N/A
Completed N=97,302
High Deductible Health Plans and Bipolar Disorder
Source: ClinicalTrials.gov NCT02560701 ↗Enrolled (actual)
97,302
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: Inpatient Hospitalizations Among Bipolar Patients — 0.17; 0.17 hospitalizations per year
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inpatient Hospitalizations Among Bipolar Patients |
0.17; 0.17 | — |
| PRIMARY Emergency Department Visits Among Patients With Bipolar Disorder |
0.42; 0.38 | — |
| PRIMARY Medication Adherence for Bipolar Disorder |
0.57; 1.42 | — |
| SECONDARY Access To Outpatient Services for Bipolar Disorder |
5.54; 6.15 | — |
| SECONDARY Medication Adherence for Bipolar Disorder - Psychotropic Medications |
0.73; 2.57 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02560701). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.