Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03283891
Recruitment Status : Completed
First Posted : September 14, 2017
Last Update Posted : February 3, 2021
Sponsor:
Collaborators:
Universite du Quebec en Outaouais
Université de Sherbrooke
School of Management and Engineering Vaud
Université de Montréal
Lausanne University Hospital (CHUV)
Swiss National Science Foundation
Information provided by (Responsible Party):
Philippe Delmas, Institut et Haute Ecole de la Santé la Source

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Patient-Centered Care Other: Educational intervention - humanistic nursing practice Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 241 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Mixed methods cluster randomised controlled trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : July 24, 2018
Actual Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: educational intervention
Various pedagogical activities to mobilise Watson's ten Carative Factors
 Other: Educational intervention - humanistic nursing practice

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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".


Secondary Outcome Measures :
  1. 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%.

  2. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03283891


Locations
Layout table for location information
Switzerland
Hôpital du Jura
Delémont, Jura, Switzerland
Hôpital du Valais - Martigny
Martigny, Vallais, Switzerland
Hôpital Riviera-Chablais (HRC)
Monthey, Vallais, Switzerland
Hôpital du Valais - Sierre
Sierre, Vallais, Switzerland
Hôpital du Valais - Sion
Sion, Vallais, Switzerland
Centre hospitalier universitaire vaudois (CHUV)
Lausanne, Vaud, Switzerland
Hôpital de Morges - Ensemble hospitalier de la Côte
Morges, Vaud, Switzerland
Hôpital intercantonal de la Broye (HIB)
Payerne, Vaud, Switzerland
Établissements hospitaliers du Nord vaudois (eHnv)
Yverdon-les-Bains, Vaud, Switzerland
Hôpitaux Universitaires de Genève (HUG)
Genève, Switzerland
Sponsors and Collaborators
Institut et Haute Ecole de la Santé la Source
Universite du Quebec en Outaouais
Université de Sherbrooke
School of Management and Engineering Vaud
Université de Montréal
Lausanne University Hospital (CHUV)
Swiss National Science Foundation
Investigators
Layout table for investigator information
Principal Investigator: Philippe Delmas, PhD Haute Ecole de la Santé La Source
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Philippe Delmas, Inf, Ph.D, Ex.MBA., Professeur Ordinaire HES-SO, Institut et Haute Ecole de la Santé la Source
ClinicalTrials.gov Identifier: NCT03283891    
Other Study ID Numbers: FNS 10001C_172588
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Philippe Delmas, Institut et Haute Ecole de la Santé la Source:
Educational intervention
Watson's theory of human caring
Quality of working life of haemodialysis nurses
Quality of life of haemodialysis patients