TeamBaby - Safe, Digitally Supported Communication in Obstetrics and Gynecology

NCT03855735 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 424

Last updated 2025-02-19

No results posted yet for this study

Summary

The purpose of this project with obstetric healthcare workers, pregnant women and their relatives is to improve communication between all parties involved in order to increase sustainable patient safety. To this end, clinical staff, expectant mothers and their partners as well as relatives will be trained in personal sessions and through digital interventions. The aim is to improve their ability to communicate more confidently with each other. In addition, an app will be developed to support all participants in their communication with each other and in overcoming difficulties in everyday hospital life. The project contributes to reduce the frequency of preventable adverse events (pAEs) in gynecology and obstetrics and to increase patients' satisfaction with their treatment. Data will be collected in three study phases:

1. Implementation phase - Training for obstetric healthcare workers at two German university hospitals which will be developed and implemented based on observations, interviews, and focus groups and pre-experimental study with pre/post-test (questionnaires for participants, interviews). To evaluate patient safety, an analysis of hospital data will be conducted incl. retrospective cohort study;
2. Effectiveness study with randomized controlled study design (questionnaires and interviews). In the intervention group, pregnant women and their relatives will be trained in safe communication;
3. Implementation of an app (evaluated via questionnaires, observations, interviews, focus groups). Women who receive the training via the app will be compared to the historical control group as case-control study (questionnaires, interviews, analysis of hospital data).

Conditions

  • Pregnancy Related

Interventions

BEHAVIORAL

TeamBaby Online Communication Training (IG1) and TeamBaby Web-App Communication Training (IG2)

The developed short manual for the teaching of different communication models competences will enable those who have been arbitrarily assigned to the intervention group and their relatives to develop secure communication competences (Phase 2). In Phase 3, the intervention group will have access to the digital app.

Sponsors & Collaborators

  • German Coalition for Patient Safety (Aktionsbündnis Patientensicherheit)

    collaborator UNKNOWN
  • Techniker Krankenkasse

    collaborator OTHER
  • University Hospital Ulm

    collaborator OTHER
  • The German Innovation Fund (Innovationsfonds)

    collaborator UNKNOWN
  • Goethe University

    collaborator OTHER
  • Jacobs University Bremen gGmbH

    lead OTHER

Principal Investigators

  • Sonia Lippke, Prof. Dr. · Jacobs University Bremen, Germany

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-02
Primary Completion
2023-03-30
Completion
2023-03-30

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03855735 on ClinicalTrials.gov