Clinical trial NCT05700929: Evaluation of a Communication Skills Training for Nurses
Official title: Evaluation of a Patient-centered Communication Skills Training for Nursing Professionals in Germany: A Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Communication
Keywords: Nursing
Communication skills
Communication skills training
Patient-centered
Train-the-trainer
Health Services Research
Implementation Research
Hybrid type 1 effectiveness-implementation trial
Randomized controlled trial
Mixed Methods
Self-Efficacy
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a hybrid type 1 effectiveness-implementation trial, conducted as a two-armed randomized controlled trial including a comprehensive process evaluation for future implementation. After baseline assessment, participants will be randomized to the intervention group or the waitlist-control group. Randomization will be performed using stratified permuted block randomization. The waitlist-control group are offered to participate in the communication skills training after data collection has been finished.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The KOMPAT study aims to evaluate the effectiveness and feasibility of a needs-based communication skills training for nursing professionals in Germany and to derive recommendations for future long-term implementation. Therefore, a training program to foster communication skills of nursing professionals has been developed based on a previously conducted needs assessment and literature research. To evaluate the training a randomized controlled trail with a waitlist-control group will be conducted. It is aimed to include 180 nurses within the study, of which 90 nurse will be randomized in a stratified manner to the intervention group and 90 nurses will be randomized to the waitlist-control group. Outcomes will be assessed at baseline, post -training and 4-weeks follow-up. It is hypothesized that self-efficacy in communication with patients and further outcomes will be significantly higher among participants in the intervention group compared to participants of the waitlist-control group during post-training assessment and follow-up. The evaluation will be accompanied by a process evaluation. The training will be facilitated by a member of the research team and a nursing professional by applying the train-the-trainer approach. The KOMPAT study will be conducted at the University Medical Center Hamburg-Eppendorf.


Eligibility criteria: Inclusion Criteria:

* Nurses working at the participating departments of the University Medical Center Hamburg-Eppendorf
* Main part of daily work includes communication with patients
* Age ≥ 18 years
* Completed educational program as a nurse
* German-speaking

Exclusion Criteria:

* Little or no contact with patients in daily work, e.g. an operating room nurse or within the bed management

Primary outcomes:
measure: Self-efficacy regarding communication with patients
timeFrame: Change from baseline (t0) at immediately after the training (t1) (with t1 being the primary endpoint) and at four weeks after the training (t2) for the intervention and waitlist-control group.
Secondary outcomes:
measure: Rating of the training
timeFrame: immediately after the training (t1) for the intervention group
measure: Subjective knowledge about patient-centered communication
timeFrame: Change from baseline (t0) at immediately after the training (t1) and at four weeks after the training (t2) for the intervention and waitlist-control group
measure: Objective knowledge about patient-centered communication
timeFrame: Change from baseline (t0) at immediately after the training (t1) and at four weeks after the training (t2) for the intervention and waitlist-control group
measure: Attitudes towards medical communication
timeFrame: Change from baseline (t0) at four weeks after the training (t2) for the intervention and waitlist-control group
measure: Communication skills of nurses from external observers' perspective after participation in a SPA
timeFrame: four weeks after the training (t2) for the intervention and waitlist-control group
measure: Communication skills of nurses from simulation patients' perspective after participation in a SPA
timeFrame: four weeks after the training (t2) for the intervention and waitlist-control group
measure: Self-assessed communication skills from participants' perspective after participation in a SPA
timeFrame: four weeks after the training (t2) for the intervention and waitlist-control group
measure: Professional fulfillment
timeFrame: Change from baseline (t0) at immediately after the training (t1) and at four weeks after the training (t2) for the intervention and waitlist-control group
measure: Depression and anxiety
timeFrame: Change from baseline (t0) at immediately after the training (t1) and at four weeks after the training (t2) for the intervention and waitlist-control group
measure: Subjective working capacities
timeFrame: Change from baseline (t0) at immediately after the training (t1) and at four weeks after the training (t2) for the intervention and waitlist-control group
measure: Experienced patient-centeredness (Covariate)
timeFrame: Change from baseline (t0) at four weeks after the training (t2) for the intervention and waitlist-control group
measure: Impact of contamination (Covariate)
timeFrame: for the intervention group at baseline (t0) only; for the waitlist-control group at baseline (t0), immediately after the training (t1) and four weeks after the training (t2)
Other outcomes:
measure: Process evaluation
timeFrame: through study completion and until approximately June 2025
measure: Demographic items
timeFrame: baseline (t0) for the intervention and waitlist-control group
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
References: