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Patient-Centered CareExpCareNCT03283891

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

A study testing Educational intervention - humanistic nursing practice in people with Patient-Centered Care, run by Institut et Haute Ecole de la Santé la Source at 10 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Patient-Centered Care
What is being tested?
Educational intervention - humanistic nursing practice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
241 participants
Where
10 sitesSwitzerland
Study dates
1 Sep 2017to 1 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Switzerland10 sites

  • Hôpital du Jura

    Delémont, Canton of Jura

  • Hôpitaux Universitaires de Genève (HUG)

    Geneva

  • Centre hospitalier universitaire vaudois (CHUV)

    Lausanne, Canton of Vaud

  • Hôpital du Valais - Martigny

    Martigny-Ville, Valais

  • Hôpital Riviera-Chablais (HRC)

    Monthey, Valais

  • Hôpital de Morges - Ensemble hospitalier de la Côte

    Morges, Canton of Vaud

  • Hôpital intercantonal de la Broye (HIB)

    Payerne, Canton of Vaud

  • Hôpital du Valais - Sierre

    Sierre, Valais

  • Hôpital du Valais - Sion

    Sion, Valais

  • Établissements hospitaliers du Nord vaudois (eHnv)

    Yverdon-les-Bains, Canton of Vaud

Other trials in Switzerland

About this study

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

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.

Being tested
Educational intervention - humanistic nursing practice
Keywords
Educational intervention, Watson's theory of human caring, Quality of working life of haemodialysis nurses, Quality of life of haemodialysis patients

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational intervention - humanistic nursing practiceOther

    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
Study groups in NCT03283891
Study groupRoleWhat they receive
educational interventionExperimentalVarious pedagogical activities to mobilise Watson's ten Carative Factors
Receives: Other: Educational intervention - humanistic nursing practice
controlNo interventionNo intervention during the different times of measurement. Educational intervention will be delivered after the last measure.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nurse-patient relationship (NPR)

    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).

    Measured: 30 months

  2. Nurses' team cohesion

    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.

    Measured: 30 months

  3. Nurses' quality of working life (QoWL) - nurses

    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".

    Measured: 30 months

Secondary outcomes (2)

  1. Hemodyalisis patients' quality of life (QoL)

    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%.

    Measured: 30 months

  2. Nurse-patient relationship (NPR) - patients

    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.

    Measured: 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2017
  2. Study start1 Sep 2017
  3. Primary completion24 Jul 2018
  4. Study completion1 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Mixed methods cluster randomised controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
241 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03283891
Sponsor's protocol ID
FNS 10001C_172588
Acronym
ExpCare
Status last verified
Feb 2021
First submitted
13 Sep 2017
Last updated
3 Feb 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 34930206

  • 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.

    PubMed 30479561

Questions about this trial

What is this clinical trial studying?

A study testing Educational intervention - humanistic nursing practice in people with Patient-Centered Care, run by Institut et Haute Ecole de la Santé la Source at 10 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nurse-patient relationship (NPR) (time frame: 30 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03283891, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.

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