinal Cord Diseases
- Trigeminal Nerve Diseases
- Facial Neuralgia
- Facial Nerve Diseases
- Back Injuries
- Spinal Injuries
- Spinal Stenosis
- Neuralgia
- Brain Neoplasms
- Brain Diseases
- Trigeminal Neuralgia
- Spinal Cord Neoplasms
- Hydrocephalus
- Spinal Diseases
- Spinal Fractures
- Spinal Curvatures
Other Study ID Numbers
- IRAS238850
- ReDA No: 012315 (Other Identifier: Joint Research Management Office)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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