- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07820852
Clinical Governance of Home Care and 30-Day Stability (CG-HOME-DSS4)
Clinical Governance of Home Care and 30-Day Home Stability: A Prospective Observational Study in the Health and Social Care District No. 4 of Barletta
This prospective observational study evaluates the organization, quality, and outcomes of home care provided by the Health and Social Care District No. 4 of Barletta, Azienda Sanitaria Locale BT, Italy. It includes patients receiving integrated home care, scheduled general practitioner home visits, or temporary home care during the study period.
The study will assess timeliness of care activation, care characteristics, and 30-day home stability. Home stability is defined as the absence of emergency department visits and unplanned hospital admissions within 30 days. The collected data will be used to identify organizational and clinical factors associated with outcomes and to support quality-improvement activities in community-based care.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
This single-center prospective observational study is part of a clinical governance program for home care services in the Health and Social Care District No. 4 of Barletta, Azienda Sanitaria Locale BT, Italy. The study concerns three community-based care pathways: integrated home care (ADI), scheduled general practitioner home care (ADP), and temporary home care (ADT).
Eligible care episodes activated during the study period will be identified through routinely collected health service data. No experimental treatment or additional clinical procedure will be assigned by the study. Patients will continue to receive care according to standard clinical practice and their individualized care plans.
The primary outcome is home stability at 30 days, defined as the absence of emergency department visits and unplanned hospital admissions during the 30 days following activation of home care. Additional variables will include the type and intensity of home care, time from request to activation, emergency department visits without admission, unplanned hospital admissions, interruptions or reactivations of care, and selected organizational indicators.
Data will be obtained from the regional health information systems and the administrative and clinical information sources available to the participating district. The analysis will describe the study population, care processes, and 30-day outcomes and will explore differences across care pathways and levels of care complexity. Findings will support multidisciplinary audit and quality-improvement actions aimed at strengthening continuity, appropriateness, and safety of home-based care.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Ilaria Alicino, MD
- Telefonnummer: +39 0883 577810
- E-post: dss4@aslbat.it
Studiesteder
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-
Barletta-Andria-Trani
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Barletta, Barletta-Andria-Trani, Italia, 76121
- Health and Social Care District No. 4 of Barletta, Azienda Sanitaria Locale BT
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Ta kontakt med:
- Ilaria Alicino, MD
- Telefonnummer: 0883-577810
- E-post: dss4@aslbat.it
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Age 18 years or older.
- Resident of, or receiving primary care within, Health and Social Care District No. 4 of Barletta.
- Activation of an Integrated Home Care (ADI), Scheduled General Practitioner Home Care (ADP), or Temporary Home Care (ADT) episode during the study enrollment period.
- Availability of the administrative and clinical data required to assess care processes and 30-day outcomes.
Exclusion Criteria:
- Age younger than 18 years.
- Home care episode initiated outside the study enrollment period.
- Records that cannot be reliably linked across the data sources required for 30-day follow-up.
- Duplicate records relating to the same participant and the same home care episode.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Integrated Home Care (ADI)
Standard multidisciplinary integrated home care provided according to an individualized care plan.
|
Standard scheduled home care provided by the participant's general practitioner.
|
|
Scheduled GP Home Care (ADP)
Participants receiving scheduled home visits from their general practitioner.
|
Standard scheduled home care provided by the participant's general practitioner.
|
|
Temporary Home Care (ADT)
Participants receiving temporary home care because they are temporarily unable to attend an outpatient healthcare setting.
|
Standard temporary home care provided to participants who are temporarily unable to attend an outpatient healthcare setting.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
30-Day Home Stability
Tidsramme: From home care activation through 30 days
|
Percentage of participants with no emergency department visit and no unplanned hospital admission within 30 days after activation of home care.
|
From home care activation through 30 days
|
|
30-Day Home Stability
Tidsramme: From home care activation through 30 days
|
Percentage of participants with no emergency department visit and no unplanned hospital admission within 30 days after activation of home care.
The numerator is the number of participants without either event, and the denominator is the total number of participants evaluable at 30 days.
|
From home care activation through 30 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Emergency Department Visits Within 30 Days
Tidsramme: From home care activation through 30 days
|
Percentage of participants with at.gmail least one emergency department visit, without subsequent hospital admission, within 30 days after activation of home care.
|
From home care activation through 30 days
|
|
Unplanned Hospital Admissions Within 30 Days
Tidsramme: From home care activation through 30 days
|
Percentage of participants with at least one unplanned hospital admission within 30 days after activation of home care.
|
From home care activation through 30 days
|
|
Time to Home Care Activation
Tidsramme: From home care request to home care activation, assessed up to 30 days
|
Number of days between the documented request for home care and the activation of the home care episode.
|
From home care request to home care activation, assessed up to 30 days
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Domenico Spinazzola, Azienda Sanitaria Locale BT
- Studiestol: Ilaria Alicino, MD, Azienda Sanitaria Locale BT
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
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Andre studie-ID-numre
- ASLBT-DSS4-ADI-2026
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