- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus 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.
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Ilaria Alicino, MD
- Puhelinnumero: +39 0883 577810
- Sähköposti: dss4@aslbat.it
Opiskelupaikat
-
-
Barletta-Andria-Trani
-
Barletta, Barletta-Andria-Trani, Italia, 76121
- Health and Social Care District No. 4 of Barletta, Azienda Sanitaria Locale BT
-
Ottaa yhteyttä:
- Ilaria Alicino, MD
- Puhelinnumero: 0883-577810
- Sähköposti: dss4@aslbat.it
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
|
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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
30-Day Home Stability
Aikaikkuna: 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
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Emergency Department Visits Within 30 Days
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: Domenico Spinazzola, Azienda Sanitaria Locale BT
- Opintojen puheenjohtaja: Ilaria Alicino, MD, Azienda Sanitaria Locale BT
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Huumeiden fysiologiset vaikutukset
- Hormonit, hormonikorvikkeet ja hormoniantagonistit
- Hormoniantagonistit
- Heterosykliset yhdisteet
- Heterosykliset yhdisteet, 2-rengas
- Heterosykliset yhdisteet, sulatettu rengas
- Nukleiinihapot, nukleotidit ja nukleosidit
- Farmakologiset vaikutukset
- Kemialliset vaikutukset ja käyttötarkoitukset
- Puriinit
- Ribonukleotidit
- Nukleotidit
- Adeniininukleotidit
- Puriini -nukleotidit
- Androgeeniantagonistit
- Adenosiinidifosfaatti
Muut tutkimustunnusnumerot
- ASLBT-DSS4-ADI-2026
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .