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

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.

Study Overview

• Status: Completed
• Conditions: Major Depression; Dysthymia
• Intervention / Treatment: Other: Harmonized Depression Outcome Measures

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.

• Study Type: Observational
• Enrollment (Actual): 953

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20024
      • American Psychiatric Association
  • Kentucky
    • Lexington, Kentucky, United States, 40511
      • American Board of Family Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death from suicide	Patient age 18 or older with a diagnosis of major depression or dysthymia who died from suicide.	12-month intervals
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
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)
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)
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
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)
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)
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
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)
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)
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
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)
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)
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
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)
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)

Collaborators and Investigators

• Sponsor: OM1, Inc.
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2020
• Primary Completion (Actual): May 15, 2021
• Study Completion (Actual): May 15, 2021

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 16, 2020
• First Posted (Actual): January 22, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2021
• Last Update Submitted That Met QC Criteria: May 14, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Dysthymic Disorder
• Other Study ID Numbers: AHRQ_DEP_Registry

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No