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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Rome, Italy, 00133
- Nursing Department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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. |
|
Active Comparator: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Unplanned Hospital Readmission Within 30 Days
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Functional Independence Assessed by the Barthel Index
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 669
- 2.26.3 (Other Grant/Funding Number: Center of Excellence for Culture and Research Nursing of the Professions Order Nursing of Rome)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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 Sharing Time Frame
Beginning 6 months after publication of the study results and ending 5 years after publication
IPD Sharing Access Criteria
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 Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.