Major DepressionNCT04235712
Implementation of Harmonized Depression Outcome Measures in a Health System
An observational study of Major Depression and Dysthymia, run by OM1, Inc. at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depression, Dysthymia
- What is being tested?
- Harmonized Depression Outcome Measures
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2020to 15 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients age 18 and older
- Diagnosis of major depression or dysthymia
- Willing and able to provide informed consent
Who cannot join
- There are no exclusion criteria for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Major Depression, Dysthymia
- Being tested
- Harmonized Depression Outcome Measures
- Medical subject headings
- Depressive Disorder, Major, Dysthymic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harmonized Depression Outcome MeasuresOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months post baseline (+/- 60 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start17 Nov 2020
- Primary completion15 May 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- OM1, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235712
- Sponsor's protocol ID
- AHRQ_DEP_Health_System
- Status last verified
- May 2021
- First submitted
- 7 Jan 2020
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Harmonized Depression Outcome Measures in a Health System to Support Patient-Centered Outcomes Research
- ClinicalTrials.gov ID
- NCT04235712
- Acronym / sponsor ID
- AHRQ_DEP_Health_System
- Conditions
- Major Depression, Dysthymia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- OM1, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients age 18 and older
- Diagnosis of major depression or dysthymia
- Willing and able to provide informed consent
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Harmonized Depression Outcome MeasuresThis is an observational study where outcome measures will be extracted from patients' medical records and from questionnaires to provide information back to the clinician. | Other | – |
Primary outcome
Death from suicide
Time frame: 12-month intervals
Patient age 18 or older with a diagnosis of major depression or dysthymia who died from suicide, reported in 12-month intervals.
Improvement in Depressive Symptoms: Remission
Time frame: Baseline
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.
Improvement in Depressive Symptoms: Remission
Time frame: 6 months post baseline (+/- 60 days)
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.
Improvement in Depressive Symptoms: Remission
Time frame: 12 months post baseline (+/- 60 days)
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.
Improvement in Depressive Symptoms: Response
Time frame: Baseline
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.
Improvement in Depressive Symptoms: Response
Time frame: 6 months post baseline (+/- 60 days)
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.
Improvement in Depressive Symptoms: Response
Time frame: 12 months post baseline (+/- 60 days)
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.
Worsening in Depressive Symptoms: Recurrence
Time frame: Baseline
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.
Worsening in Depressive Symptoms: Recurrence
Time frame: 6 months post baseline (+/- 60 days)
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.
Worsening in Depressive Symptoms: Recurrence
Time frame: 12 months post baseline (+/- 60 days)
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.
Adverse Events
Time frame: Baseline
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.
Adverse Events
Time frame: 6 months post baseline (+/- 60 days)
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.
Adverse Events
Time frame: 12 months post baseline (+/- 60 days)
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.
Suicide Ideation and Behavior
Time frame: Baseline
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.
Suicide Ideation and Behavior
Time frame: 6 months post baseline (+/- 60 days)
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.
Suicide Ideation and Behavior
Time frame: 12 months post baseline (+/- 60 days)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- AHRQ webpage containing details on this initiativeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depression and Dysthymia, run by OM1, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death from suicide (time frame: 12-month intervals). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.