Evaluation of a Communication Skills Training for Nurses (KOMPAT)

July 30, 2024 updated by: Isabelle Scholl, Universitätsklinikum Hamburg-Eppendorf

Evaluation of a Patient-centered Communication Skills Training for Nursing Professionals in Germany: A Randomized Controlled Trail

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Interventional

Enrollment (Actual)

207

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

      • Hamburg, Germany, 20246
        • University Medical Center Hamburg-Eppendorf

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Communication skills training
The intervention is a one-day face-to-face training to foster patient-centered communication skills of nursing professionals at the University Medical Center Hamburg-Eppendorf, Germany. The training is developed based on results of a previously conducted needs assessment with nurses, medical assistants and nursing service managers as well as literature research and will be rolled out after baseline assessment and randomization.
Aim of the developed training will be to foster patient-centered communication skills of nursing professionals in Germany. The training consists of four modules in which participating nurses will get information regarding patient-centeredness and general communication techniques. Participants will also learn how to response to patients in escalating situations and how to communicate with seriously ill or dying patients. The underlying framework for the training is the Calgary-Cambridge Guide, a well-known model for structuring conversation with patients. Different didactic techniques (i.e. roll-play, video sequences, group discussion) will be applied. The training will be provided in small groups of 10-14 participants each. Two facilitators will give the training, one of them being a nursing professional trained according to the train-the-trainer approach, the other being a member of the research group, who was involved in the development of the training.
No Intervention: Waitlist-control group
Participants of the waitlist-control group receive no specific study related intervention. Participants of this group will be offered a communication skills training after complete data collection of all participants of the RCT has been finished.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-efficacy regarding communication with patients
Time Frame: 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.
Description: Self-efficacy of nurses in the context of communication with their patients will be measured by the German version of the 12-item Self-Efficacy Scale (SE-12-G). Items on this one-dimensional scale can be answered on a scale from 1 ("very uncertain") to 10 ("very certain") with an additional option to rate items as "not relevant".
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rating of the training
Time Frame: immediately after the training (t1) for the intervention group
Rating of the training by participating nurses according to the trainings' content, used materials and didactic, measured by a short self-developed scale adapted from previous studies on the evaluation of communication skills trainings at the University Medical Center Hamburg-Eppendorf.
immediately after the training (t1) for the intervention group
Subjective knowledge about patient-centered communication
Time Frame: 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
Assessment of nurses' subjective knowledge regarding patient-centered communication topics, which will be conveyed in the trainings, measured by a short self-developed scale adapted from a previous study of the research team and adapted to the content of the communication skills training.
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
Objective knowledge about patient-centered communication
Time Frame: 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
Assessment of nurses' objective knowledge regarding patient-centered communication topics, which will be conveyed in the trainings, measured by several multiple choice questions developed according to the content of the communication skills training.
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
Attitudes towards medical communication
Time Frame: Change from baseline (t0) at four weeks after the training (t2) for the intervention and waitlist-control group
Assessment of nurses' attitudes towards medical communication measured via the German version of the 12-item Attitudes towards medical communication scale (ATMC-G).
Change from baseline (t0) at four weeks after the training (t2) for the intervention and waitlist-control group
Communication skills of nurses from external observers' perspective after participation in a SPA
Time Frame: four weeks after the training (t2) for the intervention and waitlist-control group
Objective rating of nurses' communication skills measured via Standardized Patient Assessments (SPAs). Content of SPAs were developed according to the content of the communication skills training. Ratings will be conducted by one trained member of the research team who has not previously trained the participants. Additionally, the level of anxiety associated with performing in a SPA will be assessed via the subscale 'cognitive anxiety' and the subscale 'physiological anxiety' of the Performance Text Anxiety questionnaire (PTA).
four weeks after the training (t2) for the intervention and waitlist-control group
Communication skills of nurses from simulation patients' perspective after participation in a SPA
Time Frame: four weeks after the training (t2) for the intervention and waitlist-control group
After SPAs, simulation patients will assess their perceived patient-centeredness during the SPA situation with the participating nurse using items of the dimensions 'communication' and 'patient-centerdness' of the German measure Experienced Patient-Centeredness Questionnaire (EPAT).
four weeks after the training (t2) for the intervention and waitlist-control group
Self-assessed communication skills from participants' perspective after participation in a SPA
Time Frame: four weeks after the training (t2) for the intervention and waitlist-control group
After SPAs, the participating nurses will self-assess their perceived communication skills via several items of the long version of the German measure Experienced Patient-Centeredness Questionnaire (EPAT), adapted for healthcare professionals.
four weeks after the training (t2) for the intervention and waitlist-control group
Professional fulfillment
Time Frame: 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
Job-related psychological burden of participating nurses including professional fulfillment, work exhaustion, interpersonal disengagement and overall burnout, measured via the German version of the 16-item Professional Fulfillment Index (PFI-G).
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
Depression and anxiety
Time Frame: 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
Depression and anxiety will be measured using the German version of the 4-item measure Patient Health Questionnaire 4 (PHQ-4).
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
Subjective working capacities
Time Frame: 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
Subjective working capacities of participating nurses, measured via three items covering the first two dimensions of the German version of the Work Ability Index (WAI).
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
Experienced patient-centeredness (Covariate)
Time Frame: Change from baseline (t0) at four weeks after the training (t2) for the intervention and waitlist-control group
Experienced person-centered climate on the wards, assessed by healthcare professionals working on the wards, measured via an adapted version of the German 16-item measure Experienced Patient-Centeredness Questionnaire (EPAT).
Change from baseline (t0) at four weeks after the training (t2) for the intervention and waitlist-control group
Impact of contamination (Covariate)
Time Frame: 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)
The measure the extent to which participants have received information about the training content prior to participation or for the waitlist-control group during all measurement points from participants, who participated already in the training, a self-developed item on the impact of contamination will be used.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic items
Time Frame: baseline (t0) for the intervention and waitlist-control group
Assessment of basic demographic information including age, sex, function, work experience, previous experience with communication skills trainings .
baseline (t0) for the intervention and waitlist-control group
Process evaluation
Time Frame: through study completion and until approximately June 2025
Assessment of the implementation process applying the Consolidated Framework for Implementation Research (CFIR) to describe fidelity and reach by documenting the implementation of the study, taking field notes by taking field notes while conducting the study as well as acceptability and appropriateness of the intervention by conducting semi-structured interviews with relevant stakeholders including non-participants of the study.
through study completion and until approximately June 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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.

Helpful Links

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)

November 14, 2022

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

November 16, 2022

First Submitted That Met QC Criteria

January 18, 2023

First Posted (Actual)

January 26, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2024

Last Update Submitted That Met QC Criteria

July 30, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

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

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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