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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05700929
Other study ID # 1047/136
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 14, 2022
Est. completion date November 30, 2024

Study information

Verified date January 2024
Source Universitätsklinikum Hamburg-Eppendorf
Contact Isabelle Scholl, Prof.Dr.
Phone +49 (0)40-7410-57135
Email i.scholl@uke.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Communication skills training for nurses
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.

Locations

Country Name City State
Germany University Medical Center Hamburg-Eppendorf Hamburg

Sponsors (1)

Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

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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