Home Care ServicesCG-HOME-DSS4NCT07820852
Clinical Governance of Home Care and 30-Day Stability
An observational study of Home Care Services and Quality of Health Care, run by Azienda Sanitaria Locale BT at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Home Care Services, Quality of Health Care
- What is being tested?
- Integrated Home Care (ADI), Scheduled GP Home Care (ADP) and Temporary Home Care (ADT)
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2027to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Health and Social Care District No. 4 of Barletta, Azienda Sanitaria Locale BT
Barletta, Barletta-Andria-Trani, 76121
Ilaria Alicino, MD, 0883-577810, dss4@aslbat.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Home Care Services, Quality of Health Care
- Being tested
- Integrated Home Care (ADI), Scheduled GP Home Care (ADP), Temporary Home Care (ADT)
- Keywords
- Clinical Governance, Integrated Home Care, Primary Care, Continuity of Care, Emergency Department Visits, Unplanned Hospital Admissions, 30-Day Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Home Care (ADI)Other
Standard scheduled home care provided by the participant's general practitioner.
Scheduled GP Home Care (ADP)Other
Standard scheduled home care provided by the participant's general practitioner.
Temporary Home Care (ADT)Other
Standard temporary home care provided to participants who are temporarily unable to attend an outpatient healthcare setting.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Home Care (ADI) | Standard multidisciplinary integrated home care provided according to an individualized care plan. Receives: Other: Integrated Home Care (ADI) | |
| Scheduled GP Home Care (ADP) | Participants receiving scheduled home visits from their general practitioner. Receives: Other: Scheduled GP Home Care (ADP) | |
| Temporary Home Care (ADT) | Participants receiving temporary home care because they are temporarily unable to attend an outpatient healthcare setting. Receives: Other: Temporary Home Care (ADT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-Day Home Stability
Percentage of participants with no emergency department visit and no unplanned hospital admission within 30 days after activation of home care.
Measured: From home care activation through 30 days
30-Day Home Stability
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.
Measured: From home care activation through 30 days
Secondary outcomes (3)
Emergency Department Visits Within 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.
Measured: From home care activation through 30 days
Unplanned Hospital Admissions Within 30 Days
Percentage of participants with at least one unplanned hospital admission within 30 days after activation of home care.
Measured: From home care activation through 30 days
Time to Home Care Activation
Number of days between the documented request for home care and the activation of the home care episode.
Measured: From home care request to home care activation, assessed up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study startJan 2027 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Home Care ServicesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale BT
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Domenico Spinazzola, Study director, Azienda Sanitaria Locale BTIlaria Alicino, MD, Study chair, Azienda Sanitaria Locale BT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820852
- Sponsor's protocol ID
- ASLBT-DSS4-ADI-2026
- Acronym
- CG-HOME-DSS4
- Status last verified
- Oct 2026
- First submitted
- 10 Sep 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07820852
- Acronym / sponsor ID
- CG-HOME-DSS4 / ASLBT-DSS4-ADI-2026
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Azienda Sanitaria Locale BTOther government
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Integrated Home Care (ADI) | – | Other: Integrated Home Care (ADI)Standard multidisciplinary integrated home care provided according to an individualized care plan. |
| Scheduled GP Home Care (ADP) | – | Other: Scheduled GP Home Care (ADP)Participants receiving scheduled home visits from their general practitioner. |
| Temporary Home Care (ADT) | – | Other: Temporary Home Care (ADT)Participants receiving temporary home care because they are temporarily unable to attend an outpatient healthcare setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Home Care (ADI)Standard scheduled home care provided by the participant's general practitioner. | Other | Integrated Home Care (ADI) |
| Scheduled GP Home Care (ADP)Standard scheduled home care provided by the participant's general practitioner. | Other | Scheduled GP Home Care (ADP) |
| Temporary Home Care (ADT)Standard temporary home care provided to participants who are temporarily unable to attend an outpatient healthcare setting. | Other | Temporary Home Care (ADT) |
Primary outcome
30-Day Home Stability
Time frame: 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.
30-Day Home Stability
Time frame: 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.
3 secondary outcomes
Emergency Department Visits Within 30 Days
Time frame: From home care activation through 30 days
Unplanned Hospital Admissions Within 30 Days
Time frame: From home care activation through 30 days
Time to Home Care Activation
Time frame: From home care request to home care activation, assessed up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Domenico Spinazzola study director
Azienda Sanitaria Locale BT
Ilaria Alicino, MD study chair
Azienda Sanitaria Locale BT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Home Care Services and Quality of Health Care, run by Azienda Sanitaria Locale BT at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ilaria Alicino, MD (+39 0883 577810, dss4@aslbat.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-Day Home Stability (time frame: From home care activation through 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.