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High Deductible Health Plans and Bipolar Disorder

Impact of High Deductible Health Plans on Patients With Bipolar Disorder

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02560701
Enrollment
350823
Registered
2015-09-25
Start date
2015-09-30
Completion date
2018-08-31
Last updated
2020-08-06

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

Conditions

Bipolar Disorder

Keywords

high-deductible health plans, medication adherence

Brief summary

Using eleven years (2004-2014) of claims data from the largest US commercial health insurer, the investigators will assess the impact of switching into high-deductible health plans (HDHPs) on outcomes for patients with bipolar disorder. Patient subgroups will include patients with and without high medication cost-sharing and vulnerable populations (racial/ethnic minorities, poor, rural, major comorbidities). Interviews with patients and caregivers recruited through a major advocacy group will provide further insights into the policy issues with real-life experiences.

Detailed description

Bipolar disorder is a severe mental illness affecting about 3% of the U.S. population that causes personal suffering, morbidity, and premature mortality. Continuous access to medications, close monitoring, and other psychiatric care are crucial for avoiding complications of bipolar disorder such as relapse, hospitalization, and suicide. To control rising costs, payers and employers are increasingly adopting high-deductible health plans (HDHPs) with very high out-of-pocket payments. Federally-defined Health Savings Account HDHPs require full cost-sharing for all non-preventive services, including medications and specialist visits; family deductibles for HSA-HDHPs range from $2,500 to $12,700. Enrollment in HDHPs quadrupled nationally between 2006 and 2013 to 38% of all workers. Analysts expect further explosive growth because of continued health care cost pressure on families and employers. Well-informed patients in HDHPs might reduce use of unnecessary services and more expensive treatment options. However, patients might also choose to forego needed care. There is very little evidence on how particularly vulnerable patients such as those with bipolar disorder or other chronic mental illnesses fare when forced to make complex choices about spending for care under HDHPs. Given their rapid escalation, there is an urgent need to understand how vulnerable patients change their patterns of care and medication adherence under HDHPs. We will compare patients with three types of insurance: traditional plans with low or no deductible; HDHPs in which chronic medications are paid fully out-of-pocket until the deductible is met; and HDHPs where medications are subject to the same co-pays as in traditional plans. OBJECTIVES: Using ten years of data from the largest U.S. commercial health insurer (\ 70 million members in all 50 states), we will assess the impact of HDHPs on key outcomes for patients with bipolar disorder experiencing employer-mandated shifts from traditional insurance to HDHPs. Our specific aims are to evaluate: (1) changes in medication adherence, and in intensity and quality of other health care; (2) changes in adverse events; and, (3) changes in patient out-of-pocket costs. We will compare how these outcomes differ for patients in HDHPs with and without medications subject to the deductible. We will assess effects in the overall population of patients with bipolar illness and in specific vulnerable subgroups, including racial/ethnic minorities, poorer patients, rural patients, and patients with other important comorbidities. METHODS: We will take advantage of an ongoing natural experiment whereby employers have shifted all their employees at once from traditional insurance to HDHPs. We will use the strongest quasi-experimental, longitudinal methods available to compare the experience of patients switched by their employers into HDHPs with contemporaneous patients whose employers remain in traditional plans. A major advantage of our approach is the inclusion of only employers whose employees had no choice of insurance plans, minimizing member-level selection bias. From preliminary data queries, we estimate a study population of \ 160,000 members with bipolar disorder from 2004-2013. Our data include detailed information about insurance type, diagnoses, health services and pharmacy utilization, out-of-pocket payments, individual-level patient characteristics like income, and neighborhood-level factors like racial density. The unprecedented large sample size will allow us to answer questions about how patients from particular vulnerable subgroups respond to HDHPs, including patients who are Black or Hispanic, have low incomes, reside in rural areas, and have major comorbidities. PATIENT OUTCOMES: Our Aim 1 measures of the quality of bipolar treatment will include indicators of patients' access to appropriate care: prevalence and intensity of use of effective medications (antipsychotics, anticonvulsants); medication adherence; and, guideline-recommended clinical monitoring (regular outpatient mental health visits). Adverse events in Aim 2 will include psychiatric hospitalizations, which are potentially avoidable and often viewed as an indicator of suboptimal outpatient care. In Aim 3, we will assess changes under HDHPs in the co-payment amounts faced by patients for specific medical services, such as prescription fills and clinician visits, and the total burden of patient out-of-pocket costs. PATIENT AND STAKEHOLDER ENGAGEMENT: Our longstanding engagement with the National Alliance on Mental Illness (NAMI, the preeminent patient advocacy organization addressing issues around bipolar disorder) has shaped our study aims and our focus on measurable outcomes of particular concern to patients. We will solicit regular input from a local patient and family advisory panel (assembled with NAMI's assistance) on the refinement of methods, interpretation of study findings, shaping of recommendations, and dissemination of results. As study consultant, NAMI Medical Director Dr. Ken Duckworth will guide meetings of the patient panel and contribute perspectives from the broader community of patients and clinicians dealing with bipolar illness. Dr. Greg Simon, Director of the US Mental Health Research Network, will provide national expertise on patient experiences with serious mental illness in health plans. ANTICIPATED IMPACT: Our research will provide empirical data comparing how patients with bipolar illness fare under three insurance designs with vastly different requirements for cost-sharing. At a time when HDHP enrollment is exploding, the experience of patients with serious mental illnesses is largely unexamined. Advocacy groups will be able to use our findings to lobby for more patient-responsive benefit designs; policymakers will have evidence to redesign insurance benefits to better address the needs of vulnerable patients (e.g., by exempting mood stabilizing agents from deductibles).

