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Strengthening Health Systems for Persons With Traumatic Spinal Cord Injury in South Africa and Sweden

Strengthening Health Systems for Persons With Traumatic Spinal Cord Injury in South Africa and Sweden: a Protocol for a Longitudinal Study of Processes and Outcomes

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03437850
Enrollment
200
Registered
2018-02-19
Start date
2017-04-15
Completion date
2020-06-30
Last updated
2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries

Brief summary

A traumatic spinal cord injury (TSCI) often causes an unprecedented change in functioning by altering bodily structure and function. More specifically, the direct consequences of TSCI to the motor, sensory and autonomic nervous system not only challenge an individual's independency but also the ability to make a positive adjustment to life after injury. In line with this, TSCI survivors often experience threats to their livelihood and becoming integrated members of society. Health systems therefore need to be ready to respond to the myriad of challenges following a TSCI by providing access to specialized and comprehensive services. The provision of specialized care in a time-sensitive manner has shown to be crucial for survival and recovery of functioning after a traumatic spinal cord injury (TSCI). However, little is known about the provision of TSCI care in different international contexts; information which is required for strengthening policy and practice.

Detailed description

Like many unforeseen medical emergencies, a TSCI could lead to early death in the absence of essential emergency and acute care. Hence, the single most important indicator of the quality of medical care is reflected in short- and long-term mortality. However, in order to improve survival after TSCI, it is also important to identify factors and processes of routine practice related to mortality. This could be accomplished by examining the extent to which processes of care reflect international guidelines and standards. These guidelines specifically stress the importance of a systematic approach towards the management of TSCI, which include specialized and comprehensive care that is delivered in a multi-disciplinary manner. More specifically, established success factors of TSCI healthcare have proven to include appropriate emergency management (e.g. transfer logistics to trauma unit), early spinal surgery and admission to specialist units, as well as multidisciplinary care. As a collective, literature has shown that a systematic approach towards the management of TSCI leads to a reduction in mortality, secondary complications and re-hospitalizations, as well as better functional outcomes. In Sweden, a systematic approach towards the management of TSCI was initiated around the 1970's. A number of studies investigating the acute management and mortality after TSCI found better aligned processes of care, and significantly greater survival, in Sweden, compared with a non-systematic approach to care followed in Greece. More specifically, transfer logistics from the accident scene to a specialized trauma unit, key therapeutic interventions, and timing of spinal surgery were better aligned to the international guidelines for the acute management of adults with SCI. In addition, numerous societal services, such as vocational rehabilitation, modifications of living conditions and workplace insurance, are provided to survivors of TSCI to enhance their independence and societal participation. Unlike Sweden, South Africa had yet to fully implement a systematic healthcare approach to TSCI management. Access to specialized healthcare services is not only a historic problem in South Africa, but it is further exacerbated by the lack of resources. Only one specialized SCI unit is available in South Africa, serving around 8 million people in the Western Cape Province. With the high incidence of TSCI in South Africa, mainly high risk TSCI patients (e.g. those in need of stabilizing spinal surgery) get access to specialized care at the SCI unit. In contrast, those not prioritized for treatment at the specialized SCI unit are treated at hospitals, including both secondary and tertiary level of care, providing non-specialized SCI health care. The common occurrence of non-specialized care of TSCI survivors in South Africa is alarming, especially as such care has shown to be related to a high mortality rate and the occurrence of preventable secondary complications. To improve the outcome of TSCI in South Africa, there is a crucial need to audit the nature and timing of essential processes of care and model their relationship with mortality, complications and long-term outcomes. Furthermore, given the low one-year mortality in Sweden, a comparison of processes of care between Sweden and South Africa could provide empirical evidence pointing to processes which could be modified. As a first step to strengthening the management guidelines for TSCI care in South Africa, the overarching aim of this study is to explore health-care processes and outcomes of TSCI care in South Africa and Sweden. Specific aims are to: 1) describe acute processes of TSCI care in South Africa and Sweden in comparison to international guidelines, 2) determine acute- and long-term outcomes of TSCI care, including survival status, secondary complications and functioning in South Africa and Sweden and 3) identify predictors for survival, secondary complications and functioning 12 months post-injury in South Africa and Sweden.

Interventions

OTHERUsual care

Care as usual, in terms of processes and outcomes, will be collected for all participants in both cohorts

Sponsors

Medical Research Council, South Africa
CollaboratorOTHER
Karolinska Institutet
CollaboratorOTHER
Karolinska University Hospital
CollaboratorOTHER
University of the Western Cape
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years

Inclusion criteria

* A TSCI defined as a sudden loss of voluntary muscle strength, sensation and autonomic functions below the level of injury, which will vary depending on neurological level of injury and extent of impairment, but must include altered sacral sensation; * The injury must result in persisting impairment (i.e. not just a concussion) after emergence from neurogenic shock, which generally occurs within the first 24-72 hours after injury; * Abnormal imaging, such as with Magnetic Resonance Imaging scan or multi-slice Computed Tomography scan; * 18 years of age; * Residents of one of the two study settings; * Those admitted to the government-funded hospitals providing SCI care; * Those consenting to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
Change in neurological classification from the end of acute care to one-year after injury according to the American Spinal Injury Association Impairment ScaleOne year after injury onsetNeurological status using the ASIA scale (A-E)
Mortalityat the end of acute hospital care (approximately six weeks from admission)To determine the mortality rate at the end of acute care
One-year mortalityone year after injuryTo determine the mortality rate after traumatic spinal cord injury one-year after injury onset
Prevalence of pressure ulcersacute care prevalence (within a six-week period approximately)To determine the prevalence and grade of pressure ulcers during acute care
Change in neurological classification from baseline to the end of acute care according to the American Spinal Injury Association Impairment ScaleEnd of acute care (within a six-week period approximately)Neurological status using the ASIA scale (A-E)

Secondary

MeasureTime frameDescription
Change in activity limitations from the end of acute care to one-year after injury according to the Spinal Cord Independence Measure IIIOne-year after injury onsetChange in activity limitations from the end of acute care (baseline) to one-year after injury according to the Spinal Cord Independence Measure III
Change in health-related quality of life from acute care admission to end of acute care hospitalisation using the EQ-5D measureAt the end of acute care (approximately six weeks)Change in health-related quality of life from acute care admission to end of acute care hospitalisation using the EQ-5D measure
Change in health-related quality of life between the end of acute care hospitalisation and one-year after injury onset using the EQ-5D measureone-year after injury onsetChange in health-related quality of life between the end of acute care hospitalisation and one-year after injury onset using the EQ-5D measure
Change in activity limitations from acute care admission to end of acute admission according to the Spinal Cord Independence Measure IIIAfter acute care (approximately 6 weeks post injury)Change in activity limitations according to Spinal Cord Independence Measure III

Countries

South Africa

Contacts

Primary ContactConran Joseph, PhD
cjoseph@uwc.ac.za+27723719276
Backup ContactAnthea Rhoda, PhD
arhoda@uwc.ac.za+27219592542

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026