Effectiveness of a Nurse-Led Transitional Care Model Based on the Fundamentals of Care Framework (NURSE-LEDFOC)
This study aims to find out whether nurse-led transitional care can help older adults with chronic health conditions recover safely after leaving the hospital. It also examines whether this approach can lower the risk of returning to the hospital within 30 days.
The study includes 652 adults aged 60 years or older with at least one long-term health condition. All participants were receiving care in medical wards at an Italian university hospital and were preparing to return home.
Participants were randomly assigned to one of two groups:
Nurse-led transitional care: Participants received additional care in a nurse-led unit before returning home. Nurses assessed their health and daily needs, provided personalized care and education, and helped plan a safe return home. This approach followed the Fundamentals of Care Framework, which focuses on meeting people's physical, emotional, and social care needs.
Usual care: Participants received standard hospital care and returned directly home after discharge, without the additional nurse-led transitional care program.
Researchers assessed participants' ability to perform daily activities, memory and thinking skills, risk of falls, and risk of developing pressure injuries (skin damage caused by prolonged pressure). They also checked whether participants returned to the hospital unexpectedly within 30 days.
By comparing the two groups, the study aims to understand whether additional nurse-led care can support recovery, improve independence, and help older adults remain safely at home after hospitalization.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Rome、イタリア、00133
- Nursing Department
-
-
参加基準
適格基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Adults aged 60 years or older.
- Diagnosis of at least one chronic condition (e.g., chronic obstructive pulmonary disease, diabetes, heart disease, heart failure, musculoskeletal disorders, or hypertension).
- Ability to understand the study information and provide informed consent.
- Planned discharge from an acute medical ward to their own home.
Exclusion Criteria:
- Participants requiring daily assistance from a family member or informal caregiver to perform activities of daily living.
- Inability to understand the study information or provide informed consent.
- Planned discharge to other healthcare or residential care settings, such as nursing homes or rehabilitation centers.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:ヘルスサービス研究
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的:Community Hospital
Participants assigned to this group received nurse-led transitional care in a Community Hospital before returning home. The intervention was based on the Fundamentals of Care Framework and included comprehensive nursing assessment, individualized care planning, daily clinical monitoring, patient education, and coordinated discharge planning. Nurses supported participants' physical, emotional, and social care needs, promoted self-care skills, and coordinated care with community health services. The maximum length of stay was 14 days, followed by a 30-day follow-up after discharge. |
The intervention was based on the Fundamentals of Care Framework and included comprehensive nursing assessment, individualized care planning, daily clinical monitoring, patient education, and coordinated discharge planning. Nurses supported participants' physical, emotional, and social care needs, promoted self-care skills, and coordinated care with community health services. The maximum length of stay was 14 days, followed by a 30-day follow-up after discharge. |
|
アクティブコンパレータ:Usual Care - Direct Discharge Home
Participants assigned to this group received usual care in acute medical wards and were discharged directly home after clinical stabilization. They received standard discharge instructions and routine care, without transfer to a Community Hospital or participation in the structured nurse-led transitional care program. Community health services were provided when indicated according to usual clinical practice. Participants were followed up 30 days after discharge. |
Participants received standard hospital care and returned directly home after discharge, without the additional nurse-led transitional care program. |
この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Unplanned Hospital Readmission Within 30 Days
時間枠:Within 30 days after final hospital discharge
|
The proportion of participants experiencing at least one unplanned hospital readmission within 30 days after final hospital discharge. Readmissions to any hospital in the Lazio region were identified using regional administrative hospital databases. The outcome was compared between the nurse-led transitional care group and the usual care group. |
Within 30 days after final hospital discharge
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Functional Independence Assessed by the Barthel Index
時間枠:Baseline and 30 days after final hospital discharge.
|
Functional independence was assessed using the Barthel Index, which measures the ability to perform 10 basic activities of daily living, including feeding, bathing, dressing, mobility, and personal hygiene. Total scores range from 0 to 100, with higher scores indicating greater independence. Changes from baseline were compared between the two study groups. |
Baseline and 30 days after final hospital discharge.
|
|
Change in Pressure Injury Risk Assessed by the Braden Scale
時間枠:Baseline and 30 days after final hospital discharge.
|
The risk of developing pressure injuries was assessed using the Braden Scale, which evaluates six areas: sensory perception, skin moisture, physical activity, mobility, nutrition, and friction or shear. Total scores range from 6 to 23, with lower scores indicating a higher risk of pressure injuries. Changes from baseline were compared between the two study groups. |
Baseline and 30 days after final hospital discharge.
|
|
Change in Cognitive Status Assessed by the Short Portable Mental Status Questionnaire
時間枠:Baseline and 30 days after final hospital discharge.
|
Cognitive status was assessed using the Short Portable Mental Status Questionnaire (SPMSQ), a 10-item instrument evaluating orientation, memory, and basic cognitive functioning. According to the scoring system used in this study, total scores range from 0 to 11, with higher scores indicating better cognitive functioning. Changes from baseline were compared between the two study groups. |
Baseline and 30 days after final hospital discharge.
|
|
Change in Fall Risk Assessed by the Modified Morse Fall Scale
時間枠:Baseline and 30 days after final hospital discharge.
|
Fall risk was assessed using a modified version of the Morse Fall Scale consisting of six dichotomous items. Total scores range from 0 to 6, with higher scores indicating greater fall risk. Scores of 0-2 indicate low risk, 3-4 moderate risk, and 5-6 high risk. Changes from baseline were compared between the two study groups. |
Baseline and 30 days after final hospital discharge.
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Saari H, Lonnroos E, Kautiainen H, Kokko S, Ryynanen OP, Mantyselka P. Incidence of short-term community hospital stays and clinical profiles of patients: the Finnish Community Hospital Cohort Study. Scand J Prim Health Care. 2024 Mar;42(1):82-90. doi: 10.1080/02813432.2023.2291671. Epub 2024 Feb 7.
- Sun M, Qian Y, Liu L, Wang J, Zhuansun M, Xu T, Rosa RD. Transition of care from hospital to home for older people with chronic diseases: a qualitative study of older patients' and health care providers' perspectives. Front Public Health. 2023 Apr 27;11:1128885. doi: 10.3389/fpubh.2023.1128885. eCollection 2023.
- Recio-Saucedo A, Dall'Ora C, Maruotti A, Ball J, Briggs J, Meredith P, Redfern OC, Kovacs C, Prytherch D, Smith GB, Griffiths P. What impact does nursing care left undone have on patient outcomes? Review of the literature. J Clin Nurs. 2018 Jun;27(11-12):2248-2259. doi: 10.1111/jocn.14058. Epub 2017 Oct 16.
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- 669
- 2.26.3 (その他の助成金/資金番号:Center of Excellence for Culture and Research Nursing of the Professions Order Nursing of Rome)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
De-identified individual participant data underlying the results reported in this study may be made available to qualified researchers upon reasonable request to the corresponding author. Data sharing will be subject to approval of the research team and compliance with applicable ethical and data protection requirements. No directly identifiable participant information will be shared.
IPD 共有時間枠
Beginning 6 months after publication of the study results and ending 5 years after publication
IPD 共有アクセス基準
De-identified individual participant data and supporting study documents may be made available to qualified researchers who submit a reasonable request to the corresponding author. Requests must include a research proposal describing the scientific objectives, planned analyses, and intended use of the data. Access will be subject to approval by the research team and compliance with applicable ethical and data protection requirements. Approved researchers will receive access to the data necessary for their proposed analyses through a secure data-sharing process. Data will not be made publicly available.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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