Nervous System Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Heart and Blood Diseases

Wounds and Injuries

Musculoskeletal Diseases

Mouth and Tooth Diseases

Rare Diseases

Neuralgia

Neoplasm Metastasis

Recurrence

Aneurysm

Fractures, Bone

Brain Diseases

Hydrocephalus

Spinal Diseases

Constriction, Pathologic

Brain Neoplasms

Trigeminal Neuralgia

Spinal Stenosis

Cysts

Spinal Fractures

Spinal Cord Neoplasms

Spinal Curvatures

Central Nervous System Neoplasms

Nervous System Neoplasms

Central Nervous System Diseases

Peripheral Nervous System Diseases

Neuromuscular Diseases

Pain

Neurologic Manifestations

Bone Diseases

Trigeminal Nerve Diseases

Facies

Facial Neuralgia

Facial Nerve Diseases

Mouth Diseases

Stomatognathic Diseases

Cranial Nerve Diseases

Spinal Injuries

Back Injuries

Spinal Cord Diseases

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.

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.

Transitional Care Programme

Alex Alamri, MBBS

Edward McKintosh, FRCS(SN),PhD

Edward McKintosh, FRCS,PhD

Christopher Uff, PhD,FRCS

Faith C Robertson, BS

William B Gormley, MD,MPH,MBA

Amin Elyas, MBBS,FRCS

Edward McKintosh, FRCS(SN) PhD

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.

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.

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

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.

Neurosurgical Transitional Care Programme

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

Time from admission until discharge (reported in hours)

Early morning discharge (between 00:00 and 11:59)

Total cost of hospital admission, transitional care programme, and readmission

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.

Brigham and Women's Hospital

Harvard Medical School (HMS and HSDM)

Barts & The London NHS Trust

Spinal Cord Compression

Spinal Neoplasms

Neoplastic Processes

Bone Neoplasms

Central Nervous System Depressants

All Drugs and Chemicals

Antineoplastic Agents

Anesthetics

Melphalan

Antineoplastic Agents, Alkylating

Alkylating Agents

Immunosuppressive Agents

Immunologic Factors

Subjects recruited to this study will receive intra-arterial injections of chemotherapy (melphalan) in the branches of the arteries feeding the metastatic spinal tumor. Subjects will receive general anesthesia or conscious sedation. A catheter will be guided using X-ray from the femoral artery at the top of the leg to the arteries of the spine. A dye will be injected through the catheter to show the arteries in greater detail. The chemotherapy is then injected into the tumor. We will inject the maximum systemic dose adjusted to white blood count and platelet count. Subjects will undergo three cycles of chemotherapy three to six weeks apart.

Patients will undergo a minimally invasive procedure called spinal angiography. This procedure will identify the arteries feeding the tumor causing cord compression and will determine whether chemotherapy can be safely infused.

The chemotherapy will be infused via a tiny soft plastic tube (called "microcatheter") at the tumor site over approximately 30 minutes.

The drug of choice is melphalan (trade name Alkeran) at a maximum dose of 16mg/m2, adjusted for white cell count, platelet count and renal function.

We will perform up to three intra-arterial chemotherapy treatments in 3-6 week intervals, based on the results of complete blood counts.

Melphalan (intra-arterial infusion)

Athos Patsalides

Metastatic malignant tumors comprise the vast majority of spinal tumors in adults. The most devastating complication of spinal metastatic disease (SMD) is invasion of the spinal canal and compression of the spinal cord or the nerve roots of the cauda equina, resulting in a clinical entity known as cord compression that manifests with progressive loss of motor function and sensation in the legs, as well as bladder and bowel incontinence.

The treatment of spinal metastases is mostly palliative with the goals of improving or maintaining neurologic function, achieving local tumor control, and spinal stability. Most patients with spinal metastatic disease are currently treated effectively with radiation therapy and/or surgery with good results. There are however certain limitations in the current treatment of SMD. Radiation therapy has two important limitations: 1) if the targeted SMD is in close proximity the spinal cord, delivery of high radiation doses is contraindicated as it may cause radiation-induced damage to the spinal cord (myelopathy, and 2) there is limit on the cumulative amount of radiation dose, which means that recurrent tumors may not be amenable to repeat radiation therapy. As far spinal surgery is concerned, the main limitation is that some patients are not fit for surgery because of medical co-morbidities.

This phase I clinical research trial will test the hypothesis that a new minimally invasive treatment called spinal intra-arterial chemotherapy (SIAC) can be safely applied in patients with SMD.

To date, there is no effective systemic therapy for spinal metastases, and the goal of treatment is to achieve local control of the tumor. Despite advances in radiation therapy, there is still a subgroup of patients that cannot be effectively treated with radiation because of close proximity of the tumor to the spinal cord. In addition, in cases of recurrent tumors, some patients cannot be re-treated because they reached the maximum allowed radiation dose. Surgery is the alternative treatment for these patients, but some tumors do recur after surgery while some patients have comorbidities that make surgery a high-risk procedure.

Based on our prior experience with selective IA chemotherapy for the treatment of ocular retinoblastoma and the high local control rates achieved with selective IA injection of chemotherapy in recurrent limb melanoma (limb infusion and limb perfusion) we expect that spinal intra-arterial chemotherapy with selective injection of Melphalan in the arteries feeding the metastatic disease is feasible and safe and may prove beneficial in achieving local control of the spinal tumor, preventing neurological compromise from cord compression. This minimally invasive approach can be used in patients in whom radiation therapy and surgery are contra-indicated and essentially have no other treatment options.

Intra-arterial Chemotherapy for Spinal Metastases

Selective Intra-arterial Chemotherapy in the Treatment Strategy of Metastatic Spinal Disease

Weill Medical College of Cornell University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neurosurgical Transitional Care Programme	NCT03593330	Surgery Brain Tumor Brain Tumor, Re... Brain Pathology Spinal Diseases Spinal Stenosis Spinal Fusion Trigeminal Neur... Hydrocephalus Fusion of Spine Aneurysm SPINAL Fracture Chiari; Net Skull Injuries Brain Cancer Brain Metastase... Brain Diseases Brain Lesion Brain Cyst Spinal Curvatur... Spinal Instabil... Spinal Cord Neo...	Transitional Ca...	-	Barts & The London NHS Trust
Neurosurgical Transitional Care Programme	NCT03593330	Surgery Brain Tumor Brain Tumor, Re... Brain Pathology Spinal Diseases Spinal Stenosis Spinal Fusion Trigeminal Neur... Hydrocephalus Fusion of Spine Aneurysm SPINAL Fracture Chiari; Net Skull Injuries Brain Cancer Brain Metastase... Brain Diseases Brain Lesion Brain Cyst Spinal Curvatur... Spinal Instabil... Spinal Cord Neo...	Transitional Ca...	-	Barts & The London NHS Trust
Intra-arterial Chemotherapy for Spinal Metastases	NCT01637766	Spinal Diseases Spinal Metastas... Spinal Tumors	Melphalan (intr...	18 Years - 80 Years	Weill Medical College of Cornell University

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