Bipolar DisorderNCT02560701
High Deductible Health Plans and Bipolar Disorder
An observational study of Bipolar Disorder, run by Harvard Pilgrim Health Care.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 63 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Patient Interview
- How many people
- 350,823 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Aug 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 63 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Investigators will include health plan members aged 12 to 63 years at the beginning of the baseline period. Consistent with prior research,89-91 we will use medical claims data and a validated algorithm to identify members who had at least two ambulatory encounters or one hospital encounter with a diagnosis of bipolar disorder. Intervention cohorts will include traditional plan members with bipolar illness who experience an employer-mandated switch to HSA-eligible HDHPs with full drug cost-sharing or to HSA-ineligible HDHPs that subject medications only to copayments as in traditional health plans.
Who may be able to join
None listed.
Who cannot join
- 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.
About this study
Official title: Impact of High Deductible Health Plans on Patients With Bipolar Disorder
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.
Read the 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).
- Conditions
- Bipolar Disorder
- Being tested
- Patient Interview
- Keywords
- high-deductible health plans, medication adherence
- Medical subject headings
- Bipolar Disorder, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient InterviewOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Inpatient Hospitalizations Among Bipolar Patients
Mean number of annual inpatient hospitalizations in the follow-up period among bipolar patients
Measured: Year 3
Emergency Department Visits Among Patients With Bipolar Disorder
Mean number of annual emergency department visits in the follow-up period among bipolar patients
Measured: Year 3
Medication Adherence for Bipolar Disorder
Mean number of annual bipolar medication fills in the follow-up period among bipolar patients
Measured: YEAR 2
Secondary outcomes (2)
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
Measured: YEAR 2
Medication Adherence for Bipolar Disorder - Psychotropic Medications
Mean number of annual psychotropic medication fills in the follow-up period among bipolar patients
Measured: YEAR 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionFeb 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350,823 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Pilgrim Health Care
- Sponsor type
- University, hospital or other
- Collaborators
- Depression and Bipolar Support Alliance, NAMI: National Alliance on Mental Illness
- Responsible party
- Sponsor
- Investigators
- James F Wharam, MD, MPH, Principal investigator, Harvard Pilgrim Health Care Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560701
- Sponsor's protocol ID
- IHS-1408-20393
- Status last verified
- May 2019
- First submitted
- 24 Sep 2015
- Last updated
- 6 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Per contract with our data vendor, we are unable to share individual participant data but will maintain records internally in accordance with funder guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of High Deductible Health Plans on Patients With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT02560701
- Acronym / sponsor ID
- IHS-1408-20393
- Conditions
- Bipolar Disorder
- Keywords
- high-deductible health plans, medication adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350,823 participants (actual)
- Lead sponsor
- Harvard Pilgrim Health CareUniversity, hospital or other
- Collaborators
- Depression and Bipolar Support Alliance, NAMI: National Alliance on Mental Illness
- Study start
- Sep 2015
- Primary completion
- Feb 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 25 Sep 2015 (estimated)
- Results
- Posted 24 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 12 to 63 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Investigators will include health plan members aged 12 to 63 years at the beginning of the baseline period. Consistent with prior research,89-91 we will use medical claims data and a validated algorithm to identify members who had at least two ambulatory encounters or one hospital encounter with a diagnosis of bipolar disorder. Intervention cohorts will include traditional plan members with bipolar illness who experience an employer-mandated switch to HSA-eligible HDHPs with full drug cost-sharing or to HSA-ineligible HDHPs that subject medications only to copayments as in traditional health plans.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient InterviewInvestigators 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. | Other | – |
Primary outcome
Inpatient Hospitalizations Among Bipolar Patients
Time frame: Year 3
Mean number of annual inpatient hospitalizations in the follow-up period among bipolar patients
Emergency Department Visits Among Patients With Bipolar Disorder
Time frame: Year 3
Mean number of annual emergency department visits in the follow-up period among bipolar patients
Medication Adherence for Bipolar Disorder
Time frame: YEAR 2
Mean number of annual bipolar medication fills in the follow-up period among bipolar patients
2 secondary outcomes
Access To Outpatient Services for Bipolar Disorder
Time frame: YEAR 2
Medication Adherence for Bipolar Disorder - Psychotropic Medications
Time frame: YEAR 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Per contract with our data vendor, we are unable to share individual participant data but will maintain records internally in accordance with funder guidelines.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James F Wharam, MD, MPH principal investigator
Harvard Pilgrim Health Care Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by Harvard Pilgrim Health Care.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inpatient Hospitalizations Among Bipolar Patients (time frame: Year 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.