High Deductible Health Plans and Bipolar Disorder

NCT02560701 | Completed Results DMC

• 1 other identifier: IHS-1408-20393
• Study Type: observational
• Target: 350,823
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bipolar Disorder

Keywords

high-deductible health plans; medication adherence

Outcome Measures

Primary Outcomes (3)

• Inpatient Hospitalizations Among Bipolar Patients

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

  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

  Year 3

• Medication Adherence for Bipolar Disorder

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

  YEAR 2

Secondary Outcomes (2)

• Access To Outpatient Services for Bipolar Disorder

  YEAR 2

• Medication Adherence for Bipolar Disorder - Psychotropic Medications

  YEAR 2

Other Outcomes (1)

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

  YEAR 2, YEAR 3

Interventions

Patient Interview OTHER

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.

Eligibility Criteria

• Age: 12 Years - 63 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• \[Intervention Cohort\]:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harvard Pilgrim Health Care: lead
• Depression and Bipolar Support Alliance: collaborator
• NAMI: National Alliance on Mental Illness: collaborator

MeSH Terms

Conditions

Bipolar Disorder; Medication Adherence

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

This study had the following limitations: 1) observational and therefore subject to unmeasured confounding; 2) utilized a claims based diagnosis of bipolar disorder (not gold standard); 3) not generalizable to low-income people with bipolar disorder

Results Point of Contact

• Title: Dr. J. Frank Wharam
• Organization: Harvard Pilgrim Health Care Institute

jwharam@post.harvard.edu

(617) 867-4948

Study Officials

• James F Wharam, MD, MPH

  Harvard Pilgrim Health Care Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2015
• First Posted: September 25, 2015
• Study Start: September 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 6, 2020
• Results First Posted: July 24, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share