NCT04235712

Implementation of Harmonized Depression Outcome Measures in a Health System

Implementation of Harmonized Depression Outcome Measures in a Health System to Support Patient-Centered Outcomes Research

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5 (actual)
• Sponsor: OM1, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Working with a health system, the investigators will recruit practices to participate in the pilot study, consent and enroll patients with major depressive disorder, and collect the PHQ-9 from those patients at three timepoints (baseline, 6 months post-enrollment, and 12 months post-enrollment). The PHQ-9 will be captured either at an office visit or directly from patients. The investigators will build and implement an open-source SMART on FHIR app to collect key data from the EHR, combine that data with the PHQ-9 results, and present the measurements back to the clinicians. The investigators will then obtain feedback from clinicians on the value and usefulness of the app.

Detailed description

The study is a longitudinal, observational pilot study that will assess the utility and value displaying the harmonized outcomes data to clinicians in the clinical workflow using an open-source, SMART on FHIR app. The app will connect with the site EHR, aggregate EHR and PRO data, calculate the outcome measure results, and return the results to the EHR so that they are viewable within the clinician workflow. Baseline data on patient characteristics, treatments, and symptoms will be combined with longitudinal data on outcomes during the study timeframe. All data will be collected from institution electronic medical records (EMRs), PRO portals, and other existing data sources, as needed.

Conditions

• Major Depression
• Dysthymia

Interventions

Type	Name	Description
OTHER	Harmonized Depression Outcome Measures	This is an observational study where outcome measures will be extracted from patients' medical records and from questionnaires to provide information back to the clinician.

Timeline

• Start date: 2020-11-17
• Primary completion: 2021-05-15
• Completion: 2021-05-15
• First posted: 2020-01-22
• Last updated: 2021-05-18

Locations

1 site across 1 country: United States