Implementation of Harmonized Depression Outcome Measures in a Health System

Implementation of Harmonized Depression Outcome Measures in a Health System to Support Patient-Centered Outcomes Research

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.

Study Overview

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

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Baystate Health

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 50 patients with a diagnosis of major depression or dysthymia from a total of five practices within the same health system.

Description

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.

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, reported in 12-month intervals.	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. A higher score means more severe depression.	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. A higher score means more severe depression.	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. A higher score means more severe depression.	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. A higher score means more severe depression.	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. A higher score means more severe depression.	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. A higher score means more severe depression.	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. A higher score means more severe depression.	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. A higher score means more severe depression.	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. A higher score means more severe depression.	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 Electronic Medical Record. The Frequency, Intensity, and Burden of Side Effects Ratings score ranges from 0 to 6. A higher score means more of a burden.	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 Electronic Medical Record. The Frequency, Intensity, and Burden of Side Effects Ratings score ranges from 0 to 6. A higher score means more of a burden.	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 Electronic Medical Record. The Frequency, Intensity, and Burden of Side Effects Ratings score ranges from 0 to 6. A higher score means more of a burden.	12 months post baseline (+/- 60 days)
Suicide Ideation 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. A higher score means more severe depression.	Baseline
Suicide Ideation 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. A higher score means more severe depression.	6 months post baseline (+/- 60 days)
Suicide Ideation 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. A higher score means more severe depression.	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): November 17, 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 17, 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_Health_System

Drug and device information, study documents

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