Bipolar Disorder, Depression
Conditions
Keywords
Care Management, Chronic Care Model, Mood Disorders
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.
Interventions
The mood disorders CCM intervention (Life Goals Collaborative Care) consists of: (a) a web-based patient self-management skills enhancement (CCM-1), (b) enhanced information flow and continuity of care via a care manager (CCM-2), and (c) decision support, or situation-specific evidence-based clinical practice guideline recommendations for providers (CCM-3). The CCM will be implemented utilizing telephonic contact with patients and providers by an Aetna care managers.The care managers will also use the Life Goals web portal as a guide for each session.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health-related Quality of Life, as Measured by the Mental Health Component Score | 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) | 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. |
Countries
United States
Participant flow
Pre-assignment details
A total of 280 participants were consented and enrolled to participate. Of those 280 participants, only 238 completed the baseline survey and were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Educational Control Patients will receive their usual care from providers at their clinic. They will also receive in the mail a self-guided workbook.
Educational Control | 123 |
| Chronic Care Model for Mood Disorders Life Goals Collaborative Care
Chronic Care Model for Mood Disorders: The mood disorders CCM intervention (Life Goals Collaborative Care) consists of: (a) a web-based patient self-management skills enhancement (CCM-1), (b) enhanced information flow and continuity of care via a care manager (CCM-2), and (c) decision support, or situation-specific evidence-based clinical practice guideline recommendations for providers (CCM-3). The CCM will be implemented utilizing telephonic contact with patients and providers by an Aetna care managers.The care managers will also use the Life Goals web portal as a guide for each session. | 115 |
| Total | 238 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
| Overall Study | Lost Aetna Coverage | 43 | 40 |
| Overall Study | Lost to Follow-up | 37 | 32 |
| Overall Study | Withdrawal by Subject | 0 | 11 |
Baseline characteristics
| Characteristic | Chronic Care Model for Mood Disorders | Total | Educational Control |
|---|---|---|---|
| Age, Continuous | 42.8 years STANDARD_DEVIATION 12.9 | 41.3 years STANDARD_DEVIATION 13.1 | 39.9 years STANDARD_DEVIATION 13.2 |
| Health-related Quality of Life - Mental Health Component Score | 36.9 units on a scale STANDARD_DEVIATION 15.3 | 35.6 units on a scale STANDARD_DEVIATION 15.2 | 34.4 units on a scale STANDARD_DEVIATION 15.2 |
| Mood Disorder Symptoms | 13.0 units on a scale STANDARD_DEVIATION 7.1 | 12.7 units on a scale STANDARD_DEVIATION 6.6 | 12.4 units on a scale STANDARD_DEVIATION 6.1 |
| Race/Ethnicity, Customized Not Available | 16 Participants | 45 Participants | 29 Participants |
| Race/Ethnicity, Customized White | 99 Participants | 193 Participants | 94 Participants |
| Region of Enrollment United States | 115 participants | 238 participants | 123 participants |
| Sex: Female, Male Female | 77 Participants | 156 Participants | 79 Participants |
| Sex: Female, Male Male | 38 Participants | 82 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 123 | 1 / 115 |
| other Total, other adverse events | 0 / 123 | 0 / 115 |
| serious Total, serious adverse events | 0 / 123 | 0 / 115 |
Outcome results
Health-related Quality of Life, as Measured by the Mental Health Component Score
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.
Time frame: 12-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational Control | Health-related Quality of Life, as Measured by the Mental Health Component Score | 38.2 score on a scale | Standard Deviation 9.6 |
| Chronic Care Model for Mood Disorders | Health-related Quality of Life, as Measured by the Mental Health Component Score | 43.2 score on a scale | Standard Deviation 10.3 |
Mood Disorder Symptoms, as Measured by the Patient Health Questionnaire (9-question)
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.
Time frame: 12-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational Control | Mood Disorder Symptoms, as Measured by the Patient Health Questionnaire (9-question) | 9.3 score on a scale | Standard Deviation 4.2 |
| Chronic Care Model for Mood Disorders | Mood Disorder Symptoms, as Measured by the Patient Health Questionnaire (9-question) | 7.6 score on a scale | Standard Deviation 3.7 |