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Evaluating the Impact of Automated Evaluation of Gastrointestinal Symptoms (AEGIS) on Clinical Outcomes (AEGIS)

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

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

Prevalence of documented alarm symptoms
Prevalence of documented alarm symptoms (blood in the stool, unintentional weight loss, hematochezia, hematemesis) in the clinic note as documented by physicians.

Secondary Outcome Measures

Prevalence of diagnosed organic disease
Time to diagnosis of organic disease

Full Information

First Posted
August 19, 2015
Last Updated
April 29, 2018
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02530216
Brief Title
Evaluating the Impact of Automated Evaluation of Gastrointestinal Symptoms (AEGIS) on Clinical Outcomes
Acronym
AEGIS
Official Title
Automated Evaluation of Gastrointestinal Symptoms (AEGIS): A Pragmatic Clinical Trial Evaluating the Impact of AEGIS on Clinical Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 10, 2017 (Actual)
Primary Completion Date
February 7, 2018 (Actual)
Study Completion Date
February 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Healthcare delivery now mandates shorter visits with higher documentation requirements, undermining the patient-provider interaction. Electronic health records (EHRs) have the potential to improve outcomes and quality of care in this pressured environment, and are endorsed by the Patient Protection and Affordable Care Act (ACA) and Health Information Technology for Economic and Clinical Health (HITECH) Act as an important mechanism to support value-based healthcare. However, EHR systems were principally designed to support the transactional needs of administrators and billers, less so to nurture the relationship between patients and their providers. The purpose of this research is to identify ways to use EHRs to support clinical gastroenterologists and their patients while meeting the meaningful use requirements of the HITECH Act. To improve clinic visit efficiency and meet criteria for meaningful use, investigators developed a patient-provider portal (P3) that systematically collects patient symptoms using a computer algorithm called Automated Evaluation of Gastrointestinal Symptoms (AEGIS). AEGIS utilizes computerized adaptive testing (CAT) to guide patients through questions drawn from a library of over 300 symptom attributes measuring the timing, severity, frequency, location, quality, and character of their GI symptoms, along with relevant comorbidities, family history, and alarm features. The system then automatically "translates" the patient report into a full narrative HPI available for use by GI providers in an EHR. In a cross-sectional study in the American Journal of Gastroenterology comparing AEGIS versus physician-documented HPIs, investigators found that blinded physician reviewers perceived that AEGIS HPIs were of higher overall quality, better organized, and more succinct, comprehensible, complete and useful compared to HPIs written by physicians during usual care in academic GI clinics. In the current study, investigators aim to evaluate computer-generated HPIs prospectively on a wider scale in diverse academic and community-based settings. Moreover, investigators aim to test an enhanced AEGIS intervention that ties patient HPIs to an individualized "education prescription" which guides the patient through a library of multi-media educational materials on GI symptoms, conditions, and treatments.

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
610 (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)
Intervention Description
AEGIS (Automated Evaluation of Gastrointestinal Symptoms) guides patients through questionnaires to measure symptom attributes including the timing, severity, frequency, location, quality, and character of their gastrointestinal (GI) symptoms, along with relevant comorbidities, family history, and alarm features. This information is transformed into a history of present illness (HPI) written in language familiar to clinicians. AEGIS also supports both the clinician and patient with an individualized "education prescription" which guides the patient through a library of multi-media educational materials on GI symptoms, conditions, and treatments. The prescription is created by the portal based on each patient's unique AEGIS "fingerprint."
Primary Outcome Measure Information:
Title
Prevalence of documented alarm symptoms
Description
Prevalence of documented alarm symptoms (blood in the stool, unintentional weight loss, hematochezia, hematemesis) in the clinic note as documented by physicians.
Time Frame
Completed and documented by the physician in the clinic note within 1 week of the initial clinic visit
Secondary Outcome Measure Information:
Title
Prevalence of diagnosed organic disease
Time Frame
Organic disease (e.g., Celiac disease, inflammatory bowel disease, etc.) diagnosed within 6 months of the initial clinic visit
Title
Time to diagnosis of organic disease
Time Frame
Time to diagnosis of organic disease (e.g., Celiac disease, inflammatory bowel disease, etc.) within 6 months of the initial 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

12. IPD Sharing Statement

Learn more about this trial

Evaluating the Impact of Automated Evaluation of Gastrointestinal Symptoms (AEGIS) on Clinical Outcomes

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