- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05144230
Healthy Data: Improving Health Information Quality Using Intelligent Systems
December 6, 2021 updated by: Obinwa Ozonze, University of Portsmouth
Collection of Electronic Health Records (EHR) for Validation of Artificial Intelligence Based Tool for Data Quality Assessment
Electronic Health Record Systems (EHR) play an integral role in healthcare practice, enabling health organisations to collect, access and manage data more consistently.
There is also a great deal of interest in using EHR data to improve decision-making and accelerate medical interventions.
However, like all information systems, they are prone to data quality problems such as incomplete records, values outside normal ranges and implausible relationships.
These problems are expected to become more prevalent as more organisations adopt electronic health record systems, aggregate, share and explore health data.
The investigators believe current efforts to improve health data quality can be made more effective if backed by appropriate technology in the form of a readily accessible intelligent tool.
Building on this, the investigators developed an Artificial Intelligence (AI) tool for automating data quality assessment of health data.
In this study, the investigators evaluate the AI tool using a real-world dataset.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
The main aim of this study is to assess the reliability and utility of an AI tool in identifying data quality dimensions of interest for secondary use of health data, including completeness, conformance and plausibility.
In assessing this tool, this study will retrospectively analyse data captured during routine clinical care and identify records containing listed data quality dimensions.
This study will also assess the consistency of the AI tool in generating and executing data quality checks.
Study Type
Observational
Enrollment (Anticipated)
60000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Obinwa Ozonze, MSc
- Phone Number: 07391566946
- Email: obinwa.ozonze@port.ac.uk
Study Contact Backup
- Name: Adrian Hopgood, PhD
- Phone Number: 02392842946
- Email: adrian.hopgood@port.ac.uk
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patient records captured by Portsmouth Hospitals University National Health Service Trust (PHU) between 01/01/2020 and 31/12/2020
Description
Inclusion Criteria:
- No specific exclusion criteria
Exclusion Criteria:
- No specific exclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Data quality dimensions prevalence
Time Frame: 12 months, between 01/01/2020 and 31/12/2020
|
The number of patient records identified by the AI tool with completeness, conformance and plausibility violations
|
12 months, between 01/01/2020 and 31/12/2020
|
Consistency of AI tool
Time Frame: 2 months, through study completion
|
Consistency of AI tool in generating measures for detecting data quality dimensions
|
2 months, through study completion
|
Validity of AI tool detection
Time Frame: 2 months, through study completion
|
Validity of data quality dimensions identified by the AI tool
|
2 months, through study completion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 1, 2022
Primary Completion (Anticipated)
April 1, 2022
Study Completion (Anticipated)
April 1, 2022
Study Registration Dates
First Submitted
November 21, 2021
First Submitted That Met QC Criteria
November 21, 2021
First Posted (Actual)
December 3, 2021
Study Record Updates
Last Update Posted (Actual)
December 22, 2021
Last Update Submitted That Met QC Criteria
December 6, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- UP717295
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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