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

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ClinicalTrials.gov Identifier: NCT03437850
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Collaborators:
Medical Research Council, South Africa
Karolinska Institutet
Karolinska University Hospital
Information provided by (Responsible Party):
Dr Conran Joseph, University of the Western Cape

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.

Condition or disease Intervention/treatment
Spinal Cord Injuries Other: Usual care

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.


Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : April 15, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
South African cohort Other: Usual care
Care as usual, in terms of processes and outcomes, will be collected for all participants in both cohorts
Swedish Cohort Other: Usual care
Care as usual, in terms of processes and outcomes, will be collected for all participants in both cohorts



Primary Outcome Measures :
  1. Mortality [ Time Frame: at the end of acute hospital care (approximately six weeks from admission) ]
    To determine the mortality rate at the end of acute care

  2. One-year mortality [ Time Frame: one year after injury ]
    To determine the mortality rate after traumatic spinal cord injury one-year after injury onset

  3. Prevalence of pressure ulcers [ Time Frame: acute care prevalence (within a six-week period approximately) ]
    To determine the prevalence and grade of pressure ulcers during acute care

  4. Prevalence of pressure ulcers [ Time Frame: One year after injury onset ]
    To determine the prevalence of pressure ulcers one-year after injury

  5. Change in neurological classification from baseline to the end of acute care according to the American Spinal Injury Association Impairment Scale [ Time Frame: End of acute care (within a six-week period approximately) ]
    Neurological status using the ASIA scale (A-E)

  6. Change in neurological classification from the end of acute care to one-year after injury according to the American Spinal Injury Association Impairment Scale [ Time Frame: One year after injury onset ]
    Neurological status using the ASIA scale (A-E)


Secondary Outcome Measures :
  1. Change in activity limitations from acute care admission to end of acute admission according to the Spinal Cord Independence Measure III [ Time Frame: After acute care (approximately 6 weeks post injury) ]
    Change in activity limitations according to Spinal Cord Independence Measure III

  2. Change in activity limitations from the end of acute care to one-year after injury according to the Spinal Cord Independence Measure III [ Time Frame: One-year after injury onset ]
    Change in activity limitations from the end of acute care (baseline) to one-year after injury according to the Spinal Cord Independence Measure III

  3. Change in health-related quality of life from acute care admission to end of acute care hospitalisation using the EQ-5D measure [ Time Frame: At 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

  4. Change in health-related quality of life between the end of acute care hospitalisation and one-year after injury onset using the EQ-5D measure [ Time Frame: one-year after injury onset ]
    Change in health-related quality of life between the end of acute care hospitalisation and one-year after injury onset using the EQ-5D measure



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
All newly-injured individuals with traumatic spinal cord injury for at least a one-year period within a defined catchment area.
Criteria

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

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): NCT03437850


Contacts
Contact: Conran Joseph, PhD +27723719276 cjoseph@uwc.ac.za
Contact: Anthea Rhoda, PhD +27219592542 arhoda@uwc.ac.za

Locations
South Africa
University of the Western Cape Recruiting
Cape Town, South Africa
Contact: Conran Joseph, PhD    +27723719276    cjoseph@uwc.ac.za   
Sponsors and Collaborators
University of the Western Cape
Medical Research Council, South Africa
Karolinska Institutet
Karolinska University Hospital

Responsible Party: Dr Conran Joseph, Lecturer (PhD), University of the Western Cape
ClinicalTrials.gov Identifier: NCT03437850     History of Changes
Other Study ID Numbers: BM/16/3/24
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: May be made available upon reasonable request.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System