Effects on Nurses' Quality of Working Life of an Educational Intervention to Strengthen Their Humanistic Practice (ExpCare)

February 2, 2021 updated by: Philippe Delmas, Institut et Haute Ecole de la Santé la Source

Effects on Nurses' Quality of Working Life and on Patients' Quality of Life of an Educational Intervention to Strengthen Humanistic Practice Among Haemodialysis Nurses in Switzerland: A Mixed Methods Cluster Randomised Controlled Trial

Haemodialysis (HD) patients constitute a vulnerable population with considerable health needs. They are often older persons with comorbid chronic conditions. Despite the substantial technical care they receive, these patients indicate that the quality of the human relationship that develops with nurses-the pivotal element in the care this population receives-can become therapeutic. This feature of the human relationship constitutes the cornerstone of the humanistic practice (caring practice) that all nurses should adhere to. However, according to some authors, such practice tends to fade over time. In 2012, a pilot study allowed to test an educational intervention based on Watson's Theory of Human Caring, the aim of which was to optimise nurses' humanistic practices. The intervention, first developed in Quebec and adapted in Switzerland by a committee of experts, was delivered to a group of nine HD nurses (Canton of Vaud, Switzerland) and evaluated. Preliminary results (qualitative and quantitative) showed the intervention to be highly feasible and acceptable. Moreover, in terms of preliminary outcomes, participating nurses appeared to strengthen their caring attitudes/behaviours toward HD patients post-intervention. Quantitative analyses of patients' questionnaires showed that HD patients perceived significant changes in nurses' caring attitudes/behaviours and maintained their level of quality of life (QoL) over time, which is a definite gain for this population. In light of these positive results, it is important to pursue this line of investigation in order to examine more accurately the intervention's effects on both nurses and patients. To this end, the investigators propose conducting a mixed-methods cluster randomised controlled trial (RCT) to assess the effects of an educational intervention to strengthen humanistic practice among nurses working in HD units in French Switzerland, on perceived quality of the nurse-patient relationship (NPR), nurses' team cohesion, nurses' quality of working life (QoWL), and HD patients' QoL. Knowledge acquired in the course of the study will contribute to strengthen nurses' humanistic practice, a key factor in HD patients' QoL.

Study Overview

Study Type

Interventional

Enrollment (Actual)

241

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Genève, Switzerland
        • Hôpitaux Universitaires de Genève (HUG)
    • Jura
      • Delémont, Jura, Switzerland
        • Hopital du Jura
    • Vallais
      • Martigny, Vallais, Switzerland
        • Hôpital du Valais - Martigny
      • Monthey, Vallais, Switzerland
        • Hôpital Riviera-Chablais (HRC)
      • Sierre, Vallais, Switzerland
        • Hôpital du Valais - Sierre
      • Sion, Vallais, Switzerland
        • Hôpital du Valais - Sion
    • Vaud
      • Lausanne, Vaud, Switzerland
        • Centre Hospitalier Universitaire Vaudois (CHUV)
      • Morges, Vaud, Switzerland
        • Hôpital de Morges - Ensemble Hospitalier de la Côte
      • Payerne, Vaud, Switzerland
        • Hôpital Intercantonal de la Broye (HIB)
      • Yverdon-les-Bains, Vaud, Switzerland
        • Etablissements hospitaliers du Nord Vaudois (eHnv)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Nurses:

    1. have at least 6 months' work experience in the department;
    2. consent to take part in the study. In addition, nurses who intend to leave the HD unit in the 3 months to come will be excluded
  • Patients

    1. be at least 18 years of age and under active treatment for at least 6 months;
    2. understand and read French;
    3. able to provide informed consent.

