Development and Validation of the Automated Evaluation of Gastrointestinal Symptoms (AEGIS) Platform

Sponsor

Cedars-Sinai Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02436057

Collaborator

National Institutes of Health (NIH) (NIH), University of California, Los Angeles (Other), VA Medical Center-West Los Angeles (U.S. Fed), University of Michigan (Other), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)

255

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Pain Deglutition Disorders Fecal Incontinence Nausea Diarrhea Constipation Gastroesophageal Reflux	Other: AEGIS (Automated Evaluation of Gastrointestinal Symptoms)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

255 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Development and Validation of the Automated Evaluation of Gastrointestinal Symptoms (AEGIS) Platform

Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual care Individuals in this arm will undergo usual care with their physician.
Experimental: AEGIS (Automated Evaluation of Gastrointestinal Symptoms) Individuals 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.	Other: AEGIS (Automated Evaluation of Gastrointestinal Symptoms)

Arm

Intervention/Treatment

No Intervention: Usual care

Individuals in this arm will undergo usual care with their physician.

Experimental: AEGIS (Automated Evaluation of Gastrointestinal Symptoms)

Individuals 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.

Other: AEGIS (Automated Evaluation of Gastrointestinal Symptoms)

Outcome Measures

Primary Outcome Measures

Patient satisfaction [CG-CAHPS completed within 2 months of their clinic visit]
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.

Secondary Outcome Measures

Patient Assessment of Physician Interpersonal Skills [DISQ completed within 2 months of their clinic visit]
The Doctors' Interpersonal Skills Questionnaire (DISQ) will be used to assess patient assessment of physician interpersonal skills.
Patient Assessment of Shared Decision Making [SDM-Q-9 completed within 2 months of their clinic visit]
The 9-item Shared Decision Making Questionnaire (SDM-Q-9) will be used to assess patient assessment of shared decision making.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
2	West Los Angeles VA Medical Center	Los Angeles	California	United States	90073
3	University of Michigan	Ann Arbor	Michigan	United States	48109