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

January 8, 2021 updated by: Schweizer Paraplegiker Forschung

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

273

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Luzern
      • Nottwil, Luzern, Switzerland, 6207
        • Schweizer Paraplegiker Forschung

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention group

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
Educational modules on bladder, bowel and skin-care, and pain management will be provided to participating GPs by Spinal Cord Injury specialists
Other: 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
No Intervention: Control 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average difference in total score of Doctor's Opinions on Collaboration (DOC)
Time Frame: Change from baseline to 12 and 24 months post intervention
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
Time Frame: Change from baseline to 12 and 24 months post intervention
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
Time Frame: Change in overall satisfaction scores from baseline to 12 and 24 months post intervention
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
Time Frame: Change from baseline to 12 months and 24 months post intervention
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
Time Frame: Change from baseline to 12 and 24 months post intervention
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
Time Frame: Change from baseline to 12 and 24 months post intervention
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
Time Frame: Change from baseline to 12 and 24 months post intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Schweizer Paraplegiker Forschung

Investigators

  • Principal Investigator: Armin Gemperli, PhD, Schweizer Paraplegiker Forschung

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

August 26, 2019

First Submitted That Met QC Criteria

August 27, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

January 12, 2021

Last Update Submitted That Met QC Criteria

January 8, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCICO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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