Interventions

Investigators will conduct in-depth interviews with approximately 40 commercially insured individuals with bipolar disorder or their family caregivers to explore how they navigate deductibles, copayments, and other complex insurance features. Investigators will also determine the health care services that patients most value and assess how they prioritize difficult health care cost tradeoffs.

Sponsors

Depression and Bipolar Support Alliance
CollaboratorUNKNOWN
NAMI: National Alliance on Mental Illness
CollaboratorUNKNOWN
Harvard Pilgrim Health Care
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 63 Years
Healthy volunteers
Yes

Inclusion criteria

(for both study intervention/control groups): \[Intervention Cohort\]: * Traditional plan members with bipolar illness. * Experience an employer-mandated switch to HSA-eligible HDHPs with full drug cost-sharing. \[Control Cohort\]: * Members with bipolar illness. * Members whose employers offered only a traditional plan for the follow-up year.

Exclusion criteria

* Members age 65 years or older who could be eligible for Medicare benefits, including drug coverage through Medicare Part D. * Members whose employer offered a choice of health plan.

Design outcomes

Primary

MeasureTime frameDescription
Inpatient Hospitalizations Among Bipolar PatientsYear 3Mean number of annual inpatient hospitalizations in the follow-up period among bipolar patients
Emergency Department Visits Among Patients With Bipolar DisorderYear 3Mean number of annual emergency department visits in the follow-up period among bipolar patients
Medication Adherence for Bipolar DisorderYEAR 2Mean number of annual bipolar medication fills in the follow-up period among bipolar patients

Secondary

MeasureTime frameDescription
Access To Outpatient Services for Bipolar DisorderYEAR 2Mean number of annual outpatient mental health visits for bipolar patients, averaged across baseline and follow-up periods
Medication Adherence for Bipolar Disorder - Psychotropic MedicationsYEAR 2Mean number of annual psychotropic medication fills in the follow-up period among bipolar patients

Other

MeasureTime frameDescription
Annual Patient Out-of-pocket Costs for Patients With Bipolar DisorderYEAR 2, YEAR 3Annual patient out-of-pocket costs (paid deductible, coinsurance, and copayment amounts) for patients with Bipolar Disorder in the baseline period

Participant flow

Recruitment details

Participants were identified in claims data. Each was required to have one inpatient episode or two outpatient visits with a corresponding diagnosis of bipolar disorder. Patients with schizophrenia or schizoaffective disorder were excluded.

Pre-assignment details

Study participants without either a) two years of continuous enrollment in a low-deductible health plan OR b) one year of enrollment in a low-deductible plan followed by a continuous year of enrollment in a high-deductible plan were excluded. This brought the sample size from 350,823 to 97,302.

Participants by arm

ArmCount
High-Deductible Health Plan Group
Insurance plan members with one year in a low-deductible plan (less than or equal to $500 per year), followed by an employer mandated switch to a high-deductible plan (greater than or equal to $1,000 per year)
3,517
Control Group
Insurance plan members with two consecutive years in employer-mandated low-deductible plans (less than or equal to $500 per year)
37,776
Total41,293

