- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07015099
- Original Trial
Complications Associated With Delayed Admission to Spinal Injury Unit
Delayed Transfer to Spinal Injury Unit Post Acute Traumatic Spinal Cord Injury: A Comprehensive Assessment on Health Impacts and Rehabilitation
Study Overview
Status
Conditions
Detailed Description
Pressure ulcers (PUs) are one of many challenging complications in patients with spinal cord injury (SCI). PUs impact on length of rehabilitation, activities of daily living, participation in physical and social activities, health-related quality of life and increases health care costs significantly. Globally, approximately 32% of patients with SCI experience PUs and this may reflect inadequate prevention and management strategies.
Complications including PUs can occur at any time following SCI from the acute phase, the rehabilitation phase and during the long term follow up period, however the highest PU risk is in the acute phase. Older age, decreased general health status and prolonged periods of immobilisation increases risk of PUs in the acute period. Specialised SCI rehabilitation centres are recommended to reduce the overall length of stay (LOS), mortality and reduce complications following SCI.
Variations exist globally between time to admission for specialist rehabilitation from onset of acute traumatic spinal cord injury with averages of 7.3-377 days reported in the literature. Some identified barriers to specialised SCI rehabilitation unit admission include lack of bed availability, shortage of skilled staff, inadequate finance, physical and environmental barriers resulting in increased wait times for specialist rehabilitation. Time to admission to specialist rehabilitation unit greater than one month have been shown to increase the occurrence of complications, including PUs at the time of rehabilitation admission.
A review conducted in 2003 by Bagnall et al., evaluated 22 articles which compared early admission to a specialist SCI unit to late admission and/or no admission. Whilst favourable neurological recovery was suggested for those who were admitted to a specialist centre compared to late or no admission, all the studies included in the review were deemed to be of poor quality, conducted in the 1980/1990s and, in most cases, could not separate the time of referral to an SCI centre to the time of admission.
In 2015, the All Party Parliamentary Group on SCI undertook an inquiry into the impact of nationwide SCI centres and the people they support. They reported that from 118 patients waiting for admission to a SCI unit, contact with an SCI unit on the same day as the injury was only made for 9 patients. The median time from injury to contact with a specialist centre was 6 days and the median time from injury to referral to a SCI centre was 8 days. On further investigation, 36% of cases required additional information before admission suitability, 24% of cases were due to bed availability, 20% of cases were accepted but were later deemed clinically unfit for transfer, 10% were deemed suitable for outreach or out-patient services and the final 10% of cases were deemed 'other'.
However, this is not the case in every part of the UK. In a recent 2023/24 report from The Queen Elizabeth National Spinal Injuries Unit (Glasgow), it was stated that there was no waiting list for admission to the SCI unit for that period, and of those patients referred to the centre, 58% of patients were admitted within one week. It was reported that the mean admission time to the SCI unit was 29 days, compared to the mean admission time for other spinal centres in the UK being 2-3 months.
The effect of delayed admission to a SCI centre for both the individual with injury and the surrounding family can be profound. Not only are patients often in a high state of uncertainty about their possible prognosis but they can also feel extremely overwhelmed by all the unanswered questions. For those who are waiting to be admitted to a SCI unit, a fear of losing their 'window of opportunity', of which may potentially alter their expected functional recovery, can be seen amongst the patients, highlighted in the evidence above. Delayed admission can also lead to a heightened risk of complications such as PUs, contractures and infections, secondary to an increased hospital stay and decreased functional recovery.
An initial service evaluation from January 2016 and December 2018 has been undertaken by clinicians on the MCSI (RJAH) in the last year to begin to investigate the impact of delayed referral to the MCSI on the prevalence of PUs, it found via multivariate analysis that age, sex and wait time to admission for specialist SCI rehabilitation were significant risk factors for the development of PUs. Here it is proposed to build on this study by undertaking a comprehensive analysis using the last decade of data, to evaluate the impact of delayed admission on SCI rehabilitation and neurological recovery.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Karina Wright
- Phone Number: +441691404022
- Email: karina.wright1@nhs.net
Study Locations
-
-
-
Oswestry, United Kingdom, Sy10 7AG
- The Robert Jones and Agnes Hunt Orthopaedic Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
All eligible patients will be included, of both sexes.
