Clinical Governance of Home Care and 30-Day Stability
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Sanitaria Locale BT
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Integrated Home Care (ADI)
Other interventionStandard scheduled home care provided by the participant's general practitioner.
Scheduled GP Home Care (ADP)
Other interventionStandard scheduled home care provided by the participant's general practitioner.
Temporary Home Care (ADT)
Other interventionStandard temporary home care provided to participants who are temporarily unable to attend an outpatient healthcare setting.
Treatment groups
500 Participants
are divided into 3 treatment groupsGroup A: Integrated Home Care (ADI)1 intervention
Group B: Scheduled GP Home Care (ADP)1 intervention
Group C: Temporary Home Care (ADT)1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From home care activation through 30 days2
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.
Time frame
From home care activation through 30 daysSecondary outcomes
1
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.
Time frame
From home care activation through 30 days2
Unplanned Hospital Admissions Within 30 Days
Percentage of participants with at least one unplanned hospital admission within 30 days after activation of home care.
Time frame
From home care activation through 30 days3
Time to Home Care Activation
Number of days between the documented request for home care and the activation of the home care episode.
Time frame
From home care request to home care activation, assessed up to 30 daysSponsors and contacts
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Source ClinicalTrials.gov
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