High Deductible Health Plans and Bipolar Disorder

2015-09-29 07:58:51 | BioPortfolio


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.


Aims 1 through 3 will use retrospective analysis of insurance claims to examine medical utilization patterns by human subjects. The objectives are to determine how high deductible health plans (HDHPs)—an increasingly common type of insurance coverage that has substantially lower coverage generosity—affect access to treatment, adverse outcomes, and out-of-pocket cost burden to patients with bipolar disorder. The claims dataset from 2004-2014 contains data on approximately 50 million people in all 50 states. The study sample that the investigators will draw from it will include approximately ~109,000 members aged 12-64 years with diagnosed bipolar disorder and at least 2 years of continuous enrollment in either a traditional employer-sponsored health plan, or a traditional plan that was replaced through employer mandate by a high deductible health plan. Aim 1 will assess changes under HDHPs in access to appropriate bipolar treatment, including use of effective medications and regular mental health visits. Aim 2 will assess changes in adverse events, including psychiatric emergency department visits and hospitalizations. Aim 3 will assess changes in patient out-of-pocket costs, including copayment amounts per service and total annual cost burden.

Aim 4 involves in-depth interviews with persons who live with bipolar disorder, or their family caregivers. The investigators will use data from 30-60 interviews in our qualitative analyses. Our study partner DBSA will be responsible for recruitment of interviewees. The opportunity to volunteer for participation in interviews will be presented in local DBSA chapter meetings (see Recruitment Flyer). Interested individuals will contact our co-investigator Phyllis Foxworth at DBSA (national office in Chicago), who will conduct an initial screening for eligibility, focused on insurance coverage type and achieving a rough US geographic balance. Ms. Foxworth will explain that the investigators want to speak only with persons who live with bipolar disorder, or their family caregivers, but she will not ask interested callers about their bipolar status, nor about other medical conditions, nor the age or sex of the individual with bipolar disorder. She will read a DBSA-stage telephone script briefly describing the study, which the investigators are submitting along with this application. She will ask for confirmation of their interest in participating. The contact information (name, phone number) for interested individuals who report appropriate insurance coverage types will be passed to the research team at HPHCI in Boston for additional screening, consenting, and interviews.

(If the investigators do not successfully meet their recruitment targets through Recruitment Flyers distributed at local DBSA chapter meetings, they will consider other available DBSA outreach avenues, but only after detailed protocols have been submitted to the IRB for approval and approved by the IRB.)

All Aim 4 interview respondents will be English-speaking adults. In all cases, the individual of interest living with bipolar illness will have commercial insurance obtained through an employer (own employer or family member's employer), as this situation is comparable to the claims population in Aims 1-3. Patients with Medicare, Medicaid, or military coverage will be excluded. The investigators plan to stratify the sample into two groups: patients with bipolar disorder, and family caregivers of patients with bipolar disorder, who may be able to provide perspectives about caring for patients whose illness is more severe. The investigators will also stratify the sample along two other dimensions to facilitate contrasts of interest: (1) low/no deductible insurance plan vs high deductible plan; (2) no major illness other than bipolar vs another major condition requiring continuous treatment. The screening process to ensure an adequate balance among patients vs caregivers, low/no vs high deductible plan, and major comorbidity vs no major comorbidity will be conducted by the interviewer at HPHCI in Boston prior to consenting and interviewing.

Aim 4 interview participants will be informed of our procedures and the potential risks and asked for verbal consent prior to the interview. Participants will be interviewed only if verbal informed consent is obtained beforehand. The investigators will request an IRB waiver of written consent for our in-depth interviews. By agreeing to be interviewed, respondents are also essentially consenting. The only data collected about interview respondents will be their own verbal responses. There will be no linkage to medical data or other personal health information. The investigators have no access to these data. Moreover, interview tapes and transcripts will have only new study ID numbers on them and no personal identifiers. The investigators will not create a list or file that links the name and phone number to the study ID. The names and phone numbers will be discarded within days of the screening/interview.

In the case of family member/caretakers participating in our Aim 4 interviews and responding on behalf of patients with bipolar disorder, the investigators will recommend (at the DBSA and HPHCI stage) that the caregiver talk to the patient about the caretaker's participation in the study, as an appropriate courtesy. However, in these cases, it is the family caregiver who is the research subject, providing their own perspectives as caretakers. The patient's identify and health information will be anonymous.

Participation in the Aim 4 qualitative interviews will involve open-ended phone interviews lasting approximately 60 minutes with a member of the study team. Interviews will explore how patients and caretakers access treatment for bipolar disorder, learn about insurance coverage, and make choices about care, including their priorities among services (i.e., higher- vs lower-value care). The investigators will also collect information about the state of residence, age group, sex, and race ethnicity of the individual living with bipolar, because the investigators need to be able to compare the basic demographics of our interview patient population with our claims patient population. Please see our two submitted interview guides.

The interviews will be performed exclusively at the Department of Population Medicine at the Harvard Pilgrim Health Care Institute/Harvard Medical School.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Bipolar Disorder


Patient Interview


Not yet recruiting


Harvard Pilgrim Health Care

Results (where available)

View Results


Published on BioPortfolio: 2015-09-29T07:58:51-0400

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