Shared Responsibility Between General Practitioners and Highly Specialized Hospitals in Spinal Cord Injury

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Shared Responsibility Between General Practitioners and Highly Specialized Hospitals in Complex Chronic Conditions: the Case of Spinal Cord Injury in a Nationwide Intervention Study

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Other: Teaching to GPs
* Other: Site visits to GP practices


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physicians GPs practicing in medium to large group practice The practice is wheelchair accessible and remote to SCI specialized centers Proficiency certificate in ultrasonography Patients: Diagnosed with traumatic or non-traumatic, sensory or motor complete or incomplete, chronic SCI 18 years or older Permanently reside in Switzerland Reside farther than 25 minutes driving distance from a specialized SCI center Understand German, English, Italian Informed consent Additionally in treatment group: Patients with chronic SCI Living in the region of a participating GP irrespective if they visit the participating primary care practice. Additionally in control group: individuals with SCI who live outside the catchment areas 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>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 | Other: Teaching to GPs<br>* Educational modules on bladder, bowel and skin-care, and pain management will be provided to participating GPs by Spinal Cord Injury specialists<br>Other: Site visits to GP practices<br>* Visits by specialized nurses to the participating GPs at their practices to support the establishment of specialized care on-site<br>|
| No Intervention: Control group<br>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) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |