Clinical trial NCT03593330: Neurosurgical Transitional Care Programme
Official title: Transitional Care Services: A Quality and Safety Process Improvement Programme in Neurosurgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgery
Brain Tumor
Brain Tumor, Recurrent
Brain Pathology
Spinal Diseases
Spinal Stenosis
Spinal Fusion
Trigeminal Neuralgia
Hydrocephalus
Fusion of Spine
Aneurysm
SPINAL Fracture
Chiari; Net
Skull Injuries
Brain Cancer
Brain Metastases
Brain Diseases
Brain Lesion
Brain Cyst
Spinal Curvature
Spinal Instability
Spinal Cord Neoplasms
Keywords: Transitional Care
Discharge Planning
Readmission
Elective Neurosurgery
Elective Spinal Surgery
Elective Brain Surgery
Transitional Care Program
TCP
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Harvard Medical School (HMS and HSDM)
First posted: 2018-07-20
Enrollment: 242
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomised into two groups: standard of care or Transitional Care Programme (TCP)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of Hospital Stay
timeFrame: 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:
measure: Hospital Readmission
timeFrame: From the time of hospital discharge from the original admission until 30 days after hospital discharge
measure: Discharge before 12:00pm
timeFrame: 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.
measure: Cost
timeFrame: 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.
measure: Patient Satisfaction scores based on a single survey provided to the patient at the time of discharge.
timeFrame: From the time of hospital discharge from the original admission up until 2 weeks after discharge
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Bart's Health NHS Trust
Study officials:
affiliation: Barts Health
name: Edward McKintosh, FRCS(SN) PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.