Clinical trial NCT02041962: Implementing Health Plan-Level Care Management for Solo & Small Practices
Official title: Implementing Health Plan-Level Care Management for Solo & Small Practices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Depression
Keywords: Care Management
Chronic Care Model
Mood Disorders
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2014-01-22
Enrollment: 280
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Health-related Quality of Life, as Measured by the Mental Health Component Score
timeFrame: 12-months
measure: Mood Disorder Symptoms, as Measured by the Patient Health Questionnaire (9-question)
timeFrame: 12-months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Amy M Kilbourne, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kilbourne AM, Prenovost KM, Liebrecht C, Eisenberg D, Kim HM, Un H, Bauer MS. Randomized Controlled Trial of a Collaborative Care Intervention for Mood Disorders by a National Commercial Health Plan. Psychiatr Serv. 2019 Mar 1;70(3):219-224. doi: 10.1176/appi.ps.201800336. Epub 2019 Jan 3.
citation: Kilbourne AM, Nord KM, Kyle J, Van Poppelen C, Goodrich DE, Kim HM, Eisenberg D, Un H, Bauer MS. Randomized controlled trial of a health plan-level mood disorders psychosocial intervention for solo or small practices. BMC Psychol. 2014 Nov 13;2(1):48. doi: 10.1186/s40359-014-0048-x. eCollection 2014.