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

8 januari 2021 uppdaterad av: 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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

273

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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
Övrig: 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
Övrig: 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
Inget ingripande: 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)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Average difference in total score of Doctor's Opinions on Collaboration (DOC)
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Physicians' satisfaction
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Schweizer Paraplegiker Forschung

Utredare

  • Huvudutredare: Armin Gemperli, PhD, Schweizer Paraplegiker Forschung

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 februari 2019

Primärt slutförande (Förväntat)

1 oktober 2022

Avslutad studie (Förväntat)

1 oktober 2022

Studieregistreringsdatum

Först inskickad

26 augusti 2019

Först inskickad som uppfyllde QC-kriterierna

27 augusti 2019

Första postat (Faktisk)

28 augusti 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 januari 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 januari 2021

Senast verifierad

1 januari 2021

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • SCICO

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

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