Clinical trial NCT04235725: Implementation of Harmonized Depression Outcome Measures in a Primary Care Registry and a Mental Health Registry
Official title: Implementation of Harmonized Depression Outcome Measures in a Primary Care Registry and a Mental Health Registry to Support Patient-Centered Outcomes Research
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depression
Dysthymia
Lead sponsor: OM1, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2020-01-22
Enrollment: 953
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will collect data on approximately 200 patients with a diagnosis of major depression or dysthymia from a total of 20 sites (10 from each registry).

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age \>=18 years
* Diagnosis of major depression or dysthymia as documented in the patient's EMR

Exclusion Criteria:

* There are no exclusion criteria for this study.

Primary outcomes:
measure: Death from suicide
timeFrame: 12-month intervals
measure: Improvement in Depressive Symptoms: Remission
timeFrame: Baseline
measure: Improvement in Depressive Symptoms: Remission
timeFrame: 6 months post baseline (+/- 60 days)
measure: Improvement in Depressive Symptoms: Remission
timeFrame: 12 months post baseline (+/- 60 days)
measure: Improvement in Depressive Symptoms: Response
timeFrame: Baseline
measure: Improvement in Depressive Symptoms: Response
timeFrame: 6 months post baseline (+/- 60 days)
measure: Improvement in Depressive Symptoms: Response
timeFrame: 12 months post baseline (+/- 60 days)
measure: Worsening in Depressive Symptoms: Recurrence
timeFrame: Baseline
measure: Worsening in Depressive Symptoms: Recurrence
timeFrame: 6 months post baseline (+/- 60 days)
measure: Worsening in Depressive Symptoms: Recurrence
timeFrame: 12 months post baseline (+/- 60 days)
measure: Adverse Events
timeFrame: Baseline
measure: Adverse Events
timeFrame: 6 months post baseline (+/- 60 days)
measure: Adverse Events
timeFrame: 12 months post baseline (+/- 60 days)
measure: Suicide Ideation and Behavior and Behavior
timeFrame: Baseline
measure: Suicide Ideation and Behavior and Behavior
timeFrame: 6 months post baseline (+/- 60 days)
measure: Suicide Ideation and Behavior and Behavior
timeFrame: 12 months post baseline (+/- 60 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: American Psychiatric Association
state: District of Columbia
city: Lexington
country: United States
facility: American Board of Family Medicine
state: Kentucky
Study officials:
References: