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Clinical Governance of Home Care and 30-Day Stability (CG-HOME-DSS4)

2026年9月10日 更新者:Azienda Sanitaria Locale BT

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.

調査の概要

詳細な説明

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.

研究の種類

観察的

入学 (推定)

500

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Ilaria Alicino, MD
  • 電話番号:+39 0883 577810
  • メール:dss4@aslbat.it

研究場所

    • Barletta-Andria-Trani
      • Barletta、Barletta-Andria-Trani、イタリア、76121
        • Health and Social Care District No. 4 of Barletta, Azienda Sanitaria Locale BT
        • コンタクト:
          • Ilaria Alicino, MD
          • 電話番号:0883-577810
          • メール:dss4@aslbat.it

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
Integrated Home Care (ADI)
Standard multidisciplinary integrated home care provided according to an individualized care plan.
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.
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.
Standard temporary home care provided to participants who are temporarily unable to attend an outpatient healthcare setting.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
30-Day Home Stability
時間枠: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.
From home care activation through 30 days
30-Day Home Stability
時間枠: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.
From home care activation through 30 days

二次結果の測定

結果測定
メジャーの説明
時間枠
Emergency Department Visits Within 30 Days
時間枠: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.
From home care activation through 30 days
Unplanned Hospital Admissions Within 30 Days
時間枠: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.
From home care activation through 30 days
Time to Home Care Activation
時間枠: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.
From home care request to home care activation, assessed up to 30 days

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • スタディディレクター:Domenico Spinazzola、Azienda Sanitaria Locale BT
  • スタディチェア:Ilaria Alicino, MD、Azienda Sanitaria Locale BT

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2027年1月1日

一次修了 (推定)

2027年7月1日

研究の完了 (推定)

2027年7月1日

試験登録日

最初に提出

2026年9月10日

QC基準を満たした最初の提出物

2026年9月10日

最初の投稿 (実際)

2026年9月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月15日

QC基準を満たした最後の更新が送信されました

2026年9月10日

最終確認日

2026年9月1日

詳しくは

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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