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Implementation of Harmonized Depression Outcome Measures in a Health System

O

OM1

Status

Completed

Conditions

Major Depression
Dysthymia

Treatments

Other: Harmonized Depression Outcome Measures

Study type

Observational

Funder types

Industry
Other U.S. Federal agency

Identifiers

NCT04235712
AHRQ_DEP_Health_System

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients age 18 and older
  • Diagnosis of major depression or dysthymia
  • Willing and able to provide informed consent

Exclusion criteria

  • There are no exclusion criteria for this study.

Trial design

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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