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

NCT ID: NCT04071938

Last Updated: 2021-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

273 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2022-10-01

Brief Summary

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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

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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.

Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Teaching to GPs

Intervention Type OTHER

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

Intervention Type OTHER

Visits by specialized nurses to the participating GPs at their practices to support the establishment of specialized care on-site

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)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schweizer Paraplegiker Forschung

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Armin Gemperli, PhD

Role: PRINCIPAL_INVESTIGATOR

Schweizer Paraplegiker Forschung

Locations

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Schweizer Paraplegiker Forschung

Nottwil, Canton of Lucerne, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 34869940 (View on PubMed)

Other Identifiers

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SCICO

Identifier Type: -

Identifier Source: org_study_id

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