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

Spinal Cord Injuries Clinical Trial

— SCICO  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04071938
• Other study ID #: SCICO
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: October 1, 2022

Study information

• Verified date: January 2021
• Source: Schweizer Paraplegiker Forschung
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 273
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Other:
• Teaching to GPs
Educational modules on bladder, bowel and skin-care, and pain management will be provided to participating GPs by Spinal Cord Injury specialists
• Site visits to GP practices
Visits by specialized nurses to the participating GPs at their practices to support the establishment of specialized care on-site

Locations

Country	Name	City	State
Switzerland	Schweizer Paraplegiker Forschung	Nottwil	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
Schweizer Paraplegiker Forschung

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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