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

Major Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04235725
• Other study ID #: AHRQ_DEP_Registry
• Status: Completed
• Start date: March 15, 2020
• Est. completion date: May 15, 2021

Study information

• Verified date: May 2021
• Source: OM1, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 953
• Est. completion date: May 15, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Dysthymia
• Major Depression

Intervention

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.

Locations

Country	Name	City	State
United States	American Board of Family Medicine	Lexington	Kentucky
United States	American Psychiatric Association	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
OM1, Inc.	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death from suicide	Patient age 18 or older with a diagnosis of major depression or dysthymia who died from suicide.	12-month intervals
Primary	Improvement in Depressive Symptoms: Remission	Patient Health Questionnaire-9 score > 9 who demonstrates remission defined as a Patient Health Questionnaire-9 score less than 5. Patient Health Questionnaire scores range from 0 to 27.	Baseline
Primary	Improvement in Depressive Symptoms: Remission	Patient Health Questionnaire-9 score > 9 who demonstrates remission defined as a Patient Health Questionnaire-9 score less than 5. Patient Health Questionnaire scores range from 0 to 27.	6 months post baseline (+/- 60 days)
Primary	Improvement in Depressive Symptoms: Remission	Patient Health Questionnaire-9 score > 9 who demonstrates remission defined as a Patient Health Questionnaire-9 score less than 5. Patient Health Questionnaire scores range from 0 to 27.	12 months post baseline (+/- 60 days)
Primary	Improvement in Depressive Symptoms: Response	Patient age 18 or older with a diagnosis of major depression or dysthymia and an initial Patient Health Questionnaire-9 score > 9 who demonstrates a response to treatment defined as a Patient Health Questionnaire-9 score that is reduced by 50% or greater from the initial Patient Health Questionnaire-9 score. Patient Health Questionnaire scores range from 0 to 27.	Baseline
Primary	Improvement in Depressive Symptoms: Response	Patient age 18 or older with a diagnosis of major depression or dysthymia and an initial Patient Health Questionnaire-9 score > 9 who demonstrates a response to treatment defined as a Patient Health Questionnaire-9 score that is reduced by 50% or greater from the initial Patient Health Questionnaire-9 score. Patient Health Questionnaire scores range from 0 to 27.	6 months post baseline (+/- 60 days)
Primary	Improvement in Depressive Symptoms: Response	Patient age 18 or older with a diagnosis of major depression or dysthymia and an initial Patient Health Questionnaire-9 score > 9 who demonstrates a response to treatment defined as a Patient Health Questionnaire-9 score that is reduced by 50% or greater from the initial Patient Health Questionnaire-9 score. Patient Health Questionnaire scores range from 0 to 27.	12 months post baseline (+/- 60 days)
Primary	Worsening in Depressive Symptoms: Recurrence	Patient age 18 or older with a diagnosis of major depression or dysthymia and an initial Patient Health Questionnaire-9 > 9 who demonstrates remission (defined as a Patient Health Questionnaire-9 score < 5) of at least two months' duration and subsequently experiences a recurrence of a depressive episode, defined as a Patient Health Questionnaire-9 score > 9 OR hospitalization for depression or suicidality. Patient Health Questionnaire scores range from 0 to 27.	Baseline
Primary	Worsening in Depressive Symptoms: Recurrence	Patient age 18 or older with a diagnosis of major depression or dysthymia and an initial Patient Health Questionnaire-9 > 9 who demonstrates remission (defined as a Patient Health Questionnaire-9 score < 5) of at least two months' duration and subsequently experiences a recurrence of a depressive episode, defined as a Patient Health Questionnaire-9 score > 9 OR hospitalization for depression or suicidality. Patient Health Questionnaire scores range from 0 to 27.	6 months post baseline (+/- 60 days)
Primary	Worsening in Depressive Symptoms: Recurrence	Patient age 18 or older with a diagnosis of major depression or dysthymia and an initial Patient Health Questionnaire-9 > 9 who demonstrates remission (defined as a Patient Health Questionnaire-9 score < 5) of at least two months' duration and subsequently experiences a recurrence of a depressive episode, defined as a Patient Health Questionnaire-9 score > 9 OR hospitalization for depression or suicidality. Patient Health Questionnaire scores range from 0 to 27.	12 months post baseline (+/- 60 days)
Primary	Adverse Events	Depression treatment-related adverse events, captured using the Frequency, Intensity, and Burden of Side Effects Ratings scale where available and extracted from data routinely recorded in the EMR. The Frequency, Intensity, and Burden of Side Effects Ratings score ranges from 0 to 6.	Baseline
Primary	Adverse Events	Depression treatment-related adverse events, captured using the Frequency, Intensity, and Burden of Side Effects Ratings scale where available and extracted from data routinely recorded in the EMR. The Frequency, Intensity, and Burden of Side Effects Ratings score ranges from 0 to 6.	6 months post baseline (+/- 60 days)
Primary	Adverse Events	Depression treatment-related adverse events, captured using the Frequency, Intensity, and Burden of Side Effects Ratings scale where available and extracted from data routinely recorded in the EMR. The Frequency, Intensity, and Burden of Side Effects Ratings score ranges from 0 to 6.	12 months post baseline (+/- 60 days)
Primary	Suicide Ideation and Behavior and Behavior	Selection of 'several days', 'more than half the days' or 'nearly every day' option on Patient Health Questionnaire-9 item 9 ("Thoughts that you would be better off dead or of hurting yourself in some way") and/or documentation of nonfatal suicide attempts/suicide attempt behaviors, planning/preparatory acts, or active suicidal ideation extracted from data routinely recorded in the Electronic Medical Record.	Baseline
Primary	Suicide Ideation and Behavior and Behavior	Selection of 'several days', 'more than half the days' or 'nearly every day' option on Patient Health Questionnaire-9 item 9 ("Thoughts that you would be better off dead or of hurting yourself in some way") and/or documentation of nonfatal suicide attempts/suicide attempt behaviors, planning/preparatory acts, or active suicidal ideation extracted from data routinely recorded in the Electronic Medical Record.	6 months post baseline (+/- 60 days)
Primary	Suicide Ideation and Behavior and Behavior	Selection of 'several days', 'more than half the days' or 'nearly every day' option on Patient Health Questionnaire-9 item 9 ("Thoughts that you would be better off dead or of hurting yourself in some way") and/or documentation of nonfatal suicide attempts/suicide attempt behaviors, planning/preparatory acts, or active suicidal ideation extracted from data routinely recorded in the Electronic Medical Record.	12 months post baseline (+/- 60 days)

External Links

•   AHRQ webpage containing details on this initiative