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Clinical Governance of Home Care and 30-Day Stability (CG-HOME-DSS4)

10. september 2026 oppdatert av: Azienda Sanitaria Locale BT

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

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

Observasjonsmessig

Registrering (Antatt)

500

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Ilaria Alicino, MD
  • Telefonnummer: +39 0883 577810
  • E-post: dss4@aslbat.it

Studiesteder

    • Barletta-Andria-Trani
      • Barletta, Barletta-Andria-Trani, Italia, 76121
        • Health and Social Care District No. 4 of Barletta, Azienda Sanitaria Locale BT
        • Ta kontakt med:
          • Ilaria Alicino, MD
          • Telefonnummer: 0883-577810
          • E-post: dss4@aslbat.it

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

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

The study population will include consecutive adult patients receiving Integrated Home Care (ADI), Scheduled General Practitioner Home Care (ADP), or Temporary Home Care (ADT) within the Health and Social Care District No. 4 of Barletta during the enrollment period. Participants will be identified through routinely collected administrative and clinical healthcare data. Each individual will be counted once for enrollment purposes, while duplicate records relating to the same participant and care episode will be excluded.

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

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

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studieleder: Domenico Spinazzola, Azienda Sanitaria Locale BT
  • Studiestol: Ilaria Alicino, MD, Azienda Sanitaria Locale BT

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 (Antatt)

1. januar 2027

Primær fullføring (Antatt)

1. juli 2027

Studiet fullført (Antatt)

1. juli 2027

Datoer for studieregistrering

Først innsendt

10. september 2026

Først innsendt som oppfylte QC-kriteriene

10. september 2026

Først lagt ut (Faktiske)

15. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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