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Trial record 11 of 200 for:    gastroenterology | Recruiting Studies | United States

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

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ClinicalTrials.gov Identifier: NCT02530216
Recruitment Status : Recruiting
First Posted : August 20, 2015
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Christopher Almario, Cedars-Sinai Medical Center

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.


Condition or disease Intervention/treatment
Abdominal Pain Deglutition Disorders Fecal Incontinence Nausea Diarrhea Constipation Gastroesophageal Reflux Other: AEGIS (Automated Evaluation of Gastrointestinal Symptoms)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 448 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Automated Evaluation of Gastrointestinal Symptoms (AEGIS): A Pragmatic Clinical Trial Evaluating the Impact of AEGIS on Clinical Outcomes
Actual Study Start Date : April 10, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

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)
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 Measures :
  1. Prevalence of documented alarm symptoms [ Time Frame: Completed and documented by the physician in the clinic note within 1 week of the initial clinic visit ]
    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 :
  1. 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 ]
  2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530216


Contacts
Contact: Christopher V Almario, MD, MSHPM 310-423-4462 christopher.almario@cshs.org

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Christopher V Almario, MD, MSHPM    310-423-4462    christopher.almario@cshs.org   
Sponsors and Collaborators
Cedars-Sinai Medical Center

Responsible Party: Christopher Almario, Staff Physician and Health Services Research Scientist, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02530216     History of Changes
Other Study ID Numbers: Pro00045243
First Posted: August 20, 2015    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018

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

Additional relevant MeSH terms:
Constipation
Diarrhea
Gastroesophageal Reflux
Abdominal Pain
Fecal Incontinence
Deglutition Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Esophageal Motility Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Rectal Diseases
Intestinal Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases