University Hospital Tübingen
Tübingen, Baden-Wurttemberg, 72076, Germany
NCT Number: NCT07778251
A major challenge in health care is equipping health professionals with skills to conduct sensitive conversations which is of importance in the treatment of patients suffering from stigmatized health behaviors such as addiction-related diseases. Alcohol use during pregnancy can cause adverse outcomes for the newborns. Therefore, sensitive conversations with pregnant women conducted by various health professionals who are in contact with them, is of importance. E-learning programs are a good option to teach health professionals with various background how to conduct sensitive conversations, using Motivational Interviewing.
The goal of this clinical trial is to learn if the e-learning intervention can improve counseling about alcohol use in pregnancy in heathcare professionals like physicians, midwifes, social workers and others. The main questions it aims to answer is:
* Can the e-learning intervention lead to more conversations about alcohol use in pregnancy ? This is being operationalized as follows: Do health professionals address womens' alcohol use more frequently after completion of the e-learning? * Does the e-learning additionally lead to higher values of the following variables (secondary outcomes): knowledge on alcohol use in pregnancy, communication skills, confidence, actual and desired conversation duration?
To evaluate these research questions, the study contains two groups: an intervention group receiving the intervention (getting access to the e-learning for four weeks), and a waitlist-control-group which first has a waiting period and later receives the intervention as an incentive. The study has two main measurement point: at baseline (prior to the intervention respectively the waiting period), and after the intervention respectively the waiting period. The waitlist-control group has an additional measurement point after completion of the e-learning.
The main hypothesis is that the intervention group shows a higher increase in the alcohol discussion proportion than the waitlist control group (using the measurement point before the e-learning). We therefore expect a significant group-time interaction in the planned repeated-measures ANOVAs for all variables.
Participants were asked to complete online questionnaires before assignment to the intervention or waitlist control group and after completing the intervention or the waiting period, respectively. Participants in the intervention group were asked to complete an approximately 8-hour e-learning intervention within four weeks, covering background knowledge on alcohol use during pregnancy and communication skills, including motivational interviewing, with interactive case-based exercises and two assessments. Participants in the waitlist control group received access to the e-learning intervention after a two-month waiting period.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Tübingen, Baden-Wurttemberg, 72076, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
An asynchronous interprofessional e-learning program designed to improve knowledge, communication skills, and reflective practice regarding alcohol use during pregnancy and stigma. The program comprises three modules: (1) background knowledge on alcohol use in pregnancy, fetal alcohol spectrum disorders, stigma, and reasons for continued alcohol use; (2) communication skills training based on motivational interviewing principles; and (3) interactive case-based learning. Educational strategies include expert videos, quizzes, reflective exercises addressing personal attitudes and potential stigmatizing beliefs, and twelve interactive patient scenarios. The estimated completion time is approximately eight hours.
Time frame: At enrollment and after completion of the e-learning intervention/after 2 months on the waiting list
Description: alcohol discussion proportion means the number of pregnant women the health professionals asked about their alcohol consumption in the previous week. To account for different amounts of women seen in a week, the proportion is calculated as a quotient as the number of pregnant women asked about their alcohol use divided by the total number of women seen in the previous week. Both numbers are self-reported by study participants as part of the web-based questionnaires.
Time frame: At enrollment and after completion of the e-learning intervention/after 2 months on the waiting list
self-rated knowledge regarding risks and consequences of alcohol use during pregnancy. The variable is assessed on a 10-point Likert scale (0: no knowledge; 10: very high knowledge). This item was part of the web-based questionnaire.
Time frame: At enrollment and after completion of the e-learning intervention/after 2 months on the waiting list
This outcome describes health professionals' self-rated communication skills in the professional context which means their perceived ability to have effective, sensitive, patient-centered conversation with their patients/clients. This variable is answered on a 4-point Likert scale (1: sufficient; 4 very good). It is also part of the web-based questionnaires.
Time frame: At enrollment and after completion of the e-learning intervention/after 2 months on the waiting list
This outcome measure describes health professionals' self-rated confidence in discussing alcohol use during pregnancy with pregnant women they face in their clinical routine. This item is answered on a 4-point Likert scale (1: very unconfident; 4: very confident) and also part of the web-based questionnaires.
Time frame: At enrollment and after completion of the e-learning intervention/after 2 months on the waiting list
Self-reported average actual duration (in minutes) of conversations on alcohol use during pregnancy. Also part of the web-based questionnaires.
Time frame: At enrollment and after completion of the e-learning intervention/after 2 months on the waiting list
self-reported desired duration (in minutes) on conversation on alcohol use in pregnancy. This should be an indicator of the perceived relevance of the topic. This variable is also assessed as part of the web-based questionnaires.
University Hospital Tuebingen
Other
Understanding, Supporting, Motivating - Together for an Alcohol-Free Pregnancy
Acronym: ELAS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.