"Sufficiency, Accuracy, Clarity, Contextualization, and Interpersonal Adaptation - Safe, Digitally Supported Communication in Gynecology and Obstetrics: TeamBaby"
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 424
- Locations
- 3
- Primary Endpoint
- Core competencies and preventable adverse events - specialists
Study Overview
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:
- 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;
- 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;
- 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).
Detailed Description
Phase 1:
The concept of the needs assessment is based on a previous approach, which aimed to implement an intervention to increase the safety of patient transfers in intensive care units. This should lead to a comprehensive understanding of the beneficial and inhibitory conditions as well as potentials for the implementation of the intervention in the field (e.g., how different communication techniques can be integrated beyond training into clinical practice). Observations for the ethnographic analyses are recorded in a standardized observation protocol. Focus groups and interviews are conducted with partially standardized guidelines with at least one person from each occupational group in order to gain as comprehensive an impression as possible of possible resources and barriers for the implementation of the intervention. The data will then be analyzed in terms of content using an inductive approach and used to develop the training. Migration background will be considered exploratively in the data collection and testing as well as participatory in the app development (i.e. it will be ensured that patients and accompanying persons with migration background will also be included in the development). Different communication models competencies and tailoring based on the Health Action Process Approach (HAPA) will also be integrated into the training and app intervention. A short manual for practical support and written documentation of the training process will be prepared, also to avoid failure of implementation. The online training will be offered in the pre-experimental study to all professionals at both intervention sites. The aim is to investigate the connection between the staff trainings and preventable Adverse Events (pAEs) that are compared between the year 2018 (before the staff trainings) and 2020 (after the staff trainings), to observe mechanisms of action and to create a basis for the implementation of phase 2.
Additional remark 23/06/22: The paper comparing pAEs between 2018 and 2020 is currently under review.
The study regarding the questionnaire evaluation has a one-group, pre-/post-design. The study includes all specialists (e.g. doctors, nurses, midwives, obstetricians) at both locations with a total of N = 140 participants. Specialists are trained in interdisciplinary groups of 10 to 12 participants.
Additional remark 23/06/22: The paper concerning the evaluation of communication behavior and behavioral factors associated with this behavior has been published.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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.
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.
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.
Secondary Outcomes
- Proximal outcomes to the online training(16 months)
- Covariables of the training and preventable adverse events (pAEs)(16 months)
Investigators
Prof. Dr. Sonia Lippke
Principal Investigator and Professor of Health Psychology & Behavioral Medicine
Jacobs University Bremen gGmbH