Clinical trial NCT06878820: Nurses in the Lead - Nursing Leadership and Autonomy in Function Focused Care in Hospital
Official title: Nurses in the Lead - Nursing Leadership and Autonomy in Function Focused Care in Hospital: a Prospective Before-after Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Nurse-Patient Relations
Implementation Research
Physical Inactivity
Physical Activities
ADL
Mobility and Independence
Leadership
Interprofessional Team Collaboration
Hospital Care
Keywords: function focused care
implementation
leadership
mobility
ADL
nurses in the lead
nursing care
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
name: Slingeland Hospital
First posted: 2025-03-17
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed description: The investigators will conduct a prospective before-after multicenter study, including a process evaluation, with a mixed methods approach in two university medical centers. In the preparation phase before the before-after study the tailored implementation strategy for FFCiH will be developed. Between the before and after phases of the study, the investigators will implement in two or three cyclic processes the FFCiH approach by strengthening nursing leadership and autonomy in the application of FFCiH in the interprofessional collaboration, using the predefined tailored implementation strategy.

Eligibility criteria: Nurses and student nurses (vocational nursing educational level (MBO)/ (bachelor nursing educational level (HBO)):

Inclusion Criteria:

- 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.

Exclusion Criteria:

- No exclusion criteria were defined for nurses and student nurses.

Physiotherapists, doctors and other member of the interprofessional team;

Inclusion Criteria:

- 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.

Exclusion Criteria:

- No exclusion criteria were defined for physiotherapists, doctors and other members of the interprofessional team.

Patients and informal caregivers:

Inclusion Criteria:

- 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Level of leadership using the Leadership Practices Inventory (LPI) - Nurses
timeFrame: up to four weeks directly before implementation & up to four weeks directly after implementation
measure: Level of autonomy - Nurses
timeFrame: up to four weeks directly before implementation & up to four weeks directly after implementation
Secondary outcomes:
measure: Adherence (fidelity)
timeFrame: up to four weeks after implementation
measure: Level of mobility - Patients
timeFrame: <72 hours after hospital admission and at discharge (assessed up to 3 days)
measure: Level of independence in Activities of Daily Livings - patients
timeFrame: <72 hours after hospital admission and at discharge (assessed up to 3 days)
measure: Level of coverage (reach)
timeFrame: up to four weeks after implementation
measure: Numbers of days stayed in the hospital - patients
timeFrame: At discharge (assessed up to 14 days)
Other outcomes:
measure: Baseline characteristics nurses
timeFrame: Up to four weeks before implementation
measure: Baseline characteristics patients and their informal caregivers
timeFrame: <72 hours after hospital admission
Locations:
city: Doetinchem
country: Netherlands
facility: Stichting Slingeland Ziekenhuis
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
affiliation: Leiden University Medical Center
name: Janneke M de Man - van Ginkel
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Kok 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.