NCT05700929

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

2 years

First QC Date

November 16, 2022

Last Update Submit

July 30, 2024

Conditions

Keywords

NursingCommunication skillsCommunication skills trainingPatient-centeredTrain-the-trainerHealth Services ResearchImplementation ResearchHybrid type 1 effectiveness-implementation trialRandomized controlled trialMixed MethodsSelf-Efficacy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Rating of the training

    immediately after the training (t1) for the intervention group

  • Subjective knowledge about patient-centered communication

    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

    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

    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

    four weeks after the training (t2) for the intervention and waitlist-control group

  • +7 more secondary outcomes

Other Outcomes (2)

  • Process evaluation

    through study completion and until approximately June 2025

  • Demographic items

    baseline (t0) for the intervention and waitlist-control group

Study Arms (2)

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.

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.

Interventions

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.

Communication skills training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Communication

Interventions

Nurses

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Dr.

Study Record Dates

First Submitted

November 16, 2022

First Posted

January 26, 2023

Study Start

November 14, 2022

Primary Completion

October 31, 2024

Study Completion

November 30, 2024

Last Updated

August 1, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations