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NCT Number: NCT07820852

Clinical Governance of Home Care and 30-Day Stability

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Barletta, Barletta-Andria-Trani, 76121, Italy

Location contact

Ilaria Alicino, MD

CONTACT

[email protected]

0883-577810

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. Unplanned Hospital Admissions Within 30 Days

    Time frame: 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.

  3. Time to Home Care Activation

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ilaria Alicino, MD

CONTACT

[email protected]

+39 0883 577810

Sponsors and collaborators

Lead sponsor

Azienda Sanitaria Locale BT

Other Gov

Registry information

Official study 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

Acronym: CG-HOME-DSS4

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Sep 15, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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