Implementation of Harmonized Depression Outcome Measures in a Primary Care Registry and a Mental Health Registry to Support Patient-Centered Outcomes Research
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- OM1, Inc.
- 入组人数
- 953
- 试验地点
- 2
- 主要终点
- Improvement in Depressive Symptoms: Response
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >=18 years
- •Diagnosis of major depression or dysthymia as documented in the patient's EMR
排除标准
- •There are no exclusion criteria for this study.
结局指标
主要结局
Improvement in Depressive Symptoms: Response
时间窗: 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.
Worsening in Depressive Symptoms: Recurrence
时间窗: 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.
Death from suicide
时间窗: 12-month intervals
Patient age 18 or older with a diagnosis of major depression or dysthymia who died from suicide.
Improvement in Depressive Symptoms: Remission
时间窗: 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.
Adverse Events
时间窗: 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 EMR. The Frequency, Intensity, and Burden of Side Effects Ratings score ranges from 0 to 6.
Suicide Ideation and Behavior and Behavior
时间窗: 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.
次要结局
未报告次要终点