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Clinical Governance of Home Care and 30-Day Stability

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07820852
Acronym
CG-HOME-DSS4
Enrollment
500
Registered
2026-09-15
Start date
2027-01-01
Completion date
2027-07-01
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Home Care Services, Quality of Health Care

Keywords

Clinical Governance, Integrated Home Care, Primary Care, Continuity of Care, Emergency Department Visits, Unplanned Hospital Admissions, 30-Day Outcomes

Brief summary

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.

Detailed description

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.

Interventions

OTHERIntegrated Home Care (ADI)

Standard scheduled home care provided by the participant's general practitioner.

OTHERScheduled GP Home Care (ADP)

Standard scheduled home care provided by the participant's general practitioner.

OTHERTemporary Home Care (ADT)

Standard temporary home care provided to participants who are temporarily unable to attend an outpatient healthcare setting.

Sponsors

Azienda Sanitaria Locale BT
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
30-Day Home StabilityFrom home care activation through 30 daysPercentage of participants with no emergency department visit and no unplanned hospital admission within 30 days after activation of home care.

Secondary

MeasureTime frameDescription
Emergency Department Visits Within 30 DaysFrom home care activation through 30 daysPercentage of participants with at.gmail least one emergency department visit, without subsequent hospital admission, within 30 days after activation of home care.
Unplanned Hospital Admissions Within 30 DaysFrom home care activation through 30 daysPercentage of participants with at least one unplanned hospital admission within 30 days after activation of home care.
Time to Home Care ActivationFrom home care request to home care activation, assessed up to 30 daysNumber of days between the documented request for home care and the activation of the home care episode.

Countries

Italy

Contacts

CONTACTIlaria Alicino, MD
dss4@aslbat.it+39 0883 577810
STUDY_DIRECTORDomenico Spinazzola

Azienda Sanitaria Locale BT

STUDY_CHAIRIlaria Alicino, MD

Azienda Sanitaria Locale BT

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026