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

Primary Purpose

Abdominal Pain, Deglutition Disorders, Fecal Incontinence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AEGIS (Automated Evaluation of Gastrointestinal Symptoms)
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Abdominal Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cedars-Sinai Medical Center
  • West Los Angeles VA Medical Center
  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

AEGIS (Automated Evaluation of Gastrointestinal Symptoms)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patient Assessment of Physician Interpersonal Skills
The Doctors' Interpersonal Skills Questionnaire (DISQ) will be used to assess patient assessment of physician interpersonal skills.
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.

Full Information

First Posted
May 1, 2015
Last Updated
January 13, 2016
Sponsor
Cedars-Sinai Medical Center
Collaborators
National Institutes of Health (NIH), University of California, Los Angeles, VA Medical Center-West Los Angeles, University of Michigan, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT02436057
Brief Title
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

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
Collaborators
National Institutes of Health (NIH), University of California, Los Angeles, VA Medical Center-West Los Angeles, University of Michigan, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain, Deglutition Disorders, Fecal Incontinence, Nausea, Diarrhea, Constipation, Gastroesophageal Reflux

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
255 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Individuals in this arm will undergo usual care with their physician.
Arm Title
AEGIS (Automated Evaluation of Gastrointestinal Symptoms)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
AEGIS (Automated Evaluation of Gastrointestinal Symptoms)
Primary Outcome Measure Information:
Title
Patient satisfaction
Description
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.
Time Frame
CG-CAHPS completed within 2 months of their clinic visit
Secondary Outcome Measure Information:
Title
Patient Assessment of Physician Interpersonal Skills
Description
The Doctors' Interpersonal Skills Questionnaire (DISQ) will be used to assess patient assessment of physician interpersonal skills.
Time Frame
DISQ completed within 2 months of their clinic visit
Title
Patient Assessment of Shared Decision Making
Description
The 9-item Shared Decision Making Questionnaire (SDM-Q-9) will be used to assess patient assessment of shared decision making.
Time Frame
SDM-Q-9 completed within 2 months of their clinic visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
West Los Angeles VA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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