Shared Responsibility Between General Practitioners and Highly Specialized Hospitals in Spinal Cord Injury (SCICO)
8. januar 2021 oppdatert 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.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
273
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Luzern
-
Nottwil, Luzern, Sveits, 6207
- Schweizer Paraplegiker Forschung
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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 |
Educational modules on bladder, bowel and skin-care, and pain management will be provided to participating GPs by Spinal Cord Injury specialists
Visits by specialized nurses to the participating GPs at their practices to support the establishment of specialized care on-site
|
|
Ingen inngripen: 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) |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Average difference in total score of Doctor's Opinions on Collaboration (DOC)
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Physicians' satisfaction
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Armin Gemperli, PhD, Schweizer Paraplegiker Forschung
Publikasjoner og nyttige lenker
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. februar 2019
Primær fullføring (Forventet)
1. oktober 2022
Studiet fullført (Forventet)
1. oktober 2022
Datoer for studieregistrering
Først innsendt
26. august 2019
Først innsendt som oppfylte QC-kriteriene
27. august 2019
Først lagt ut (Faktiske)
28. august 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. januar 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. januar 2021
Sist bekreftet
1. januar 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SCICO
Plan for individuelle deltakerdata (IPD)
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NEI
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Nei
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