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It is an interventional study that aims to assess a new primary care model of collaboration between specialized centers and primary care physicians in Switzerland, in order to reduce morbidity and improve patients' and providers' experience with delivery of follow-up care in individuals with chronic spinal cord injury as compared to current best practice.
This model will lead to awareness, recognition and interactive communication between GPs and specialists and guidelines on the shared-role relationship.
The study interventions are educational modules on bladder, bowel, skin-care, and pain management which will be provided to participating GPs by Spinal Cord Injury specialists. In addition visits by specialized nurses to the participating GPs at their practices to support the establishment of specialized care on-site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Active Comparator | Physicians: 10 GPs from 10 practices who treat patient with Spinal cord injury (SCI) and 10 SCI specialists. Patients: 270 people with SCI within 25 minutes vehicle driving distance to the GP practices will be in the intervention group |
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| Control group | No Intervention | Physicians: 20 GPs who treat patient with SCI will not receive any intervention. They will be completing the questionnaire (DOC) and assessed for satisfaction with collaboration with the SCI specialist. Patients: 210 people with spinal cord injury outside the catchment area of the intervention group will be receiving usual care (no intervention) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teaching to GPs | Other | Educational modules on bladder, bowel and skin-care, and pain management will be provided to participating GPs by Spinal Cord Injury specialists |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average difference in total score of Doctor's Opinions on Collaboration (DOC) | DOC is a validated questionnaire covering organization, communication, professional expertise, image and knowing each other. It will be completed by GPs and SCI specialists. The DOC will be converted to an interval score and scaled from 0 to 100 with minimum and maximum score (0=completely agree, 100=completely disagree) | Change from baseline to 12 and 24 months post intervention |
| Average difference in total score of Modified Spinal Cord Injury Secondary Conditions Scale (SCI-SCS) score | Modified Spinal Cord Secondary Conditions Scale (SCI-SCS) targets secondary conditions associated with SCI composite endpoint, excluding diabetes mellitus and joint and muscle pain. Modified (SCI-SCS) includes 14 health conditions and chronic pain. Self reporting through questionnaires on pressure sores, urinary tract infections, spasticity, postural hypotension, bowel, and bladder problems, etc...). The rating scale uses a 4-point ordinal scale ranging from 0 (not experienced/insignificant problem never limiting activity) to 3 (significant/chronic problem). | Change from baseline to 12 and 24 months post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Physicians' satisfaction | Questionnaire distributed to physicians in intervention and control group to measure the difference in the satisfaction with the collaboration between the health care providers. | Change in overall satisfaction scores from baseline to 12 and 24 months post intervention |
| Average difference in the number of inpatient hospitalization |
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Inclusion Criteria:
Physicians
Patients:
Exclusion Criteria:
Patients:
- Acute SCI or during first rehabilitation phase - Congenital conditions leading to paraplegia or tetraplegia, including spina bifida - Neurodegenerative disorders such as multiple sclerosis and amyotrophic lateral sclerosis - Guillain-Barré syndrome
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| Name | Affiliation | Role |
|---|---|---|
| Armin Gemperli, PhD | Schweizer Paraplegiker Forschung | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schweizer Paraplegiker Forschung | Nottwil | Canton of Lucerne | 6207 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34869940 | Derived | Tomaschek R, Touhami D, Essig S, Gemperli A. Shared responsibility between general practitioners and highly specialized physicians in chronic spinal cord injury: Study protocol for a nationwide pragmatic nonrandomized interventional study. Contemp Clin Trials Commun. 2021 Nov 17;24:100873. doi: 10.1016/j.conctc.2021.100873. eCollection 2021 Dec. |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| Site visits to GP practices | Other | Visits by specialized nurses to the participating GPs at their practices to support the establishment of specialized care on-site |
|
Number of hospitalizations people with SCI had in 12 months period |
| Change from baseline to 12 months and 24 months post intervention |
| Average difference in number of patients visits to a specialist or a SCI center | Number of visits to SCI specialist of SCI center people with SCI had in 12 months period | Change from baseline to 12 and 24 months post intervention |
| Average difference in subscore on pressure sores | from Modified Spinal Cord Injury Secondary Conditions Scale (SCI-SCS)Subscore on pressure sores with a 4-point rating on severity, ranging from 0 (not experienced/insignificant problem never limiting activity) to 3 (significant/chronic problem) | Change from baseline to 12 and 24 months post intervention |
| Average difference in subscore on UTIs | from Modified Spinal Cord Injury Secondary Conditions Scale (SCI-SCS)Subscore on urinary tract infections (UTIs) with a 4-point rating on severity, ranging from 0 (not experienced/insignificant problem never limiting activity) to 3 (significant/chronic problem) | Change from baseline to 12 and 24 months post intervention |
| D014947 | Wounds and Injuries |