Development and Validation of the Automated Evaluation of Gastrointestinal Symptoms (AEGIS) Platform
2 other identifiers
interventional
255
1 country
3
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 Health's (NIH's) 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. Spiegel's 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 (www.MyGIHealth.org). 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 patient's 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 patient's 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2014
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 1, 2015
CompletedFirst Posted
Study publicly available on registry
May 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJanuary 15, 2016
January 1, 2016
1.4 years
May 1, 2015
January 13, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Patient satisfaction
The Consumer Assessment of Health Providers \& Systems Clinician and Group Survey - Adult Visit Questionnaire 2.0 (CG-CAHPS) will be used to assess patient satisfaction.
CG-CAHPS completed within 2 months of their clinic visit
Secondary Outcomes (2)
Patient Assessment of Physician Interpersonal Skills
DISQ completed within 2 months of their clinic visit
Patient Assessment of Shared Decision Making
SDM-Q-9 completed within 2 months of their clinic visit
Study Arms (2)
Usual care
NO INTERVENTIONIndividuals in this arm will undergo usual care with their physician.
AEGIS (Automated Evaluation of Gastrointestinal Symptoms)
EXPERIMENTALIndividuals in the AEGIS arm will be invited to use AEGIS/My GI Health prior to their clinic visit. For those who complete AEGIS/My GI Health, their physician will have access to their AEGIS symptom report (includes a GI symptom heat map and GI history) and tailored education prescription.
Interventions
Eligibility Criteria
You may qualify if:
- Presenting to the gastrointestinal clinic for evaluation.
- Able to read and write English.
- Has basic computing skills.
You may not qualify if:
- Having been seen and evaluated in the gastrointestinal clinic within the last 8 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cedars-Sinai Medical Centerlead
- National Institutes of Health (NIH)collaborator
- University of California, Los Angelescollaborator
- VA Medical Center-West Los Angelescollaborator
- University of Michigancollaborator
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)collaborator
Study Sites (3)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
West Los Angeles VA Medical Center
Los Angeles, California, 90073, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor-in-Residence of Medicine and Public Health
Study Record Dates
First Submitted
May 1, 2015
First Posted
May 6, 2015
Study Start
July 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
January 15, 2016
Record last verified: 2016-01