Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04954365 |
| Other study ID # |
PROMPT |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2022 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
April 2023 |
| Source |
Acacia Pharma Ltd |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
PROMPT (PONV Rescue Outcomes after AMisulPride Treatment) is an observational Phase IV study
designed to evaluate real-world evidence in relation to the care continuum of Post Operative
Nausea and Vomiting (PONV), as well as the effectiveness and safety of common pharmacologic
rescue treatment regimens compared to IV amisulpride. There will be no predefined hypothesis
regarding the magnitude of efficacy or safety of various treatment regimens from the cohorts
observed. We are not proposing to directly recruit patients into this study.
Description:
Deidentified Electronic Health Record (EHR) information related to treatment of Post
Operative Nausea and Vomiting (PONV) will be collected from academic and community hospitals
throughout the United States. Deidentified EHRs for patients receiving treatment for PONV
will be harvested in two cohorts:
Cohort 1, Rescue treatment according to the standard of care (SOC) at each study site prior
to the introduction of IV amisulpride into clinical practice
Cohort 2, Rescue treatment IV amisulpride.
There is no planned investigational agent, prescribed treatment regimen, or mandated
intervention, and treating clinicians will determine therapy for PONV according to clinical
judgment. The projected inclusion over the course of this observational study is to enroll a
total of 20,000+ patient EHRs evenly divided among those that received SOC and amisulpride
treatment. Effectiveness and safety outcomes will be analyzed using standard statistical
methods for observational studies. Comparison of deidentified patient EHRs in Cohort 1 and
Cohort 2, including response rates, will be compiled and analyzed by an independent medical
data analytics company.
In regard to a Quality Assurance (QA) Plan that addresses data validation and registry
procedures, including any plans for site monitoring and auditing, ArborMetrix performs QA as
part of regular business. QA involves both automation testing and manual testing strategies
including Failure Mode and Effects Analysis (FMEA), bounds testing and exploratory testing.
Monitoring and auditing is done in line with their continued work toward HITRUST Compliance.
Regarding data checks to compare data entered into the registry against predefined rules for
range or consistency with other data fields in the registry, data validation is built into
the registry configuration based on predefined rules as part of the data analytics and
measures development. When receiving data in a batch, legal values, legal relationships,
primary keys, constraints, duplicates, range, format, length, data type, parent-child
relationship, variable name are all checked at both import and staging. The analytic process
checks naming, ticket #, unit test (Statistical Analysis System (SAS), Structure Query
Language (SQL)), integration, rules, range, consistency, outliers, missing and distribution.
As part of the Risk and Reliability (RR) Adjustment, ArborMetrix checks missing, unique
values, Observed to Expected (OE) ratio, C-stats, R squared and adjusted R squared. Report
validation in the UI (User Interface), which in this case means the registry platform,
compares reporting dictionary to analytic definition.
Regarding source data verification and assessing the accuracy, completeness, or
representativeness of registry data, data for PROMPT is being pulled directly from the EMR
system (i.e., external data sources) into the registry. No source data verification will be
conducted.
Regarding Standard Operating Procedures to address registry operations and analysis
activities, such as patient recruitment, data collection, data management, data analysis,
reporting for adverse events, and change management - there is no patient recruitment for
PROMPT. It is an observational study. Information on data collection/management/analysis is
answered in other questions. The change management system involves a Change Management Board,
Change Management Request form outlining event spurring the change, requested date/time,
engineers assigned, devices and/or systems being changed, a description of the change
including technical details, impact, risk validation method and backout plan. The Request is
peer reviewed and approved by leadership and technical personnel prior to implementation.
Plan for missing data to address situations where variables are reported as missing,
unavailable, non-reported, uninterpretable, or considered missing because of data
inconsistency or out-of-range results - As part of the data integration process, if variables
necessary to meet measure criteria are deemed not available, Acacia will determine the next
steps (i.e., remove measure, change measure criteria, etc.).
