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

Primary Purpose

Spinal Cord Injuries

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Teaching to GPs
Site visits to GP practices
Sponsored by
Schweizer Paraplegiker Forschung
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Schweizer Paraplegiker Forschung

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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

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)

Outcomes

Primary Outcome Measures

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)
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).

Secondary Outcome Measures

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.
Average difference in the number of inpatient hospitalization
Number of hospitalizations people with SCI had in 12 months period
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
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)
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)

Full Information

First Posted
August 26, 2019
Last Updated
January 8, 2021
Sponsor
Schweizer Paraplegiker Forschung
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1. Study Identification

Unique Protocol Identification Number
NCT04071938
Brief Title
Shared Responsibility Between General Practitioners and Highly Specialized Hospitals in Spinal Cord Injury
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Schweizer Paraplegiker Forschung

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
273 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Teaching to GPs
Intervention Description
Educational modules on bladder, bowel and skin-care, and pain management will be provided to participating GPs by Spinal Cord Injury specialists
Intervention Type
Other
Intervention Name(s)
Site visits to GP practices
Intervention Description
Visits by specialized nurses to the participating GPs at their practices to support the establishment of specialized care on-site
Primary Outcome Measure Information:
Title
Average difference in total score of Doctor's Opinions on Collaboration (DOC)
Description
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)
Time Frame
Change from baseline to 12 and 24 months post intervention
Title
Average difference in total score of Modified Spinal Cord Injury Secondary Conditions Scale (SCI-SCS) score
Description
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).
Time Frame
Change from baseline to 12 and 24 months post intervention
Secondary Outcome Measure Information:
Title
Physicians' satisfaction
Description
Questionnaire distributed to physicians in intervention and control group to measure the difference in the satisfaction with the collaboration between the health care providers.
Time Frame
Change in overall satisfaction scores from baseline to 12 and 24 months post intervention
Title
Average difference in the number of inpatient hospitalization
Description
Number of hospitalizations people with SCI had in 12 months period
Time Frame
Change from baseline to 12 months and 24 months post intervention
Title
Average difference in number of patients visits to a specialist or a SCI center
Description
Number of visits to SCI specialist of SCI center people with SCI had in 12 months period
Time Frame
Change from baseline to 12 and 24 months post intervention
Title
Average difference in subscore on pressure sores
Description
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)
Time Frame
Change from baseline to 12 and 24 months post intervention
Title
Average difference in subscore on UTIs
Description
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)
Time Frame
Change from baseline to 12 and 24 months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armin Gemperli, PhD
Organizational Affiliation
Schweizer Paraplegiker Forschung
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schweizer Paraplegiker Forschung
City
Nottwil
State/Province
Luzern
ZIP/Postal Code
6207
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34869940
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.
Results Reference
derived

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

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