Implementation of Harmonized Depression Outcome Measures in a Health System

Major Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04235712
• Other study ID #: AHRQ_DEP_Health_System
• Status: Completed
• Start date: November 17, 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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• 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:

• 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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Dysthymia
• Major Depression

Intervention

Other:
• Harmonized Depression Outcome Measures
This is an observational study where outcome measures will be extracted from patients' medical records and from questionnaires to provide information back to the clinician.

Locations

Country	Name	City	State
United States	Baystate Health	Springfield	Massachusetts

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, reported in 12-month intervals.	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. A higher score means more severe depression.	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. A higher score means more severe depression.	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. A higher score means more severe depression.	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. A higher score means more severe depression.	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. A higher score means more severe depression.	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. A higher score means more severe depression.	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. A higher score means more severe depression.	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. A higher score means more severe depression.	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. A higher score means more severe depression.	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 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
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 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)
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 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)
Primary	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
Primary	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)
Primary	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)

External Links

•   AHRQ webpage containing details on this initiative