Clinical Governance of Home Care and 30-Day Stability

NCT07820852 | Not Yet Recruiting

• 1 other identifier: ASLBT-DSS4-ADI-2026
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From home care activation through 30 days

Secondary Outcomes (3)

• Emergency Department Visits Within 30 Days

  From home care activation through 30 days

• Unplanned Hospital Admissions Within 30 Days

  From home care activation through 30 days

• Time to Home Care Activation

  From home care request to home care activation, assessed up to 30 days

Study Arms (3)

Integrated Home Care (ADI)

Standard multidisciplinary integrated home care provided according to an individualized care plan.

Other: Integrated Home Care (ADI)

Scheduled GP Home Care (ADP)

Participants receiving scheduled home visits from their general practitioner.

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.

Other: Temporary Home Care (ADT)

Interventions

Integrated Home Care (ADI) OTHER

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

Integrated Home Care (ADI)

Scheduled GP Home Care (ADP) OTHER

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

Scheduled GP Home Care (ADP)

Temporary Home Care (ADT) OTHER

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

Temporary Home Care (ADT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Sanitaria Locale BT: lead

Study Sites (1)

Health and Social Care District No. 4 of Barletta, Azienda Sanitaria Locale BT

Barletta, Barletta-Andria-Trani, 76121, Italy

Location

MeSH Terms

Interventions

Adenosine Diphosphate; Androgen Antagonists

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Domenico Spinazzola

  Azienda Sanitaria Locale BT

  STUDY DIRECTOR

• Ilaria Alicino, MD

  Azienda Sanitaria Locale BT

  STUDY CHAIR

Central Study Contacts

Ilaria Alicino, MD

CONTACT

+39 0883 577810; dss4@aslbat.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 15, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 15, 2026

Record last verified: 2026-09

Locations

IT (1)