NCT04235725

Implementation of Harmonized Depression Outcome Measures in a Primary Care Registry and a Mental Health Registry

Implementation of Harmonized Depression Outcome Measures in a Primary Care Registry and a Mental Health Registry to Support Patient-Centered Outcomes Research

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 953 (actual)
• Sponsor: OM1, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this pilot project is to demonstrate feasibility and value of collecting harmonized outcomes measures for major depressive disorder (MDD) in two registries and combining the data to support patient-centered outcomes research.

Detailed description

The study is a longitudinal, multi-center observational feasibility study that will include data on eligible patients with a diagnosis of major depressive disorder (MDD). Retrospective data on previous disease status and patient characteristics will be collected and combined with longitudinal data from these data sources 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. Two registries (PsychPRO and the PRIME Registry) will participate in this feasibility study. A total of 20 sites participating in the registries (10 from each registry) will be recruited to participate in this study. To participate, sites must see adult patients with major depression or dysthymia and be willing to collect the PHQ-9 on a regular basis. Sites will have the option of using the Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER) scale to capture information on adverse events, but use of the FIBSER is not required.

Conditions

• Major Depression
• Dysthymia

Interventions

Type	Name	Description
OTHER	Harmonized Depression Outcome Measures	This is an observational study where retrospective data on previous disease status and patient characteristics will be collected and combined with longitudinal data from these data sources on outcomes during the study timeframe.

Timeline

• Start date: 2020-03-15
• Primary completion: 2021-05-15
• Completion: 2021-05-15
• First posted: 2020-01-22
• Last updated: 2021-05-18

Locations

2 sites across 1 country: United States