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

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



Sponsors


Source

Institut et Haute Ecole de la Santé la Source

Oversight Info

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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, we 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.

Overall Status

Enrolling by invitation

Start Date

2017-09-01

Completion Date

2019-07-01

Primary Completion Date

2019-07-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Nurse-patient relationship (NPR)
30 months
Nurses' team cohesion
30 months
Nurses' quality of working life (QoWL) - nurses
30 months

Secondary Outcome

Measure

Time Frame

Hemodyalisis patients' quality of life (QoL)
30 months
Nurse-patient relationship (NPR) - patients
30 months

Enrollment

135

Condition


Intervention

Intervention Type

Other

Intervention Name


Description

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

Arm Group Label

educational intervention


Eligibility

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

Gender

All

Minimum Age

N/A

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Philippe Delmas, PhD
Principal Investigator
Haute Ecole de la Santé La Source

Location

Facility

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

Location Countries

Country

Switzerland


Verification Date

2017-09-01

Lastchanged Date

2017-09-13

Firstreceived Date

2017-09-13

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Institut et Haute Ecole de la Santé la Source

Investigator Full Name

Philippe Delmas

Investigator Title

Inf, Ph.D, Ex.MBA., Professeur Ordinaire HES-SO


Keywords


Has Expanded Access

No

Number Of Arms

2

Arm Group

Arm Group Label

educational intervention

Arm Group Type

Experimental

Description

Various pedagogical activities to mobilise Watson's ten Carative Factors


Arm Group Label

control

Arm Group Type

No Intervention

Description

No intervention during the different times of measurement. Educational intervention will be delivered after the last measure.



Firstreceived Results Date

N/A

Acronym

ExpCare

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Intervention Model Description

Mixed methods cluster randomised controlled trial

Primary Purpose

Other

Masking

Single (Outcomes Assessor)



ClinicalTrials.gov processed this data on September 14, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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