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NCT Number: NCT06878820

Nurses in the Lead - Nursing Leadership and Autonomy in Function Focused Care in Hospital

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stichting Slingeland Ziekenhuis, Doetinchem, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Function Focused Care

Behavioral

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.

Other names: FFC, FFCiH, Function Focused Care in Hospital

Primary outcomes

  1. Level of leadership using the Leadership Practices Inventory (LPI) - Nurses

    Time frame: up to four weeks directly before implementation & up to four weeks directly after implementation

    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.

  2. Level of autonomy - Nurses

    Time frame: up to four weeks directly before implementation & up to four weeks directly after implementation

    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).

Secondary outcomes

  1. Adherence (fidelity)

    Time frame: up to four weeks after implementation

    Refers to the extent to which FFCiH has been applied as intended, and will be measured with the key components of FFCiH, such as goal setting with patient, individualized care plan, encouragement of patient's active involvement in ADL and evaluation the level of the patient's ADL-independence and mobility.

    This outcome will be measured with

    • qualitative focus group interviews with the multidisciplinary team and individual interviews with patients. Topics include the key components of FFCiH.
    • Screening of electronic patient records. The electronic patient records will be screened on the number of reported short- and long-term goals and the amount of nursing report that contains information about bathing, dressing, mobility or transfers.
  2. Level of mobility - Patients

    Time frame: <72 hours after hospital admission and at discharge (assessed up to 3 days)

    Measured using the AMEXO. this measure is the Amsterdam UMC extension of the John Hopkins Highest Level of Mobility (AMEXO) scale. The instrument consist of twelve categories representing the highest level of mobility. The response categories includes: 1= bed lying; 2= bed turn self/activity; 3= bed sit at edge; 4= chair transfer; 5= stand 1 minute; 6=walk 10+ steps; 7=walk 25+ feet; 8=walk 250+ feet ,9= 225m; 10= 450m; 11= 750m; 12= 1125m.:.'. The higher the total score, the higher the level of independence.

  3. Level of independence in Activities of Daily Livings - patients

    Time frame: <72 hours after hospital admission and at discharge (assessed up to 3 days)

    Measured with the KATZ-ADL. This measurement consists of 6 items: bathing, dressing, toilet visit, movement inside the house, continence, feeding. The items score on a 2 point scale: dependent or independent.

  4. Level of coverage (reach)

    Time frame: up to four weeks after implementation

    Refers to the extent to which patients actually receive FFCiH, and measured by determining the extent to which patients who qualify for FFCiH actually receive it.

    This outcome will be measured with 1) qualitative focus group interviews with the multidisciplinary team and individual interviews with patients. Topics include the key components of FFCiH. 2) Screening of electronic patient records. The electronic patient records will be screened on the number of reported short- and long-term goals and the amount of nursing report that contains information about bathing, dressing, mobility or transfers.

  5. Numbers of days stayed in the hospital - patients

    Time frame: At discharge (assessed up to 14 days)

    Based on the findings in our previous study and known from clinical practice, we know that discharge from hospital highly depends on independence in ADL and/or mobility. As a result, it is expected that a recovery of independence in ADL and mobility primarily does not lead to higher levels of independence in ADL and mobility at discharge, but to a shorter admission with the same level of independence in ADL and mobility. Therefore, we also will collect data from patient files regarding the duration of hospital admission.

Other outcomes

  1. Baseline characteristics nurses

    Time frame: Up to four weeks before implementation

    • age (years)
    • Gender (male, female, other)
    • type of ward of (primarily) employment (surgical, internal medicine, orthopedic surgical, pulmonary, etc.)
    • level of education level (MBO, HBO, Master, PhD)
    • years of experience as health care professional (years)
    • team longevity (years of membership of the team)
  2. Baseline characteristics patients and their informal caregivers

    Time frame: <72 hours after hospital admission

    • Age (years)
    • Gender (male, female, other)
    • educational level (numbers of years of education / last occupation)
    • marital status (single, married/cohabiting, widowed/divorced)
    • living accommodation (independent alone, independent with informal caregiver, independent with others, nursing home)
    • (number of) somatic diagnoses, admission diagnose, (patient)
    • use of walking aid/device (yes/no) (patient)
    • relationship to patient (spouse/partner, child, parent, neighbour, friend) (informal caregiver)

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • Erasmus Medical Center
  • Slingeland Hospital

Registry information

Official study title

Nurses in the Lead - Nursing Leadership and Autonomy in Function Focused Care in Hospital: a Prospective Before-after Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 17, 2025
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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