- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03283891
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
Status
Completed
Conditions
Intervention / Treatment
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
-
-
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Genève, Switzerland
- Hôpitaux Universitaires de Genève (HUG)
-
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Jura
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Delémont, Jura, Switzerland
- Hopital du Jura
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Vallais
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Martigny, Vallais, Switzerland
- Hôpital du Valais - Martigny
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Monthey, Vallais, Switzerland
- Hôpital Riviera-Chablais (HRC)
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Sierre, Vallais, Switzerland
- Hôpital du Valais - Sierre
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Sion, Vallais, Switzerland
- Hôpital du Valais - Sion
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Vaud
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Lausanne, Vaud, Switzerland
- Centre Hospitalier Universitaire Vaudois (CHUV)
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Morges, Vaud, Switzerland
- Hôpital de Morges - Ensemble Hospitalier de la Côte
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Payerne, Vaud, Switzerland
- Hôpital Intercantonal de la Broye (HIB)
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Yverdon-les-Bains, Vaud, Switzerland
- Etablissements hospitaliers du Nord Vaudois (eHnv)
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-
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:
- have at least 6 months' work experience in the department;
- 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
- be at least 18 years of age and under active treatment for at least 6 months;
- understand and read French;
- 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
- being diagnosed with dementia
- 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:
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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".
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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.
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30 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Philippe Delmas, PhD, Haute Ecole de la Santé La Source
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.
General Publications
- Antonini M, Bellier-Teichmann T, O'reilly L, Cara C, Brousseau S, Weidmann J, Roulet-Schwab D, Ledoux I, Konishi M, Pasquier J, Delmas P. Effects of an educational intervention to strengthen humanistic practice on haemodialysis nurses' caring attitudes and behaviours and quality of working life: a cluster randomised controlled trial. BMC Nurs. 2021 Dec 20;20(1):255. doi: 10.1186/s12912-021-00729-6.
- Delmas P, O'Reilly L, Cara C, Brousseau S, Weidmann J, Roulet-Schwab D, Ledoux I, Pasquier J, Antonini M, Bellier-Teichmann T. Effects on nurses' quality of working life and on patients' quality of life of an educational intervention to strengthen humanistic practice among hemodialysis nurses in Switzerland: a protocol for a mixed-methods cluster randomized controlled trial. BMC Nurs. 2018 Nov 21;17:47. doi: 10.1186/s12912-018-0320-0. eCollection 2018.
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
Keywords
Other Study ID Numbers
- FNS 10001C_172588
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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