TCP: Neurosurgical Transitional Care Programme

Sponsor

Barts & The London NHS Trust (Other)

Overall Status

Unknown status

CT.gov ID

NCT03593330

Collaborator

Brigham and Women's Hospital (Other), Harvard Medical School (HMS and HSDM) (Other)

400

Enrollment

Location

Arms

Anticipated Duration (Months)

16.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
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	Other: Transitional Care Programme	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients will be randomised into two groups: standard of care or Transitional Care Programme (TCP)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.

Primary Purpose:

Health Services Research

Official Title:

Transitional Care Services: A Quality and Safety Process Improvement Programme in Neurosurgery

Actual Study Start Date :

Apr 15, 2018

Anticipated Primary Completion Date :

Apr 15, 2019

Anticipated Study Completion Date :

Apr 15, 2020

Arms and Interventions

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.	Other: Transitional Care Programme 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: Discharge Planning
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.

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.

Other: Transitional Care Programme

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:

Discharge Planning

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.

Outcome Measures

Primary Outcome Measures

Length of Hospital Stay [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)

Secondary Outcome Measures

Hospital Readmission [From the time of hospital discharge from the original admission until 30 days after hospital discharge]
Unplanned Readmission
Discharge before 12:00pm [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.]
Early morning discharge (between 00:00 and 11:59)
Cost [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.]
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. [From the time of hospital discharge from the original admission up until 2 weeks after 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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