Baseline characteristics

CharacteristicHigh-Deductible Health Plan GroupTotalControl Group
Age, Continuous38.3 years
STANDARD_DEVIATION 13.7
38.3 years
STANDARD_DEVIATION 14.1
38.3 years
STANDARD_DEVIATION 14.1
Ethnicity (NIH/OMB)
Hispanic or Latino
126 Participants1584 Participants1458 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
3391 Participants39709 Participants36318 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
38 Participants557 Participants519 Participants
Race (NIH/OMB)
Black or African American
29 Participants451 Participants422 Participants
Race (NIH/OMB)
More than one race
685 Participants9386 Participants8701 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
166 Participants2318 Participants2152 Participants
Race (NIH/OMB)
White
2599 Participants28581 Participants25982 Participants
Region of Enrollment
United States
Midwest
1203 Participants12206 Participants11003 Participants
Region of Enrollment
United States
Northeast
253 Participants4973 Participants4720 Participants
Region of Enrollment
United States
South
1616 Participants17899 Participants16283 Participants
Region of Enrollment
United States
West
445 Participants6215 Participants5770 Participants
Rural
Non-Urban
258 Participants2750 Participants2492 Participants
Rural
Urban
3259 Participants38543 Participants35284 Participants
Sex: Female, Male
Female
2130 Participants25283 Participants23153 Participants
Sex: Female, Male
Male
1387 Participants16000 Participants14613 Participants
Substance Use Disorder Flag
No Evidence of Substance Use Disorder
2879 Participants34372 Participants31493 Participants
Substance Use Disorder Flag
Substance Use Disorder
638 Participants6921 Participants6283 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 3,5170 / 37,776
other
Total, other adverse events
0 / 3,5170 / 37,776
serious
Total, serious adverse events
0 / 3,5170 / 37,776

Outcome results

Primary

Emergency Department Visits Among Patients With Bipolar Disorder

Mean number of annual emergency department visits in the follow-up period among bipolar patients

Time frame: Year 3

ArmMeasureValue (MEAN)Dispersion
High-Deductible Health Plan GroupEmergency Department Visits Among Patients With Bipolar Disorder0.42 ED visits per yearStandard Deviation 1.26
Control GroupEmergency Department Visits Among Patients With Bipolar Disorder0.38 ED visits per yearStandard Deviation 1.09
Primary

Inpatient Hospitalizations Among Bipolar Patients

Mean number of annual inpatient hospitalizations in the follow-up period among bipolar patients

Time frame: Year 3

ArmMeasureValue (MEAN)Dispersion
High-Deductible Health Plan GroupInpatient Hospitalizations Among Bipolar Patients0.17 hospitalizations per yearStandard Deviation 0.6
Control GroupInpatient Hospitalizations Among Bipolar Patients0.17 hospitalizations per yearStandard Deviation 0.57
Primary

Medication Adherence for Bipolar Disorder

Mean number of annual bipolar medication fills in the follow-up period among bipolar patients

Time frame: YEAR 2

ArmMeasureValue (MEAN)Dispersion
High-Deductible Health Plan GroupMedication Adherence for Bipolar Disorder0.57 Medication fills per yearStandard Deviation 3.15
Control GroupMedication Adherence for Bipolar Disorder1.42 Medication fills per yearStandard Deviation 4.47
Secondary

Access To Outpatient Services for Bipolar Disorder

Mean number of annual outpatient mental health visits for bipolar patients, averaged across baseline and follow-up periods

Time frame: YEAR 2

ArmMeasureValue (MEAN)Dispersion
High-Deductible Health Plan GroupAccess To Outpatient Services for Bipolar Disorder5.54 visits per yearStandard Deviation 8.48
Control GroupAccess To Outpatient Services for Bipolar Disorder6.15 visits per yearStandard Deviation 9.54
Secondary

Medication Adherence for Bipolar Disorder - Psychotropic Medications

Mean number of annual psychotropic medication fills in the follow-up period among bipolar patients

Time frame: YEAR 2

ArmMeasureValue (MEAN)Dispersion
High-Deductible Health Plan GroupMedication Adherence for Bipolar Disorder - Psychotropic Medications0.73 medication fills per yearStandard Deviation 3.73
Control GroupMedication Adherence for Bipolar Disorder - Psychotropic Medications2.57 medication fills per yearStandard Deviation 6.92
Other Pre-specified

Annual Patient Out-of-pocket Costs for Patients With Bipolar Disorder

Annual patient out-of-pocket costs (paid deductible, coinsurance, and copayment amounts) for patients with Bipolar Disorder in the baseline period

Time frame: YEAR 2, YEAR 3

ArmMeasureValue (MEAN)Dispersion
High-Deductible Health Plan GroupAnnual Patient Out-of-pocket Costs for Patients With Bipolar Disorder1674.61 U.S. Dollars per yearStandard Deviation 1576.04
Control GroupAnnual Patient Out-of-pocket Costs for Patients With Bipolar Disorder1440.45 U.S. Dollars per yearStandard Deviation 1510.86

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026