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
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Related||Behavioral: Intervention Group (IG)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- 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.
- 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.
- 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.
- Proximal outcomes to the online training [ Time Frame: 16 months ]outcome expectancy, intentions, action and coping plans, behavior, self-efficacy, patient satisfaction, employee satisfaction
- Covariables of the training and preventable adverse events (pAEs) [ Time Frame: 16 months ]barriers and resources
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
|Contact: Sonia Lippke, Prof. Dr.||+49 421 firstname.lastname@example.org|
|Contact: Franziska M. Keller||+49 421 email@example.com|
|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 firstname.lastname@example.org|
|Universitätsklinikum Frankfurt; Klinik für Frauenheilkunde und Geburtshilfe||Recruiting|
|Contact: Frank Louwen, MD email@example.com|
|Contact: Johanna Dietl firstname.lastname@example.org|
|Principal Investigator:||Sonia Lippke, Prof. Dr.||Jacobs University Bremen, Germany|