Communication Clinical Trial
— KOMPATOfficial title:
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.
Status | Recruiting |
Enrollment | 180 |
Est. completion date | November 30, 2024 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Medical Center Hamburg-Eppendorf | Hamburg |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Process evaluation | 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 2024 | |
Other | Demographic items | 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 | |
Primary | Self-efficacy regarding communication with patients | 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 | Rating of the training | 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 | |
Secondary | Subjective knowledge about patient-centered communication | 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 | |
Secondary | Objective knowledge about patient-centered communication | 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 | |
Secondary | Attitudes towards medical communication | 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 | |
Secondary | Communication skills of nurses from external observers' perspective after participation in a SPA | 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 | |
Secondary | Communication skills of nurses from simulation patients' perspective after participation in a SPA | 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 | |
Secondary | Self-assessed communication skills from participants' perspective after participation in a SPA | 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 | |
Secondary | Professional fulfillment | 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 | |
Secondary | Depression and anxiety | 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 | |
Secondary | Subjective working capacities | 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 | |
Secondary | Experienced patient-centeredness (Covariate) | 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 | |
Secondary | Impact of contamination (Covariate) | 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) |
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