Ignite Creation Date:
2024-05-06 @ 4:02 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02436057
Status:
COMPLETED
Last Update Posted:
2016-01-15
First Post:
2015-05-01
Brief Title:
Development and Validation of the Automated Evaluation of Gastrointestinal Symptoms AEGIS Platform
Sponsor:
Cedars-Sinai Medical Center
Organization:
Cedars-Sinai Medical Center
Study Overview
Official Title:
Development and Validation of the Automated Evaluation of Gastrointestinal Symptoms AEGIS Platform
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Through a four-year grant awarded to the University of California at Los Angeles in 2009 Dr Brennan Spiegel served as a principal investigator PI for a project to develop and initially validate a bank of items to assess gastrointestinal GI symptoms for the National Institutes of Healths NIHs Patient Reported Outcomes Measurement Information System PROMIS By the end of the grant period in July 2013 the project team had successfully developed and initially validated eight scales measuring the most common GI symptoms
Afterwards Dr Spiegels PROMIS team joined forces with the UCLA Computing Technology Research Laboratory CTRL and the University of Michigan Center for Healthcare Communication Research to develop the Automated Evaluation of Gastrointestinal Symptoms AEGIS algorithm which is delivered via My GI Health an open--source Internet based patient-provider portal P3 designed to enhance the delivery of GI health care wwwMyGIHealthorg Through My GI Health and AEGIS patients are able to complete PROMIS GI symptom measures and provide additional information about their GI symptoms and histories from computers tablets or smart phones without the constraints of physical locale This information is condensed into a GI PROMIS scores report and initial GI history that patients providers can review prior to or concurrent with seeing the patient The report which can be incorporated into the electronic health record EHR helps busy clinicians to quickly understand the patients complaints document their symptoms and GI history and leaves more time for conversation with the patient
Beyond focusing their interaction My GI Health also supports both the clinician and patient with an individualized educational prescription which guides the patient through a library of multi-media educational materials on GI symptoms conditions and treatments also contained within the website The prescription is initially created by the website based on each patients unique GI PROMIS fingerprint and can be modified by the provider based on their interaction with the patient The clinician and patient can also access the PROMIS-tailored education in the exam room to jointly review pertinent materials including animations of normal and abnormal GI functions further reinforcing the patients educational experiences around the PROMIS symptoms
The aim of this current study is to validate the use of GI PROMIS in clinical practice by conducting a pragmatic clinical trial PCT comparing delivery of GI PROMIS on a novel e--platform vs usual care
Afterwards Dr Spiegels PROMIS team joined forces with the UCLA Computing Technology Research Laboratory CTRL and the University of Michigan Center for Healthcare Communication Research to develop the Automated Evaluation of Gastrointestinal Symptoms AEGIS algorithm which is delivered via My GI Health an open--source Internet based patient-provider portal P3 designed to enhance the delivery of GI health care wwwMyGIHealthorg Through My GI Health and AEGIS patients are able to complete PROMIS GI symptom measures and provide additional information about their GI symptoms and histories from computers tablets or smart phones without the constraints of physical locale This information is condensed into a GI PROMIS scores report and initial GI history that patients providers can review prior to or concurrent with seeing the patient The report which can be incorporated into the electronic health record EHR helps busy clinicians to quickly understand the patients complaints document their symptoms and GI history and leaves more time for conversation with the patient
Beyond focusing their interaction My GI Health also supports both the clinician and patient with an individualized educational prescription which guides the patient through a library of multi-media educational materials on GI symptoms conditions and treatments also contained within the website The prescription is initially created by the website based on each patients unique GI PROMIS fingerprint and can be modified by the provider based on their interaction with the patient The clinician and patient can also access the PROMIS-tailored education in the exam room to jointly review pertinent materials including animations of normal and abnormal GI functions further reinforcing the patients educational experiences around the PROMIS symptoms
The aim of this current study is to validate the use of GI PROMIS in clinical practice by conducting a pragmatic clinical trial PCT comparing delivery of GI PROMIS on a novel e--platform vs usual care
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 7U01AR057936-05 | NIH | None | httpsreporternihgovquickSearch7U01AR057936-05 |