CommunicationKOMPATNCT05700929
Evaluation of a Communication Skills Training for Nurses
A study testing Communication skills training for nurses in people with Communication, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Communication
- What is being tested?
- Communication skills training for nurses
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteGermany
- Study dates
- 14 Nov 2022to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Little or no contact with patients in daily work, e.g. an operating room nurse or within the bed management
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
- Conditions
- Communication
- Being tested
- Communication skills training for nurses
- 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
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication skills training for nursesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Communication skills training | Experimental | 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. Receives: Behavioral: Communication skills training for nurses |
| Waitlist-control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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 (12)
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.
Measured: immediately after the training (t1) for the intervention group
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.
Measured: 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
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.
Measured: 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
Assessment of nurses' attitudes towards medical communication measured via the German version of the 12-item Attitudes towards medical communication scale (ATMC-G).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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.
Measured: four weeks after the training (t2) for the intervention and waitlist-control group
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).
Measured: 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
Depression and anxiety will be measured using the German version of the 4-item measure Patient Health Questionnaire 4 (PHQ-4).
Measured: 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
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).
Measured: 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)
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).
Measured: Change from baseline (t0) at four weeks after the training (t2) for the intervention and waitlist-control group
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start14 Nov 2022
- Primary completion31 Oct 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CommunicationStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabelle Scholl, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700929
- Sponsor's protocol ID
- 1047/136
- Acronym
- KOMPAT
- Status last verified
- Jul 2024
- First submitted
- 16 Nov 2022
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lindig A, Mielke K, Frerichs W, Collen K, Kriston L, Harter M, Scholl I. Evaluation of a patient-centered communication skills training for nurses (KOMPAT): study protocol of a randomized controlled trial. BMC Nurs. 2024 Jan 2;23(1):2. doi: 10.1186/s12912-023-01660-8.
PubMed 38163904
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Patient-centered Communication Skills Training for Nursing Professionals in Germany: A Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT05700929
- Acronym / sponsor ID
- KOMPAT / 1047/136
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Communication skills training | Experimental | Behavioral: Communication skills training for nursesThe 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. |
| Waitlist-control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Little or no contact with patients in daily work, e.g. an operating room nurse or within the bed management
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communication skills training for nursesAim 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. | Behavioural | Communication skills training |
Primary outcome
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".
12 secondary outcomes
Rating of the training
Time frame: 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
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
Attitudes towards medical communication
Time frame: 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
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
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
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
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
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
Experienced patient-centeredness (Covariate)
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Derived from this study: PubMed 38163904Lindig A, Mielke K, Frerichs W, Collen K, Kriston L, Harter M, Scholl I. Evaluation of a patient-centered communication skills training for nurses (KOMPAT): study protocol of a randomized controlled trial. BMC Nurs. 2024 Jan 2;23(1):2. doi: 10.1186/s12912-023-01660-8.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication skills training for nurses in people with Communication, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05700929, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.