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Neurosurgical Transitional Care Programme (TCP)

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ClinicalTrials.gov Identifier: NCT03593330
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Collaborators:
Brigham and Women's Hospital
Harvard Medical School
Information provided by (Responsible Party):
Barts & The London NHS Trust

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 Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated 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)
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 : April 15, 2018
Estimated Primary Completion Date : April 15, 2019
Estimated Study Completion Date : April 15, 2020

Resource links provided by the National Library of Medicine


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 Name: 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.



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Hospital Readmission [ Time Frame: From the time of hospital discharge from the original admission until 30 days after hospital discharge ]
    Unplanned Readmission

  2. 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. ]
    Early morning discharge (between 00:00 and 11:59)

  3. 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. ]
    Total cost of hospital admission, transitional care programme, and readmission

  4. 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 ]
    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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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03593330


Contacts
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Contact: Alex Alamri, MBBS 07779363461 Bagher.Alamri@bartshealth.nhs.uk

Locations
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United Kingdom
Bart's Health NHS Trust Recruiting
London, United Kingdom
Contact: Edward McKintosh, FRCS(SN),PhD    07779363461    Edward.McKintosh@bartshealth.nhs.uk   
Contact: Alex Alamri, MBBS    07779363461    Bagher.Alamri@bartshealth.nhs.uk   
Principal Investigator: Edward McKintosh, FRCS,PhD         
Sub-Investigator: Christopher Uff, PhD,FRCS         
Sub-Investigator: Alex Alamri, MBBS         
Sub-Investigator: Faith C Robertson, BS         
Sub-Investigator: William B Gormley, MD,MPH,MBA         
Sub-Investigator: Amin Elyas, MBBS,FRCS         
Sponsors and Collaborators
Barts & The London NHS Trust
Brigham and Women's Hospital
Harvard Medical School
Investigators
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Principal Investigator: Edward McKintosh, FRCS(SN) PhD Barts Health

Publications:
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Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT03593330     History of Changes
Other Study ID Numbers: IRAS238850
ReDA No: 012315 ( Other Identifier: Joint Research Management Office )
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Barts & The London NHS Trust:
Transitional Care
Discharge Planning
Readmission
Elective Neurosurgery
Elective Spinal Surgery
Elective Brain Surgery
Transitional Care Program
TCP
Additional relevant MeSH terms:
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Brain Neoplasms
Spinal Cord Neoplasms
Spinal Stenosis
Spinal Diseases
Spinal Curvatures
Trigeminal Neuralgia
Neuralgia
Hydrocephalus
Brain Diseases
Spinal Fractures
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Central Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Bone Diseases
Musculoskeletal Diseases
Trigeminal Nerve Diseases
Facial Neuralgia
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases
Spinal Injuries