Depression Clinical Trial
Official title:
Implementing Health Plan-Level Care Management for Solo & Small Practices
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.
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.
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