Clinical trial NCT04235712: Implementation of Harmonized Depression Outcome Measures in a Health System
Official title: Implementation of Harmonized Depression Outcome Measures in a Health System to Support Patient-Centered Outcomes Research
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depression
Dysthymia
Lead sponsor: OM1, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2020-01-22
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Death from suicide
timeFrame: 12-month intervals
measure: Improvement in Depressive Symptoms: Remission
timeFrame: Baseline
measure: Improvement in Depressive Symptoms: Remission
timeFrame: 6 months post baseline (+/- 60 days)
measure: Improvement in Depressive Symptoms: Remission
timeFrame: 12 months post baseline (+/- 60 days)
measure: Improvement in Depressive Symptoms: Response
timeFrame: Baseline
measure: Improvement in Depressive Symptoms: Response
timeFrame: 6 months post baseline (+/- 60 days)
measure: Improvement in Depressive Symptoms: Response
timeFrame: 12 months post baseline (+/- 60 days)
measure: Worsening in Depressive Symptoms: Recurrence
timeFrame: Baseline
measure: Worsening in Depressive Symptoms: Recurrence
timeFrame: 6 months post baseline (+/- 60 days)
measure: Worsening in Depressive Symptoms: Recurrence
timeFrame: 12 months post baseline (+/- 60 days)
measure: Adverse Events
timeFrame: Baseline
measure: Adverse Events
timeFrame: 6 months post baseline (+/- 60 days)
measure: Adverse Events
timeFrame: 12 months post baseline (+/- 60 days)
measure: Suicide Ideation and Behavior
timeFrame: Baseline
measure: Suicide Ideation and Behavior
timeFrame: 6 months post baseline (+/- 60 days)
measure: Suicide Ideation and Behavior
timeFrame: 12 months post baseline (+/- 60 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Baystate Health
state: Massachusetts
Study officials:
References: