Washington University School of Medicine
St Louis, Missouri, 63110, United States
NCT Number: NCT07742761
The primary objective of the study is to investigate the impact of an ambient AI scribe on clinicians' wellness and well-being outcomes; additionally, we also investigate how the use of the ambient AI scribe will lead to changes in documentation burden, clinical note characteristics and financial productivity.
This study is active but is not currently recruiting participants.
Notify MeAll sexes
Interventional
Not applicable
St Louis, Missouri, 63110, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-Residents who are apart of the Emergency Medicine Department
Clinicians will use an ambient AI scribe as part of routine clinical care. The AI scribe captures the patient-clinician conversation, generates a draft clinical note, and supports documentation in the electronic health record. Clinicians receive training before beginning use of the AI scribe. The intervention is introduced in three sequential waves using a stepped-wedge design, with all participants eventually receiving the intervention.
Time frame: From enrollment to the end of maintenance phase at 24 weeks
We will fit a linear model to describe the effect of Ambient tool introduction on our co-primary outcomes under the intention-to-treat (ITT) framework with a random effects structure to describe within provider variability. While we anticipate high or complete survey completion rates, in the event that not all surveys are completed and returned, we will perform a primary analysis on completed surveys only, and perform sensitivity analyses accounting for potentially systematic survey non-response bias using a response weighting strategy, using provider, scheduling, and patient encounter characteristics to create survey response weights (within each survey time period), then reweighting observations to account for non-response patterns. In analyses for both co-primary outcomes, we will perform Wald type hypothesis tests for inferences on the overall Ambient treatment effect and compare p-values to 0.05 / 2 to conservatively account for multiple comparisons using Bonferroni's method.
Time frame: From enrollment to the end of maintenance phase at 42 weeks
In exploratory analyses for all secondary outcomes, we will fit Bayesian generalized linear models with appropriate link functions and likelihood choices (ie, log and Poisson for count data, logit and Bernoulli for binary responses) to for each encounter, while accounting for serial correlation overall through time (indexed to the day) using an autoregressive modeling structure, within provider patterns using a provider level random intercept, weekday, weekend, and holiday effects using fixed effects terms, and specify a flexible interrupted time series treatment effect using a semi-parametric, thin plate spline to describe how the introduction of Ambient AI affects the relationship between providers and notes, and how that relationship evolves over time. In sensitivity analyses, we will additionally evaluate how these effects and their evolution may differ by treatment wave. All inferences will be based on describing the mean and 95% credible intervals for the treatment effect daily.
Washington University School of Medicine
Other
Acronym: EMPOWER
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.
Published trials that share one or more normalized conditions with this study.
NCT07311187
Well-being at Work
Bologna, Italy
View Trial DetailsNCT07366333
Well-being at Work
Aurora, Colorado, United States
View Trial DetailsNCT06724770
Behavior, Behavioral Symptoms
Elche, Alicante, Spain
View Trial DetailsNCT06867601
Behavior, Behavioral Symptoms
Bremen, Free Hanseatic City of Bremen, Germany
View Trial Details