跳至主要内容
临床试验/NCT02041962
NCT02041962已完成不适用

Implementing Health Plan-Level Care Management for Solo & Small Practices

University of Michigan2 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2014年7月最近更新:
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
280
试验地点
2
主要终点
Health-related Quality of Life, as Measured by the Mental Health Component Score

研究概览

简要总结

This study will determine if a version of the chronic care model for individuals with mood disorders seen in small or solo practices can improve patient health.

详细描述

A 2010 HHS report highlighted the prevalence, morbidity, and cost associated with clusters of co-occurring chronic conditions, both physical and mental. The report also underscored the lack of sustainable treatment strategies for these afflicted individuals, and the difficulties in customizing patient-centered interventions.

Collaborative chronic care models (CCMs) are effective in treating chronic medical and mental illnesses at little to no net healthcare cost. To date CCMs have primarily been implemented at the facility level and primarily developed for and adopted by larger healthcare organizations. However, we have determined that the vast majority of primary care and behavioral health practices providing commercially insured care are far too small to implement such models. Health plan-level CCMs can address this unmet need.

Chronic mood disorders (e.g., bipolar disorders, depression) are common and are associated with extensive functional impairment, medical comorbidity, and personal and societal costs. While unipolar depression is more common, bipolar disorder is more costly on a per patient basis due to its chronic and severe nature. Moreover, bipolar disorder is the most expensive mental disorder for U.S. commercial health plans and employers. While evidence-based care parameters have been well established for mood disorders, quality of care and health outcomes in general mental health practice are suboptimal. The majority of these patients suffer from clusters of comorbid conditions, both physical and mental. Thus mood disorders represent optimal tracer conditions with which to improve management strategies for individuals with multiple chronic conditions.

Accordingly, we have partnered with Aetna Inc. to develop and implement a CCM designed to improve outcomes for persons with mood disorders for solo or small practices, with an eye towards developing a business case for a generalizable plan-level CCM for chronic disorders. We will conduct an RCT of a health plan-level CCM vs. education control. The population of interest will be Aetna beneficiaries across the country hospitalized for depression or bipolar disorder treated in solo or small primary care or behavioral health practices. Patients will be randomized to one year of outpatient treatment augmented by the CCM or education control, for a total of 344 participants. Practices participation in the study will be limited to completion of an organizational survey. We anticipate 172 practices to complete these surveys. CCM care management will be fully remote from practice venues and patients, implemented by existing providers (the Aetna care management center). A business case will be developed using the Replicating Effective Programs (REP) strategy that identifies generalizable facilitators for CCM spread and value added of CCMs to be vetted to key industry and policy stakeholders.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Currently covered by Aetna's HMO or preferred provider products (for whom Aetna provides mental and medical inpatient, outpatient, and pharmacy benefits) for at least 6 months
  • Recent (past 6-month) hospitalization for an acute psychiatric or partial hospital unit with a manic or depressive episode and confirmation of mood disorder diagnosis in the medical record (presence of one inpatient or two outpatient ICD-9 codes: 296.1x-296.8x in previous 6 months)
  • Ability to speak and read English and provide informed consent
  • Current principal outpatient prescribing provider is a solo practitioner or in a practice with <=3 providers.

排除标准

  • No active substance intoxication
  • No acute medical illness or dementia

研究组 & 干预措施

Educational Control

Active Comparator

Patients will receive their usual care from providers at their clinic. They will also receive in the mail a self-guided workbook.

干预措施: Educational Control (Other)

Chronic Care Model for Mood Disorders

Experimental

Life Goals Collaborative Care

干预措施: Chronic Care Model for Mood Disorders (Behavioral)

结局指标

主要结局

Health-related Quality of Life, as Measured by the Mental Health Component Score

时间窗: 12-months

Mental Health Quality of Life was measured using the 12-item Short Form Survey (SF-12). The SF-12 has a scale range of 0-100 with higher values representing better outcomes.

Mood Disorder Symptoms, as Measured by the Patient Health Questionnaire (9-question)

时间窗: 12-months

Mood disorder symptoms were measured using the Patient Health Questionnaire (9-question). The PHQ-9 has a scale range of 0-27 with lower values representing better outcomes.

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

Amy M. Kilbourne

Professor

University of Michigan

研究点 (2)

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