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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ilaria Alicino, MD
- Phone Number: +39 0883 577810
- Email: dss4@aslbat.it
Study Locations
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Barletta-Andria-Trani
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Barletta, Barletta-Andria-Trani, Italy, 76121
- Health and Social Care District No. 4 of Barletta, Azienda Sanitaria Locale BT
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Contact:
- Ilaria Alicino, MD
- Phone Number: 0883-577810
- Email: dss4@aslbat.it
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Integrated Home Care (ADI)
Standard multidisciplinary integrated home care provided according to an individualized care plan.
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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.
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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.
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Standard temporary home care provided to participants who are temporarily unable to attend an outpatient healthcare setting.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
30-Day Home Stability
Time Frame: From home care activation through 30 days
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Percentage of participants with no emergency department visit and no unplanned hospital admission within 30 days after activation of home care.
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From home care activation through 30 days
|
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30-Day Home Stability
Time Frame: From home care activation through 30 days
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emergency Department Visits Within 30 Days
Time Frame: 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.
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From home care activation through 30 days
|
|
Unplanned Hospital Admissions Within 30 Days
Time Frame: From home care activation through 30 days
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Percentage of participants with at least one unplanned hospital admission within 30 days after activation of home care.
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From home care activation through 30 days
|
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Time to Home Care Activation
Time Frame: From home care request to home care activation, assessed up to 30 days
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Number of days between the documented request for home care and the activation of the home care episode.
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From home care request to home care activation, assessed up to 30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Domenico Spinazzola, Azienda Sanitaria Locale BT
- Study Chair: Ilaria Alicino, MD, Azienda Sanitaria Locale BT
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Nucleic Acids, Nucleotides, and Nucleosides
- Pharmacologic Actions
- Chemical Actions and Uses
- Purines
- Ribonucleotides
- Nucleotides
- Adenine Nucleotides
- Purine Nucleotides
- Androgen Antagonists
- Adenosine Diphosphate
Other Study ID Numbers
- ASLBT-DSS4-ADI-2026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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