TeamBaby - Safe, Digitally Supported Communication in Obstetrics and Gynecology
NCT03855735 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 424
Last updated 2025-02-19
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
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