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Neurosurgical Transitional Care Programme (TCP)

Primary Purpose

Surgery, Brain Tumor, Brain Tumor, Recurrent

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Transitional Care Programme
Sponsored by
Barts & The London NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Surgery focused on measuring Transitional Care, Discharge Planning, Readmission, Elective Neurosurgery, Elective Spinal Surgery, Elective Brain Surgery, Transitional Care Program, TCP

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bart's Health NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Transitional Care Programme

Standard of Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Length of Hospital Stay
Time from admission until discharge (reported in hours)

Secondary Outcome Measures

Hospital Readmission
Unplanned Readmission
Discharge before 12:00pm
Early morning discharge (between 00:00 and 11:59)
Cost
Total cost of hospital admission, transitional care programme, and readmission
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.

Full Information

First Posted
June 5, 2018
Last Updated
July 10, 2018
Sponsor
Barts & The London NHS Trust
Collaborators
Brigham and Women's Hospital, Harvard Medical School (HMS and HSDM)
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1. Study Identification

Unique Protocol Identification Number
NCT03593330
Brief Title
Neurosurgical Transitional Care Programme
Acronym
TCP
Official Title
Transitional Care Services: A Quality and Safety Process Improvement Programme in Neurosurgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 15, 2018 (Actual)
Primary Completion Date
April 15, 2019 (Anticipated)
Study Completion Date
April 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barts & The London NHS Trust
Collaborators
Brigham and Women's Hospital, Harvard Medical School (HMS and HSDM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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) published by Robertson et al.(Journal of Neurosurgery 2017) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomised into two groups: standard of care or Transitional Care Programme (TCP)
Masking
None (Open Label)
Masking Description
All eligible patients will be consented to participate in the study. If they consent, a non-clinician study team member will randomise the patient into the control or intervention arm. Thereafter, all members of the care team will be notified of the patient's allocation in order to deliver the TCP.
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transitional Care Programme
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Transitional Care Programme
Other Intervention Name(s)
Discharge Planning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Length of Hospital Stay
Description
Time from admission until discharge (reported in hours)
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.
Secondary Outcome Measure Information:
Title
Hospital Readmission
Description
Unplanned Readmission
Time Frame
From the time of hospital discharge from the original admission until 30 days after hospital discharge
Title
Discharge before 12:00pm
Description
Early morning discharge (between 00:00 and 11:59)
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.
Title
Cost
Description
Total cost of hospital admission, transitional care programme, and readmission
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.
Title
Patient Satisfaction scores based on a single survey provided to the patient at the time of discharge.
Description
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.
Time Frame
From the time of hospital discharge from the original admission up until 2 weeks after discharge

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alex Alamri, MBBS
Phone
07779363461
Email
Bagher.Alamri@bartshealth.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward McKintosh, FRCS(SN) PhD
Organizational Affiliation
Barts Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bart's Health NHS Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward McKintosh, FRCS(SN),PhD
Phone
07779363461
Email
Edward.McKintosh@bartshealth.nhs.uk
First Name & Middle Initial & Last Name & Degree
Alex Alamri, MBBS
Phone
07779363461
Email
Bagher.Alamri@bartshealth.nhs.uk
First Name & Middle Initial & Last Name & Degree
Edward McKintosh, FRCS,PhD
First Name & Middle Initial & Last Name & Degree
Christopher Uff, PhD,FRCS
First Name & Middle Initial & Last Name & Degree
Alex Alamri, MBBS
First Name & Middle Initial & Last Name & Degree
Faith C Robertson, BS
First Name & Middle Initial & Last Name & Degree
William B Gormley, MD,MPH,MBA
First Name & Middle Initial & Last Name & Degree
Amin Elyas, MBBS,FRCS

12. IPD Sharing Statement

Citations:
PubMed Identifier
28707992
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.
Results Reference
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PubMed Identifier
27353404
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.
Results Reference
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PubMed Identifier
25201657
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.
Results Reference
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Neurosurgical Transitional Care Programme

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