Bipolar Disorder Clinical Trial
Official title:
Impact of High Deductible Health Plans on Patients With Bipolar Disorder
NCT number | NCT02560701 |
Other study ID # | IHS-1408-20393 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 2015 |
Est. completion date | August 2018 |
Verified date | May 2019 |
Source | Harvard Pilgrim Health Care |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 350823 |
Est. completion date | August 2018 |
Est. primary completion date | February 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 63 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Harvard Pilgrim Health Care | Depression and Bipolar Support Alliance, NAMI: National Alliance on Mental Illness |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | YEAR 2, YEAR 3 | |
Primary | Inpatient Hospitalizations Among Bipolar Patients | Mean number of annual inpatient hospitalizations in the follow-up period among bipolar patients | Year 3 | |
Primary | Emergency Department Visits Among Patients With Bipolar Disorder | Mean number of annual emergency department visits in the follow-up period among bipolar patients | Year 3 | |
Primary | Medication Adherence for Bipolar Disorder | Mean number of annual bipolar medication fills in the follow-up period among bipolar patients | YEAR 2 | |
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 | YEAR 2 | |
Secondary | Medication Adherence for Bipolar Disorder - Psychotropic Medications | Mean number of annual psychotropic medication fills in the follow-up period among bipolar patients | YEAR 2 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05111548 -
Brain Stimulation and Cognitive Training - Efficacy
|
N/A | |
Completed |
NCT02855762 -
Targeting the Microbiome to Improve Clinical Outcomes in Bipolar Disorder
|
N/A | |
Recruiting |
NCT05915013 -
Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response
|
Phase 1 | |
Recruiting |
NCT05206747 -
Ottawa Sunglasses at Night for Mania Study
|
N/A | |
Completed |
NCT02513654 -
Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects
|
Phase 1 | |
Recruiting |
NCT06313918 -
Exercise Therapy in Mental Disorders-study
|
N/A | |
Completed |
NCT02304432 -
Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine
|
Early Phase 1 | |
Recruiting |
NCT06197048 -
Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder
|
N/A | |
Completed |
NCT03497663 -
VIA Family - Family Based Early Intervention Versus Treatment as Usual
|
N/A | |
Completed |
NCT04284813 -
Families With Substance Use and Psychosis: A Pilot Study
|
N/A | |
Completed |
NCT02212041 -
Electronic Cigarettes in Smokers With Mental Illness
|
N/A | |
Recruiting |
NCT05030272 -
Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings
|
N/A | |
Recruiting |
NCT04298450 -
ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention
|
N/A | |
Active, not recruiting |
NCT03641300 -
Efficacy of Convulsive Therapies for Bipolar Depression
|
N/A | |
Not yet recruiting |
NCT04432116 -
Time and Virtual Reality in Schizophrenia and Bipolar Disorder
|
N/A | |
Terminated |
NCT02909504 -
Gao NARASD Lithium Study
|
Phase 4 | |
Completed |
NCT02970721 -
Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
|
||
Terminated |
NCT02893371 -
Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
|
||
Recruiting |
NCT03088657 -
Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study
|
||
Recruiting |
NCT02481245 -
BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study
|
Phase 2 |