TeamBaby - Safe, Digitally Supported Communication in Obstetrics and Gynecology

NCT03855735 | Completed

• 2 other identifiers: NCT0385573501VSF18023
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 2

Brief 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. 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. 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. 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

Keywords

Preventable adverse events; Patient safety; Core communication competences; Different communication models; HAPA; Participatory intervention development; Digitization; App; eHealth; Health services research

Outcome Measures

Primary Outcomes (3)

• Core competencies and preventable adverse events - specialists

  The core competencies of all specialists will improve measurably. Furthermore, the number of preventable adverse events (pAEs) and their associated costs should be significantly changed over time.

  16 Months

• Core competencies surrounding communication - patients and relatives

  It is expected that patients/accompanying persons in the intervention group will (1) measurably improve their communication competencies with skilled employees after the intervention compared to those giving birth/accompanying persons in the control group, and (2) a higher expectation of self-efficacy in communication with skilled employees will arise. In addition, it is expected that (3) the number and severity of preventable adverse events (pAEs) in the intervention group will be measurably reduced compared to the number and severity of preventable adverse events in the control group.

  16 Months

• Usability and effectiveness of the digital communication app

  The use of a digital communication app will lead to a significantly changed number, severity and cost of preventable adverse events (pAEs) in the intervention group compared to the intervention group without an app.

  16 Months

Secondary Outcomes (2)

• Proximal outcomes to the online training

  16 months

• Covariables of the training and preventable adverse events (pAEs)

  16 months

Study Arms (3)

TeamBaby Online Training Intervention Group Phase 2 (IG1)

EXPERIMENTAL

Those who give birth and relatives who have been arbitrarily assigned to the intervention group receive an interactive online training on different communication models and competencies (Phase 2).

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

No Intervention

NO INTERVENTION

Those who give birth and relatives who have been arbitrarily assigned to the control group do not receive any training on different communication models competencies and will not gain access to the digital app prior to giving birth.

TeamBaby App Training Intervention Group Phase 3 (IG2)

EXPERIMENTAL

Those who give birth and relatives who have been arbitrarily assigned to the intervention group will gain access to the digital app and receive a communication training via the app (Phase 3).

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

Interventions

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

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.

TeamBaby App Training Intervention Group Phase 3 (IG2); TeamBaby Online Training Intervention Group Phase 2 (IG1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Expectant mother or patient in gynecology and obstetrics or social support providers (spouse/partner, relative, close friend) to be recipient of the training
• Professional in a gynecology and obstetrics hospital to be trainer of the patients and the social support providers
• Aged 18 years and above
• Healthy volunteers
• Declaration of consent for participation in the study

You may not qualify if:

• Not proficient in the German language and/ or does not have the capability of writing
• Severe cognitive deficits (unable to read/write/answer questions) and impairments due to diagnosed brain injuries, neurological disorders, etc.
• Insufficient corrected eyesight (patients must be able to read on the cell phone)
• Participation in another research study or intervention trial conducted in the clinic
• Younger than 18 years
• High risk, emergency case
• Withdraw of consent for participation in the study at any point in time

Sponsors & Collaborators

• Jacobs University Bremen gGmbH: lead
• German Coalition for Patient Safety (Aktionsbündnis Patientensicherheit): collaborator
• Techniker Krankenkasse: collaborator
• University Hospital Ulm: collaborator
• The German Innovation Fund (Innovationsfonds): collaborator
• Goethe University: collaborator

Study Sites (2)

Universitaetsklinikum Ulm; Klinik fuer Frauenheilkunde und Geburtshilfe

Ulm, Baden-Wurttemberg, 89075, Germany

Location

Universitätsklinikum Frankfurt; Klinik für Frauenheilkunde und Geburtshilfe

Frankfurt, Germany

Location

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  BACKGROUND

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• Schmiedhofer M, Derksen C, Keller FM, Dietl JE, Haussler F, Strametz R, Koester-Steinebach I, Lippke S. Barriers and Facilitators of Safe Communication in Obstetrics: Results from Qualitative Interviews with Physicians, Midwives and Nurses. Int J Environ Res Public Health. 2021 Jan 21;18(3):915. doi: 10.3390/ijerph18030915.