Exclusion Criteria:

  • Nurses:

    1. intention to leave the HD unit in the 3 months after the beginning of the project

  • Patients

    1. being diagnosed with dementia
    2. being a new HD patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: educational intervention
Various pedagogical activities to mobilise Watson's ten Carative Factors

Four educational sessions:

  • Acquisition of core concepts of caring practice (I)
  • Acquisition of core concepts of caring practice (II)
  • Search for meaning: Influencing hope in persons through humanistic practice
  • Enacting different caring attitudes and behaviours in an intermediary simulation exercise with actor
No Intervention: control
No intervention during the different times of measurement. Educational intervention will be delivered after the last measure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nurse-patient relationship (NPR)
Time Frame: 30 months
NPR will be measured with the French version (EIIP-70) of the Caring Nurse-Patient Interaction Scale (CNPI-70). This tool comprises 70 items across 10 dimensions that capture each of Watson's 10 CF. It allows nurses to selfevaluate their frequency of caring attitudes/behaviours. More specifically, the EIIP-70 covers the following dimensions: humanism (6 items), hope (7 items), sensitivity (6 items), relationship (7 items), emotions (6 items), problem solving (6 items), teaching (11 items), assistance (10 items) and existential factors (6 items). Respondents must choose from five responses ranging from 1 (almost never) to 5 (almost always). This tool was validated on 377 nursing students and demonstrates good psychometric properties (Cronbach's alphas for the ten sub-dimensions range from .73 to .91).
30 months
Nurses' team cohesion
Time Frame: 30 months
Team cohesion will be measured with the Group Environment Questionnaire (GEQ), which was subsequently adapted for work teams. Like the original, the French version contains 18 items and encompasses the four dimensions of team cohesion, namely, respondent's social-related attraction to the group (5 items, 1 of which is reverse scored), respondent's task-related attraction to the group (4 items, 2 of which are reverse scored), social-related group integration as perceived by respondent (4 items, 2 of which are reverse scored), and task-related group integration as perceived by respondent (5 items, 1 of which is reverse scored). The response scale ranges from 1 (strongly disagree) to 5 (strongly agree). The questionnaire was tested on a sample of nurses from another healthcare institution. No major comprehension difficulties emerged. Cronbach's alphas for the different dimensions run from 0.71 to 0.81.
30 months
Nurses' quality of working life (QoWL) - nurses
Time Frame: 30 months
Quality of working life (QoWL) will be measured with a scale developed by Elizur and Shye (70), translated and validated in French. The scale is composed of 16 items exploring different dimensions of QoWL : psychological (items 1-4), physical (items 5-8), social (items 9-12) and cultural (items 13-16). Respondents must choose from six answers on a Likert scale ranging from "a very large part" to "very little".
30 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemodyalisis patients' quality of life (QoL)
Time Frame: 30 months
Quality of life (QoL) of HD patients will be explored with a French version of the WHOQOL-BREF. This scale is a generic instrument that serves to explore perceived QoL and the impact of health problems on QoL. It comprises 26 items exploring four dimensions: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items). It also contains two items measuring overall QoL, which is an added advantage of this instrument. Respondents must choose from five responses on a Likert scale ranging from 0 (not at all) to 5 (completely). The WHOQOLBREF yields an overall "QoL profile" score on a scale of 0 to 100, as well as scores for each dimension. A high score indicates a high perceived QoL. The French version translated and validated, and has shown perfectly satisfactory psychometric properties, and good acceptability by the population with a non-response rate below 5%.
30 months
Nurse-patient relationship (NPR) - patients
Time Frame: 30 months
NPR will be explored with the French version (EIIP-70) (66) of the Caring Nurse-Patient Interaction Scale (CNPI-70) (for a description of dimensions, see Nurse section). Only the person addressed has been changed in order to adapt the items to the patient's viewpoint. The scale has been validated on a French population of patients living with HIV and presents perfectly satisfactory psychometric properties (Cronbach's alphas from 0.75 to 0.85). The scale allows HD patients to assess nurses' caring attitudes and behaviours.
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

July 24, 2018

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

September 13, 2017

First Submitted That Met QC Criteria

September 13, 2017

First Posted (Actual)

September 14, 2017

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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