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Completed

NCT Number: NCT02436057

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

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.

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Key information

Conditions

Abdominal Pain Constipation Deglutition Disorders Diarrhea Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Fecal Incontinence Gastroesophageal Reflux Gastrointestinal Diseases Intestinal Diseases Nausea Neurologic Manifestations Otorhinolaryngologic Diseases Pain Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Rectal Diseases Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AEGIS (Automated Evaluation of Gastrointestinal Symptoms)

Other

Primary outcomes

  1. Patient satisfaction

    Time frame: 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 outcomes

  1. Patient Assessment of Physician Interpersonal Skills

    Time frame: 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.

  2. Patient Assessment of Shared Decision Making

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Collaborators

  • 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

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 6, 2015
Registry last updated
Jan 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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