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

10 september 2026 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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

Observationeel

Inschrijving (Geschat)

500

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Ilaria Alicino, MD
  • Telefoonnummer: +39 0883 577810
  • E-mail: dss4@aslbat.it

Studie Locaties

    • Barletta-Andria-Trani
      • Barletta, Barletta-Andria-Trani, Italië, 76121
        • Health and Social Care District No. 4 of Barletta, Azienda Sanitaria Locale BT
        • Contact:
          • Ilaria Alicino, MD
          • Telefoonnummer: 0883-577810
          • E-mail: dss4@aslbat.it

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
30-Day Home Stability
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Emergency Department Visits Within 30 Days
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Studie directeur: Domenico Spinazzola, Azienda Sanitaria Locale BT
  • Studie stoel: Ilaria Alicino, MD, Azienda Sanitaria Locale BT

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 januari 2027

Primaire voltooiing (Geschat)

1 juli 2027

Studie voltooiing (Geschat)

1 juli 2027

Studieregistratiedata

Eerst ingediend

10 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

10 september 2026

Eerst geplaatst (Werkelijk)

15 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 september 2026

Laatste update ingediend die voldeed aan QC-criteria

10 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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