Clinical trial NCT04071938: Shared Responsibility Between General Practitioners and Highly Specialized Hospitals in Spinal Cord Injury
Official title: Shared Responsibility Between General Practitioners and Highly Specialized Hospitals in Complex Chronic Conditions: the Case of Spinal Cord Injury in a Nationwide Intervention Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Schweizer Paraplegiker Forschung
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Average difference in total score of Doctor's Opinions on Collaboration (DOC)
timeFrame: Change from baseline to 12 and 24 months post intervention
measure: Average difference in total score of Modified Spinal Cord Injury Secondary Conditions Scale (SCI-SCS) score
timeFrame: Change from baseline to 12 and 24 months post intervention
Secondary outcomes:
measure: Physicians' satisfaction
timeFrame: Change in overall satisfaction scores from baseline to 12 and 24 months post intervention
measure: Average difference in the number of inpatient hospitalization
timeFrame: Change from baseline to 12 months and 24 months post intervention
measure: Average difference in number of patients visits to a specialist or a SCI center
timeFrame: Change from baseline to 12 and 24 months post intervention
measure: Average difference in subscore on pressure sores
timeFrame: Change from baseline to 12 and 24 months post intervention
measure: Average difference in subscore on UTIs
timeFrame: Change from baseline to 12 and 24 months post intervention
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Schweizer Paraplegiker Forschung
state: Luzern
Study officials:
affiliation: Schweizer Paraplegiker Forschung
name: Armin Gemperli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.