NCT06878820

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

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
enrolling by invitation

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

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2025

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

November 22, 2024

Last Update Submit

March 17, 2025

Conditions

Keywords

function focused careimplementationleadershipmobilityADLnurses in the leadnursing care

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.

Behavioral: Function Focused Care

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.

Also known as: FFC, FFCiH, Function Focused Care in Hospital
Function Focused Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

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

Study Sites (3)

Stichting Slingeland Ziekenhuis

Doetinchem, 3584 CS, Netherlands

Location

Leiden University Medical Center

Leiden, Netherlands

Location

Erasmus MC

Rotterdam, Netherlands

Location

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: 39321557BACKGROUND
  • 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.

    PMID: 38746732BACKGROUND

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Interventions

Hospitals

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Health FacilitiesHealth Care Facilities Workforce and Services

Study Officials

  • Janneke M de Man - van Ginkel

    Leiden University Medical Center

    PRINCIPAL INVESTIGATOR

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

Locations