Exclusion Criteria:
Patients younger than 18 years
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relationship between wait time to admission and complications
Time Frame: 7 months
|
Descriptive statistics and hypothesis-testing methods will be used to analyse primary data.
Central tendencies (arithmetic mean, median and frequencies) and measures of variability (standard deviation and interquartile ranges) will be obtained.
To test the hypothesis of the difference in frequency (sex) and difference in arithmetic means (age), chi-squared test and t-test will be used respectively.
Mann-Whitney U-test will be used to test the hypothesis of difference in wait time to transfer for specialist SCI rehabilitation.
Multivariable linear and generalised linear regression will be undertaken to identify the potential predictors associated with complication risk, patient recovery and hospital stay from delayed admission to the MCSI rehabilitation centre.
|
7 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RL1 917
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spinal Cord Injury
-
Ecole Polytechnique Fédérale de LausanneRecruitingChronic Spinal Cord Injury | Spinal Cord Injury (SCI) | Spinal Cord Injury | SCI - Spinal Cord Injury | SCI | Subacute Spinal Cord InjurySwitzerland
-
Lian-Cing Yan, MSPTNot yet recruitingSpinal Cord Injury | Spinal Cord Stimulation | Spinal Cord Injury/Damage | Spinal Cord Injury Thoracic | Spinal Cord Stimulation (SCS) | Spinal Cord Injury T1-L2 | Epidural Electrical StimulationTaiwan
-
Xuanwu Hospital, BeijingBeijing Pins Medical Co., Ltd; Beijing Xinzhida Neural Technology Co., Ltd; Hangzhou...RecruitingSpinal Cord Injury | Motor Deficits | Gait Impairment | Gait Training | Spinal Cord Injury Cervical | Spinal Cord Injuries (SCI) | Motor Impairment | Spinal Cord Injury, Chronic | Spinal Cord Injury Thoracic | Spinal Cord Injury (Quadraplegia)China
-
Taipei Veterans General Hospital, TaiwanThe Industrial Technology Research InstituteUnknownSpinal Cord Injuries | Complete Spinal Cord Injury | Incomplete Spinal Cord InjuryTaiwan
-
Chang Gung Memorial HospitalNot yet recruitingSpine Injury | Complete Spinal Cord Injury | Incomplete Spinal Cord Injury | Cord Injury, Spinal | Cord Infarction Spinal
-
University of FloridaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedSCI - Spinal Cord Injury | Incomplete Spinal Cord InjuryUnited States
-
Jill M. Wecht, Ed.D.Icahn School of Medicine at Mount SinaiRecruitingBlood Pressure | Spinal Cord Injuries | SCI - Spinal Cord Injury | Blood Pressure Disorders | Traumatic Spinal Cord Injury | Acute Spinal Cord Injury | Neuromodulation | Spinal Cord StimulationUnited States
-
NervGen PharmaCompletedSpinal Cord Injuries | Chronic Spinal Cord Injury | Subacute Spinal Cord InjuryUnited States
-
MetroHealth Medical CenterNational Institute of Neurological Disorders and Stroke (NINDS); Case Western...RecruitingSpinal Cord Injuries | Spinal Cord Injury at C5-C7 Level | Spinal Cord Injury CervicalUnited States
-
Anne BrydenNational Institute of Neurological Disorders and Stroke (NINDS); Case Western... and other collaboratorsRecruitingSpinal Cord Injuries | Spinal Cord Injury at C5-C7 Level | Spinal Cord Injury Cervical | Spinal Cord Injury at C5-C7 Level With Complete Lesion | Spinal Cord Injury at C5-C7 Level With Incomplete LesionUnited States