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Effectiveness of a Nurse-Led Transitional Care Model Based on the Fundamentals of Care Framework (NURSE-LEDFOC)

2 november 2026 bijgewerkt door: Jacopo Fiorini, University of Rome Tor Vergata

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

652

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Italië
      • Rome, Italië, 00133
        • Nursing Department

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: Community Hospital

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.
Actieve vergelijker: 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.
Ander: Usual Care

Participants received standard hospital care and returned directly home after discharge, without the additional nurse-led transitional care program.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Unplanned Hospital Readmission Within 30 Days
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Functional Independence Assessed by the Barthel Index
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Rome Tor Vergata

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 september 2025

Primaire voltooiing (Werkelijk)

30 april 2026

Studie voltooiing (Werkelijk)

30 april 2026

Studieregistratiedata

Eerst ingediend

28 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 november 2026

Eerst geplaatst (Werkelijk)

6 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 669
  • 2.26.3 (Ander subsidie-/financieringsnummer: Center of Excellence for Culture and Research Nursing of the Professions Order Nursing of Rome)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

Beginning 6 months after publication of the study results and ending 5 years after publication

IPD-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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