The steps outlined below will guide prospective sites through the entire enrollment and setup process for participating in PROMPT Study via the PACE Registry. For a downloadable version of the steps for enrollment, click here.
The PROMPT (PONV Rescue Outcomes after AMisulPride Treatment) Study is an observational, retrospective, registry-based study that will collect and analyze real-world evidence on the presentation, evaluation, and rescue treatment of post-operative nausea and vomiting.
PROMPT is a registry-based study that will be managed through the Perioperative and Anesthesia Care Explorer (PACE) Registry. PACE delivers clinically-rich, real-world evidence hospitals can use to understand their outcomes, advance research, and improve patient health after surgery.
Data for the PROMPT Study will be collected from de-identified electronic health records into the PACE Registry and compiled and analyzed by an independent data science company, ArborMetrix.
PROMPT is designed to identify current practice patterns and trends in the treatment of PONV. While there is no predefined hypothesis regarding the magnitude of efficacy or safety of various treatment regimens, they will be compared using established statistical methods for observational studies.
PROMPT will seek to provide insight into pharmacologic treatment for PONV related to clinical and economic outcomes in a real-world environment.
Specifically, PROMPT will examine patients in the PACU who receive amisulpride as a treatment for PONV. PROMPT will compare patient outcomes before (Cohort 1 – Standard of Care rescue anti-emetics) and after implementation of amisulpride as rescue treatment according to the package labeling (Cohort 2 – intravenous amisulpride rescue treatment).
The program design will involve deidentified, retrospective data collection from standard hospital system electronic health records for the duration necessary to collect at least 20,000 individual patient EHRs (at least 10,000 in each Cohort).
PROMPT is sponsored by Acacia Pharma.
The target timeline for baseline data collection for Cohort 1 will attempt to avoid time periods of peak COVID activity due to reduced surgical volume. Data collection will likely commence in the second half of 2021. Ideal data collection per site is 1000 cases for Cohort 1 and 1000 cases for Cohort 2 over a twelve-month time period.
Sites interested in participating will be willing to meet these and other minimum criteria and be able to complete the necessary steps for contracting, data integration, and Institutional Review Board approval within 6 months of joining.
De-identified data for the PROMPT Study will be retrieved from the Electronic Health Record, Administrative and Practice Management Systems, and the Electronic Anesthesia Record.
The data dictionary for the PROMPT Study contains thousands of data elements describing details related to patients, surgery type, anesthesia type, anesthesia technique, administered medications, adverse events, routine events, and transition times. The data dictionary functions as a tool for mapping data retrieved from a hospital to specific clinical metrics that are built upon an analytic engine capable of producing real-time insights from ingested data, and inform the development of the study measures:
Some of the clinical measures that will be viewable in the PROMPT Study include: