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Communication and Patient Safety in Gynecology and Obstetrics - Study Protocol of an Intervention Study (TeamBaby)

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ClinicalTrials.gov Identifier: NCT03855735
Recruitment Status : Recruiting
First Posted : February 27, 2019
Last Update Posted : August 28, 2020
Sponsor:
Collaborators:
Aktionsbündnis Patientensicherheit
Techniker Krankenkasse
University Hospital Ulm
The Innovation Fund
University Hospital, Frankfurt
Information provided by (Responsible Party):
Prof. Dr. Sonia Lippke, Jacobs University Bremen gGmbH

Brief Summary:
The purpose of this project with pregnant women and their relatives is to improve communication between all parties involved in order to increase sustainable patient's safety. To this end, clinical staff, expectant mothers and their partners as well as relatives will be trained in personal sessions. 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 - online training (observations, interviews, focus groups) incl. retrospective cohort study and pre-experimental study pre/post-test (interviews, analysis of hospital data); 2. effectiveness study with randomized controlled study design (interviews); 3. implementation of the app (observations, interviews, focus groups) as well as case-control study (interviews, analysis of hospital data).

Condition or disease Intervention/treatment Phase
Pregnancy Related Behavioral: Intervention Group (IG) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: "Sufficiency, Accuracy, Clarity, Contextualization, and Interpersonal Adaptation - Safe, Digitally Supported Communication in Gynecology and Obstetrics: TeamBaby"
Actual Study Start Date : September 2, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Patient Safety

Arm Intervention/treatment
Experimental: Intervention Group (IG)
Those who give birth and relatives who have been arbitrarily assigned to the control group receive online training on different communication models competencies and will gain access to the digital app.
Behavioral: Intervention Group (IG)
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. The intervention group will also have access to the digital app.

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. The control group will receive a paper-pencil version.



Primary Outcome Measures :
  1. Core competencies and preventable adverse events - specialists [ Time Frame: 16 Months ]
    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.

  2. Core competencies surrounding communication - patients and relatives [ Time Frame: 16 Months ]
    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.

  3. Usability and effectiveness of the digital communication app [ Time Frame: 16 Months ]
    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.


Secondary Outcome Measures :
  1. Proximal outcomes to the online training [ Time Frame: 16 months ]
    outcome expectancy, intentions, action and coping plans, behavior, self-efficacy, patient satisfaction, employee satisfaction

  2. Covariables of the training and preventable adverse events (pAEs) [ Time Frame: 16 months ]
    barriers and resources



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03855735


Contacts
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Contact: Sonia Lippke, Prof. Dr. +49 421 200-4730 s.lippke@jacobs-university.de
Contact: Franziska M. Keller +49 421 200-4721 f.keller@jacobs-university.de

Locations
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Germany
Universitaetsklinikum Ulm; Klinik fuer Frauenheilkunde und Geburtshilfe Recruiting
Ulm, Baden-Württemberg, Germany, 89075
Contact: Frank Reister, MD       Frank.Reister@uniklinik-ulm.de   
Contact: Freya Häußler       haeussler@aps-ev.de   
Universitätsklinikum Frankfurt; Klinik für Frauenheilkunde und Geburtshilfe Recruiting
Frankfurt, Germany
Contact: Frank Louwen, MD       louwen@em.uni-frankfurt.de   
Contact: Johanna Dietl       dietl@aps-ev.de   
Sponsors and Collaborators
Jacobs University Bremen gGmbH
Aktionsbündnis Patientensicherheit
Techniker Krankenkasse
University Hospital Ulm
The Innovation Fund
University Hospital, Frankfurt
Investigators
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Principal Investigator: Sonia Lippke, Prof. Dr. Jacobs University Bremen, Germany
Additional Information:
Publications:
Schrappe M. APS-Weißbuch Patientensicherheit. Sicherheit in der Gesundheitsversorgung: neu denken, gezielt verbessern [APS Report on Patient safety]. 1st ed. Berlin: Medizinisch Wissenschaftliche Verlagsgesellschaft; 2018.

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Responsible Party: Prof. Dr. Sonia Lippke, Principal Investigator and Professor of Health Psychology & Behavioral Medicine, Jacobs University Bremen gGmbH
ClinicalTrials.gov Identifier: NCT03855735    
Other Study ID Numbers: 01VSF18023 ( Other Grant/Funding Number: The Federal Joint Committee (G-BA) )
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. Sonia Lippke, Jacobs University Bremen gGmbH:
Preventable adverse events
Patient safety
Core communication competences
Different communication models
HAPA
Participatory intervention development
Digitization
App
eHealth
Health services research