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

NCT04071938 | Unknown

• 1 other identifier: SCICO
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Physicians' satisfaction

  Change in overall satisfaction scores from baseline to 12 and 24 months post intervention

• Average difference in the number of inpatient hospitalization

  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

  Change from baseline to 12 and 24 months post intervention

• Average difference in subscore on pressure sores

  Change from baseline to 12 and 24 months post intervention

• Average difference in subscore on UTIs

  Change from baseline to 12 and 24 months post intervention

Study Arms (2)

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

Other: Teaching to GPs; Other: Site visits to GP practices

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)

Interventions

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

Intervention group

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

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Schweizer Paraplegiker Forschung: lead

Study Sites (1)

Schweizer Paraplegiker Forschung

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 34869940 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Armin Gemperli, PhD

  Schweizer Paraplegiker Forschung

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: August 28, 2019
• Study Start: February 1, 2019
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)