跳至主要内容
临床试验/NCT04321876
NCT04321876进行中(未招募)不适用

Evaluation of a Collaborative Behavioral Health Program Implementation in Primary Care

Northwestern University1 个研究点 分布在 1 个国家实际入组 778 人开始时间: 2018年9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
进行中(未招募)
入组人数
778
试验地点
1
主要终点
Impact of implementation strategies on the speed of CBHP implementation (time, in days)

研究概览

简要总结

This study will give researchers the opportunity to evaluate implementation of the Collaborative Behavioral Health Program (CBHP), based on the collaborative care model for depression, which aims to improve practice for physicians and staff; improve care for patients; and improve clinic operations through a model that allows for more efficient identification and referral for care for depression.

详细描述

This study used a hybrid Type 2 effectiveness-implementation design of a randomized roll-out trial of the Collaborative Care Model for depression (CoCM) in 11 primary care practices in a large healthcare system affiliated with an academic medical center. The Collaborative Behavioral Health Program (CBHP) is supported by leaders in the healthcare system and the primary care steering committee as a means of improving access to effective mental health services. Implementation strategies including hiring and training the necessary staff for CoCM, audit and feedback procedures, and health information technologies to assist with billing and the patient registry, will be provided for all practices. Using a sequential mixed methods measurement approach, we will assess key stakeholders' perspectives of CBHP roll-out, focused on barriers and facilitators of implementation and sustainability. The Stages of Implementation tool will be used to measure the speed and quantity of implementation activities completed across the stages of implementation preparation, implementation, and sustainment over a 30-month period for each practice. Effectiveness of CBHP for patient-level outcomes will be conducted on depressive symptoms, graduation rates for CBHP, and spillover effects on chronic health conditions.

With its focus on implementation processes and strategies, this study will elucidate the critical drivers of CoCM implementation that are understudied for a program with such a robust evidence base. This study will also be among the first to conduct economic analyses on a fee-for-service model with the new billing codes for CoCM and can inform ways to improve implementation efficiency with our optimization approach to successive practices in the roll-out design. Changes to the protocol and current status of the study are also discussed.

研究设计

研究类型
观察性
观察模型
队列研究
时间视角
前瞻性

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

  • PHQ-9 score > 10

排除标准

  • Current suicidality
  • Bipolar disorder
  • Substance abuse disorder
  • Psychosis
  • Other severe mental health condition

研究组 & 干预措施

NMG IM 259 E Erie St

干预措施: Collaborative Behavioral Health Program (Behavioral)

NMG IM 201 E Huron St

干预措施: Collaborative Behavioral Health Program (Behavioral)

NMG IM 1135 S Delano Ct

干预措施: Collaborative Behavioral Health Program (Behavioral)

NMG IM 1460 N Halsted St

干预措施: Collaborative Behavioral Health Program (Behavioral)

NMG IM 1776 N Milwaukee Ave

干预措施: Collaborative Behavioral Health Program (Behavioral)

NMG IM 211 E Chicago Ave

干预措施: Collaborative Behavioral Health Program (Behavioral)

NMG Integrative Medicine 150 E Huron St

干预措施: Collaborative Behavioral Health Program (Behavioral)

NMG IM 20 S Clark St

干预措施: Collaborative Behavioral Health Program (Behavioral)

NMG IM FM 1704 Maple Ave

干预措施: Collaborative Behavioral Health Program (Behavioral)

NMG IM ARKES

干预措施: Collaborative Behavioral Health Program (Behavioral)

NMG IM 1333 W Belmont Ave

干预措施: Collaborative Behavioral Health Program (Behavioral)

结局指标

主要结局

Impact of implementation strategies on the speed of CBHP implementation (time, in days)

时间窗: 2 years

Trends in the rate at which CBHP is implemented over successive practices, as assessed by the Universal Stages of Implementation Completion (USIC)

Impact of implementation strategies on the quantity of CBHP implementation (number of CBHP participants)

时间窗: 2 years

Trends in the number of CBHP participants over successive practices, as assessed by CBHP referrals, engagement, and treatment completion derived from the electronic health record

Acceptability of CBHP

时间窗: 2 years

Self-report of key stakeholders and CBHP utilization (referral, engagement, completion)

Effectiveness of CBHP on depressive symptoms (PHQ-9 scores)

时间窗: 2 years

Pre- and post-treatment self-reported depressive symptoms (PHQ-9 scores), anti-depressant medication prescriptions and adherence, treatment engagement, psychiatry referrals

Effectiveness of CBHP on behavioral health service utilization (antidepressant medication prescription, CBHP treatment engagement, and external referrals for behavioral health)

时间窗: 2 years

Proportion of patients who are eligible for CBHP who receive behavioral health services, including anti-depressant medication prescriptions, CBHP treatment sessions, and/or external referrals for behavioral health (e.g., psychiatry)

次要结局

未报告次要终点

研究者

申办方类型
其他
责任方
主要研究者
主要研究者

Allison Carroll

Assistant Professor

Northwestern University

研究点 (1)

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标识符

NCT 编号
NCT04321876
其他研究编号
STU00208338

日期

首次提交
(6年前)
首次发布
(6年前)
主要完成日期
(2年前)
研究完成日期
(3个月后)
最近核实
(6个月前)
最近更新
(6天前)

监管与共享

FDA 监管药物
否
FDA 监管器械
否
个体参与者数据共享计划
UNDECIDED
是否有结果
否

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