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• Keller, F., Derksen, C., Schmiedhofer, M., Welp, A., Kötting, L. and Lippke, S., 2020. Patientensicherheit und wahrgenommene Risiken für Vermeidbare Unerwünschte Ereignisse aus Sicht von Patienten und Beschäftigten im Gesundheitswesen. Monitor Versorgungsforschung, 13(05/2020), pp.83-89. doi:http://doi.org/10.24945/MVF.05.20.1866-0533.2251

  RESULT

• Derksen C, Kotting L, Keller FM, Schmiedhofer M, Lippke S. Psychological Intervention to Improve Communication and Patient Safety in Obstetrics: Examination of the Health Action Process Approach. Front Psychol. 2022 Feb 18;13:771626. doi: 10.3389/fpsyg.2022.771626. eCollection 2022.

  PMID: 35250715 RESULT

• Huner B, Derksen C, Schmiedhofer M, Lippke S, Janni W, Scholz C. Preventable Adverse Events in Obstetrics-Systemic Assessment of Their Incidence and Linked Risk Factors. Healthcare (Basel). 2022 Jan 4;10(1):97. doi: 10.3390/healthcare10010097.

  PMID: 35052261 RESULT

• Keller FM, Derksen C, Kotting L, Schmiedhofer M, Lippke S. Development of the perceptions of preventable adverse events assessment tool (PPAEAT): measurement properties and patients' mental health status. Int J Qual Health Care. 2021 Apr 16;33(2):mzab063. doi: 10.1093/intqhc/mzab063.

  PMID: 33822086 RESULT

• Lippke S, Derksen C, Keller FM, Kotting L, Schmiedhofer M, Welp A. Effectiveness of Communication Interventions in Obstetrics-A Systematic Review. Int J Environ Res Public Health. 2021 Mar 5;18(5):2616. doi: 10.3390/ijerph18052616.

  PMID: 33807819 RESULT

• Schmiedhofer M, Derksen C, Dietl JE, Haussler F, Louwen F, Huner B, Reister F, Strametz R, Lippke S. Birthing under the Condition of the COVID-19 Pandemic in Germany: Interviews with Mothers, Partners, and Obstetric Health Care Workers. Int J Environ Res Public Health. 2022 Jan 28;19(3):1486. doi: 10.3390/ijerph19031486.

  PMID: 35162509 RESULT

• Kotting L, Anand-Kumar V, Keller FM, Henschel NT, Lippke S. Effective Communication Supported by an App for Pregnant Women: Quantitative Longitudinal Study. JMIR Hum Factors. 2024 Apr 26;11:e48218. doi: 10.2196/48218.

  PMID: 38669073 DERIVED

• Kotting L, Derksen C, Keller FM, Lippke S. Comparing the Effectiveness of a Web-Based Application With a Digital Live Seminar to Improve Safe Communication for Pregnant Women: 3-Group Partially Randomized Controlled Trial. JMIR Pediatr Parent. 2023 Jul 24;6:e44701. doi: 10.2196/44701.

  PMID: 37486755 DERIVED

• Huner B, Derksen C, Schmiedhofer M, Lippke S, Riedmuller S, Janni W, Reister F, Scholz C. Reducing preventable adverse events in obstetrics by improving interprofessional communication skills - Results of an intervention study. BMC Pregnancy Childbirth. 2023 Jan 23;23(1):55. doi: 10.1186/s12884-022-05304-8.

  PMID: 36690974 DERIVED

• Derksen C, Dietl JE, Haeussler FE, Steinherr Zazo M, Schmiedhofer M, Lippke S. Behavior change training for pregnant women's communication during birth: A randomized controlled trial. Appl Psychol Health Well Being. 2023 Aug;15(3):865-883. doi: 10.1111/aphw.12413. Epub 2022 Nov 15.

  PMID: 36380576 DERIVED

• Keller FM, Dahmen A, Derksen C, Kotting L, Lippke S. Psychosomatic Rehabilitation Patients and the General Population During COVID-19: Online Cross-sectional and Longitudinal Study of Digital Trainings and Rehabilitation Effects. JMIR Ment Health. 2021 Aug 26;8(8):e30610. doi: 10.2196/30610.

  PMID: 34270444 DERIVED

Related Links

• Project description and outline of partners

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sonia Lippke, Prof. Dr.

  Jacobs University Bremen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Professor of Health Psychology & Behavioral Medicine

Model Details: Parallel design for Phase 2 and sequential design in Phase 3

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: February 27, 2019
• Study Start: September 2, 2019
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)