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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02041962
Enrollment
280
Registered
2014-01-22
Start date
2014-07-31
Completion date
2018-01-31
Last updated
2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Depression

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

Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED
University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Health-related Quality of Life, as Measured by the Mental Health Component Score12-monthsMental 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-monthsMood 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

ArmCount
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
Total238

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath11
Overall StudyLost Aetna Coverage4340
Overall StudyLost to Follow-up3732
Overall StudyWithdrawal by Subject011

Baseline characteristics

CharacteristicChronic Care Model for Mood DisordersTotalEducational Control
Age, Continuous42.8 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 Score36.9 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 Symptoms13.0 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 Participants45 Participants29 Participants
Race/Ethnicity, Customized
White
99 Participants193 Participants94 Participants
Region of Enrollment
United States
115 participants238 participants123 participants
Sex: Female, Male
Female
77 Participants156 Participants79 Participants
Sex: Female, Male
Male
38 Participants82 Participants44 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 1231 / 115
other
Total, other adverse events
0 / 1230 / 115
serious
Total, serious adverse events
0 / 1230 / 115

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
Educational ControlHealth-related Quality of Life, as Measured by the Mental Health Component Score38.2 score on a scaleStandard Deviation 9.6
Chronic Care Model for Mood DisordersHealth-related Quality of Life, as Measured by the Mental Health Component Score43.2 score on a scaleStandard Deviation 10.3
Primary

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

ArmMeasureValue (MEAN)Dispersion
Educational ControlMood Disorder Symptoms, as Measured by the Patient Health Questionnaire (9-question)9.3 score on a scaleStandard Deviation 4.2
Chronic Care Model for Mood DisordersMood Disorder Symptoms, as Measured by the Patient Health Questionnaire (9-question)7.6 score on a scaleStandard Deviation 3.7

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026