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

NCT ID: NCT02530216

Last Updated: 2018-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 610 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-10
• Study Completion Date: 2018-02-07

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Usual care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

AEGIS (Automated Evaluation of Gastrointestinal Symptoms)

Intervention Type: OTHER

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."

Interventions

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."

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Christopher Almario

Staff Physician and Health Services Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

Pro00045243

Identifier Type: -

Identifier Source: org_study_id