跳至主要内容
临床试验/NCT02266134
NCT02266134已完成不适用

Standardized Versus Tailored Implementation of Measurement Based Care for Depression

Indiana University6 个研究点 分布在 1 个国家目标入组 382 人开始时间: 2015年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
382
试验地点
6
主要终点
Patient Health Questionnaire

研究概览

简要总结

Depression remains among the nation's top 10 chronic illnesses, costing over $80 billion annually; however, Measurement Based Care (MBC) is a relatively simple evidence-based intervention framework that has been shown to improve outcomes for depressed clients by identifying those who are not making progress and reducing the likelihood that clients will deteriorate in treatment. Despite the demonstrated effectiveness of MBC, the majority of community mental health counselors do not regularly assess target problem symptoms to guide their work. This study will test a standardized versus a tailored approach to implementing MBC that will include the integration of symptom monitoring capacities into the electronic health record system of one of the nation's largest not-for-profit providers of behavioral health services.

详细描述

Depression remains among the nation's top 10 chronic illnesses, costing over $80 billion annually. Depression has been called the "Common Cold" of mental illness, but one with serious risk of morbidity and mortality. There are now many evidence-based practices for the treatment of depression, but unfortunately these practices remain largely unavailable to clients receiving services in community mental health centers. Measurement Based Care (MBC) is a relatively simple evidence-based intervention framework. MBC, by definition, is the practice of using symptom measurement to inform mental health care. Physicians who routinely measure the patient's blood pressure when the treatment target is high blood pressure demonstrate the medical corollary of MBC. When MBC is used in the treatment of depressed adults, it has been shown to improve outcomes by identifying clients who are not making progress and reducing the likelihood that clients will deteriorate in treatment. However, despite the demonstrated effectiveness of MBC, the majority of community mental health counselors (i.e., clinicians) do not regularly assess target problem symptoms to guide their work over the course of treatment. To our knowledge, no studies to date have focused on the process of implementing MBC in community mental health settings. The long-term goal of this research project is to provide generalizable and practical recommendations about implementation approaches that promote MBC use and fidelity in community mental health centers. Specifically, this study will test a standardized versus a tailored approach to implementing MBC in one of the nation's largest not-for-profit providers of behavioral health services. Although touted as superior, tailored implementations have rarely been compared to standardized approaches. Moreover, recent research has demonstrated an apparent need to adapt evidence-based practices to fit the specific context in which they are being implemented, particularly if they are to be sustained. This proposal reflects a movement in the field of implementation science in which planned adaptations are being tested and compared to standardized versions. The proposed research is a three-phase, mixed methods (quantitative/qualitative) study to investigate the effect of these two different approaches to MBC implementation on both clinician-level (e.g., MBC fidelity) and client-level (depression symptom change) outcomes. We will focus on contextual factors (e.g., attitudes, resources, process, etc.) that may influence the implementation process with the goal of identifying a generalizable and practical way of bringing MBC to community mental health centers treating depressed adults.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

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

  • •To be included, Patients must:
  • •be age 18 or above at time of enrollment;
  • •have depression as one of their primary treatment foci based on diagnosis made by clinicians using usual care interview methods to reflect major depressive disorder, dysthymic disorder, depressive disorder NOS, adjustment disorder with depressed mood;
  • •have significant depressive symptom severity (PHQ-9 total score > 9);
  • •receive individual psychotherapy;
  • •be fluent in English; and
  • •receive therapy from an enrolled study clinician during the proposed funding period
  • •Patients will be excluded if they have an inability to sign the consent form (due to lack of competence or inability to read).
  • •Therapist Inclusion Criteria -- Therapists must:
  • •be a practicing clinician at Centerstone; and
  • •see at least one adult (18+) patient

排除标准

  • 未提供

研究组 & 干预措施

Standardized Implementation, Patients

Experimental

Sites in standardized condition arm will receive the standard implementation of measurement-based care intervention (PHQ-9).

干预措施: Standard Implementation of Measurement Based Care (Behavioral)

Tailored Implementation, Patients

Experimental

Sites in the tailored condition arm will receive the tailored implementation of measurement-based care intervention (PHQ-9).

干预措施: Tailored Implementation of Measurement Based Care (Behavioral)

Standardized Implementation, Therapists

Experimental

Sites randomized to the standardized condition will be expected to use the measurement-based care intervention (PHQ-9) prior to each session with a depressed client and they will work as a team to maximize fidelity.

干预措施: Standard Implementation of Measurement Based Care (Behavioral)

Tailored Implementation, Therapists

Experimental

Sites randomized to the tailored condition will develop a site-specific protocol for use of the measurement-based care intervention (PHQ-9), and they will work as a team to maximize the fit of measurement-based care to this clinic.

干预措施: Tailored Implementation of Measurement Based Care (Behavioral)

结局指标

主要结局

Patient Health Questionnaire

时间窗: Week 0 (baseline) and Week 12 of treatment

Patient Health Questionnaire-9 (PHQ-9): screening tool for depression that can be used to monitor symptom change over time and inform care. Minimum value: 0 Maximum value: 27 Higher scores indicate a greater severity of depression (i.e., worse outcome).

PHQ-9 Completed Fidelity

时间窗: 5-month implementation window

PHQ-9 fidelity was monitored for each individual psychotherapy session. Fidelity was scored as: (1) Therapist did not complete or record any PHQ-9 scores; (2) Therapist completed PHQ-9 and recorded scores in the EHR only; or (3) Therapist completed PHQ-9, recorded scores in the EHR, and discussed scores with the patient. The unit of measure is the number individual psychotherapy sessions conducted during the 5-month implementation window. Patient data were included for any patient at least 18 years old at the time of their first session with a participating therapist, regardless of if the patient was enrolled in the study.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lewis

Associate Investigator

Kaiser Permanente

研究点 (6)

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