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

10. september 2026 opdateret af: 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.

Studieoversigt

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

500

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. januar 2027

Primær færdiggørelse (Anslået)

1. juli 2027

Studieafslutning (Anslået)

1. juli 2027

Datoer for studieregistrering

Først indsendt

10. september 2026

Først indsendt, der opfyldte QC-kriterier

10. september 2026

Først opslået (Faktiske)

15. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. september 2026

Sidst verificeret

1. september 2026

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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