Clinical trial NCT02436057: Development and Validation of the Automated Evaluation of Gastrointestinal Symptoms (AEGIS) Platform
Official title: Development and Validation of the Automated Evaluation of Gastrointestinal Symptoms (AEGIS) Platform
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Pain
Deglutition Disorders
Fecal Incontinence
Nausea
Diarrhea
Constipation
Gastroesophageal Reflux
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: University of California, Los Angeles
name: VA Medical Center-West Los Angeles
name: University of Michigan
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2015-05-06
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

* Presenting to the gastrointestinal clinic for evaluation.
* Able to read and write English.
* Has basic computing skills.

Exclusion Criteria:

* Having been seen and evaluated in the gastrointestinal clinic within the last 8 months.

Primary outcomes:
measure: Patient satisfaction
timeFrame: CG-CAHPS completed within 2 months of their clinic visit
Secondary outcomes:
measure: Patient Assessment of Physician Interpersonal Skills
timeFrame: DISQ completed within 2 months of their clinic visit
measure: Patient Assessment of Shared Decision Making
timeFrame: SDM-Q-9 completed within 2 months of their clinic visit
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: West Los Angeles VA Medical Center
state: California
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References: