Nurses in the Lead - Nursing Leadership and Autonomy in Function Focused Care in Hospital
2 other identifiers
observational
180
1 country
3
Brief Summary
The goal of this prospective before-after study (observational) is to implement Function Focused Care in Hospital (FFCiH), paying specific attention to the role of nurses and how they can take the leadership and autonomy in the interprofessional collaboration regarding FFCiH. To reach this aim, the researchers defined two sub-objectives: 1\. to identify barriers and facilitators (determinants) for nursing autonomy and leadership and application FFCiH in the interprofessional collaboration on a surgical and internal medicine ward to design a tailored implementation strategy for FFCiH. 2. to evaluate the effectiveness of the implementation strategy on nursing leadership and the application of FFCiH. The investigators developed two work packages related to the two sub-objectives: identifying determinants and strategies for the successful application of FFCiH and nurse leadership, among others, by introducing nurse champions and evaluating their effect on the application of FFCiH. The primary endpoint is the level of application of FFCiH as reflected in adherence to and coverage of FFCiH in daily nursing care. The secondary endpoints are: 1) for nurses: the nurses' role development with regards to leadership and autonomy in the application of FFCiH by ward nurses and nurse champions, leadership competencies of ward nurses, and autonomy of ward nurses and 2) for patients: physical functioning and independency in mobility and ADL. Researchers will compare FFCiH with usual care to see if there are differences regarding the outcome measurements. The study population consists of nurses, physiotherapists, doctors, other member of the interprofessional team, hospitalized patients and their relatives. Intervention: FFCiH focuses on stimulating nurses to promote patients' self-reliance in daily functioning, encouraging the patients' engagement in daily activities and, helping patients to attain and maintain their highest level of function and increasing time spent in physical activity. FFCiH is a proven effective approach for promoting patients' physical functioning and mobility.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2024
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 18, 2024
CompletedFirst Submitted
Initial submission to the registry
November 22, 2024
CompletedFirst Posted
Study publicly available on registry
March 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 5, 2025
CompletedMarch 18, 2025
March 1, 2025
6 months
November 22, 2024
March 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Level of leadership using the Leadership Practices Inventory (LPI) - Nurses
The LPI questionnaire consist of 30 leadership behaviors presented as behavioral statements, that can categorized into 5 subscales, representing five leadership practices: 1) Model the way, 2) Inspire a shared vision, 3) Challenge the process, 4) Enable others to act, and 5) Encourage the heart. Each of these statement can be scored on a 10-point Likert scale, for which a higher score indicate more frequent the respondent engage in the leadership behavior. The internal reliability of the LPI in nurses ranges from 0.66 to 0.96.36 The original questionnaire has been translated into Dutch.
up to four weeks directly before implementation & up to four weeks directly after implementation
Level of autonomy - Nurses
Using the Maastricht Autonomy Questionnaire (MAQ), which consists of 10 items scored on a five-point Likert scale ranging from very little to very much.The total score ranges from 10 to 50. Higher scores indicate more job autonomy. The questionnaire includes information on job control and freedom in work tasks and methods. It measures the opportunity for staff to determine a variety of task elements, such as the pace of work and the work goals. A sample item is: 'My work offers me the opportunity to interrupt my job whenever I want.' Current study findings confirmed good internal consistency (Cronbach's alpha=0.90).
up to four weeks directly before implementation & up to four weeks directly after implementation
Secondary Outcomes (5)
Adherence (fidelity)
up to four weeks after implementation
Level of mobility - Patients
<72 hours after hospital admission and at discharge (assessed up to 3 days)
Level of independence in Activities of Daily Livings - patients
<72 hours after hospital admission and at discharge (assessed up to 3 days)
Level of coverage (reach)
up to four weeks after implementation
Numbers of days stayed in the hospital - patients
At discharge (assessed up to 14 days)
Other Outcomes (2)
Baseline characteristics nurses
Up to four weeks before implementation
Baseline characteristics patients and their informal caregivers
<72 hours after hospital admission
Study Arms (2)
Function Focused Care
Nurses provide care according to Function Focused Care in Hospital (FFCiH) principles. After implementation of this intervention, all patients admitted to the selected wards in the hospital receive FFCiH.
Usual Care
Before implementation of Function Focused Care in Hospital, nurses provide care as usual to patients admitted to the selected wards in hospital
Interventions
FFCiH is an effective nursing approach and focuses on stimulating nurses to promote patients' self-reliance in daily functioning, encouraging the patients' engagement in daily activities and helping patients to attain and maintain their highest level of function and to increase time spent in physical activity.
Eligibility Criteria
The domain of this study consists of * nurses, physiotherapists, doctors, other member of the interprofessional team (e.g. occupational therapist), * patients admitted to a surgical respectively internal medicine ward of a hospital, and their informal caregivers.
You may qualify if:
- \- All (student-)nurses working in the participating wards are expected to be involved in application of FFC and role development with regards to leadership and autonomy of nurses and therefore considered to be eligible for participation in the study.
You may not qualify if:
- Physiotherapists, doctors and other member of the interprofessional team;
- \- All professional groups that are part of the interprofessional team of the ward and who work in the participating wards are expected to collaborate with the nursing in their daily care and therefore considered to be eligible for participation in this study.
- Patients and informal caregivers:
- \- All patients admitted to the participating wards of the 2 hospitals receiving care either before or after the implementation of FFC and the patients informal caregiver as determined by the patient.
- A life-threatening situation or in a terminal phase upon admission (only applicable to patients)
- Not mastering the Dutch language;
- Not able to communicate adequately, based on a below threshold score on the MOCA or the FAST (only applicable to patients)
- A second hospitalization on one of the participating wards after being included in the study during the study period;
- An hospitalization \< 48 hours
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Leiden University Medical Centerlead
- Erasmus Medical Centercollaborator
- Slingeland Hospitalcollaborator
Study Sites (3)
Stichting Slingeland Ziekenhuis
Doetinchem, 3584 CS, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Erasmus MC
Rotterdam, Netherlands
Related Publications (2)
Kok S, Schoonhoven L, Vernooij LM, Reitsma JB, Verstraten C, Metzelthin SF, Bleijenberg N, de Man-van Ginkel JM. The effectiveness of Function Focused Care among patients acutely admitted to hospital: A stepped wedge cluster trial. Int J Nurs Stud. 2024 Dec;160:104893. doi: 10.1016/j.ijnurstu.2024.104893. Epub 2024 Sep 4.
PMID: 39321557BACKGROUNDKok S, de Man-van Ginkel JM, Verstraten C, Resnick B, Metzelthin SF, Bleijenberg N, Schoonhoven L. Function focused care in hospital: A mixed-method feasibility study. Int J Nurs Stud Adv. 2021 Sep 29;3:100045. doi: 10.1016/j.ijnsa.2021.100045. eCollection 2021 Nov.
PMID: 38746732BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Janneke M de Man - van Ginkel
Leiden University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
November 22, 2024
First Posted
March 17, 2025
Study Start
November 18, 2024
Primary Completion
May 5, 2025
Study Completion
June 5, 2025
Last Updated
March 18, 2025
Record last verified: 2025-03