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

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02436057
• Other study ID #: 0023
• Secondary ID: 7U01AR057936-05
• Status: Completed
• Phase: N/A
• First received: May 1, 2015
• Last updated: January 13, 2016
• Start date: July 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Abdominal Pain
• Constipation
• Deglutition Disorders
• Diarrhea
• Fecal Incontinence
• Gastroesophageal Reflux
• Nausea

Intervention

Other:
• AEGIS (Automated Evaluation of Gastrointestinal Symptoms)

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	West Los Angeles VA Medical Center	Los Angeles	California

Sponsors (6)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), University of California, Los Angeles, University of Michigan, VA Medical Center-West Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Patient Assessment of Physician Interpersonal Skills	The Doctors' Interpersonal Skills Questionnaire (DISQ) will be used to assess patient assessment of physician interpersonal skills.	DISQ completed within 2 months of their clinic visit	No
Secondary	Patient Assessment of Shared Decision Making	The 9-item Shared Decision Making Questionnaire (SDM-Q-9) will be used to assess patient assessment of shared decision making.	SDM-Q-9 completed within 2 months of their clinic visit	No