Health Insurance Instability Among Patients Receiving Bup Tx for OUD
Study Details
Study Description
Brief Summary
The goal of this multi-site observational cohort study is to link electronic health records (EHR) with novel data sources to examine insurance instability and its association with all-cause and overdose mortality in adult patients who received medications for opioid use disorder (MOUD) across four health systems. The main questions it aims to answer are:
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Aim 1. Perform data linkage of a cohort of patients who received MOUD with the National Death Index using a probabilistic algorithm for matching records to ascertain fact and cause of death relative to treatment and insurance status.
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Aim 2: Examine insurance instability and associated patient characteristics, health plan, and MOUD treatment characteristics.
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Aim 3: Assess the association of insurance instability and risk of death, including all-cause mortality and drug- and alcohol-related overdose mortality.
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Aim 4: Link patient data from one study site with all-payer claims data and criminal justice data to explore outcomes associated with disenrollment from health plans.
Researchers will compare adult patients who received MOUD to a general population that do not have a history of opioid use disorder with comparable demographics (matched on age, race, ethnicity and gender) to see if patients prescribed MOUD experience insurance instability more frequently and have higher mortality risk compared to the general population.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Amidst the current opioid epidemic, the incidence of opioid use disorder (OUD) has increased and medication-based treatments for opioid use disorder (MOUD) remain underutilized. While long-term MOUD is generally associated with improved health and mortality outcomes, maintaining continuous health insurance coverage is a significant challenge to sustained treatment access. Patients with OUD are likely susceptible to experiencing insurance instability due to volatile employment and variable eligibility for public insurance, which results in frequent plan changes and critical coverage gaps. The economic crisis associated with the current COVID-19 pandemic may result in greater insurance coverage instability and losses, which would leave patients with OUD even more vulnerable. High-risk care transitions and significant disruption of treatment, including discontinuation of OUD treatment, increased risk of relapse, overdose, and mortality. Further, heightened vulnerability to insurance instability among racial/ethnic minorities may contribute to observed disparities in addiction treatment access and retention. Despite the potential for insurance instability to create significant barriers to OUD treatment continuity, current knowledge regarding its health and mortality impacts is limited due to the challenge of capturing and evaluating patient outcomes after disenrollment from health systems.
To address this knowledge gap, this Clinical Trials Network (CTN) research study will examine the association of health insurance instability and mortality risk among patients receiving buprenorphine treatment for opioid use disorder in a multi-site cohort study, leveraging data across four diverse health systems participating in the CTN Health Systems Node: Kaiser Permanente (KP) Colorado (KPCO), KP Northern California (KPNC), KP Southern California (KPSC), and Henry Ford Health System (HFHS).
Findings from the study can inform strategies to ensure treatment continuity and promote well-being for patients vulnerable to insurance instability, from utilizing insurance navigators to establishing standards for bridge prescriptions of MOUD during enrollment transitions, and developing policies to address coverage gaps, such as insurance subsidies for people with OUD using opioid settlement funds. Additionally, as EHR data are increasingly important for pragmatic trials, this study will also advance intervention research by identifying data sources and methods to address bias from loss to follow-up, a common concern across clinical trials.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| KPCO Adult patients at Kaiser Permanente Colorado aged 16 years and older who received medications for opioid use disorder between January 1, 2012 and December 31, 2022. |
Other: No intervention, observational retrospective study
No intervention
|
| KPNC Adult patients at Kaiser Permanente Northern California aged 16 years and older who received medications for opioid use disorder between January 1, 2012 and December 31, 2022. |
Other: No intervention, observational retrospective study
No intervention
|
| KPSC Adult patients at Kaiser Permanente Southern California aged 16 years and older who received medications for opioid use disorder between January 1, 2012 and December 31, 2022. |
Other: No intervention, observational retrospective study
No intervention
|
| HFH Adult patients at Henry Ford Health System aged 16 years and older who received medications for opioid use disorder between January 1, 2012 and December 31, 2022. |
Other: No intervention, observational retrospective study
No intervention
|
Outcome Measures
Primary Outcome Measures
- All-cause mortality [January 1, 2012 - December 31, 2022]
Death and cause-of-death data from the National Death Index (NDI) will serve as the primary data source for outcomes. Outcome will be identified across follow-up from start of treatment and up to one year after disenrollment from the health system.
- Drug and alcohol-related overdose mortality [January 1, 2012 - December 31, 2022]
Death and cause-of-death data from the National Death Index (NDI) will serve as the primary data source for outcomes. Outcome will be identified across follow-up from start of treatment and up to one year after disenrollment from the health system.
Secondary Outcome Measures
- Opioid-related overdose [January 1, 2012 - December 31, 2022]
Death and cause-of-death data from the National Death Index (NDI) will serve as the primary data source for outcomes. Outcome will be identified across follow-up from start of treatment and up to one year after disenrollment from the health system.
- Self-harm/suicide mortality [January 1, 2012 - December 31, 2022]
Death and cause-of-death data from the National Death Index (NDI) will serve as the primary data source for outcomes. Outcome will be identified across follow-up from start of treatment and up to one year after disenrollment from the health system.
Eligibility Criteria
Criteria
Evidence of the following medications will be used to identify treatment: (a) sublingual buprenorphine, and (b) naltrexone (injectable extended-release (XR) or oral; oral naltrexone is included because it may be prescribed prior to the transition to XR naltrexone) with or without an OUD diagnosis from pharmacy dispensing (KPCO, KPNC, KPSC) or orders (HFH) data; and (c) treatment with methadone with a concurrent diagnosis of OUD from a licensed addiction treatment center. While buprenorphine is the most prescribed medication for OUD in office-based settings, we will also examine methadone and naltrexone treatment for OUD. Buprenorphine and naltrexone are FDA-approved to treat patients 16 and older. To understand the relative burdens of insurance instability and mortality risks in the main study population above compared to other populations we will compare insurance instability and mortality risks with two control populations: (1) a sample of a general population approximately equivalent in size to the study population (~37,000) and matched on demographics and (2) a population of individuals with an OUD diagnosis but no evidence of receiving MOUD. For the latter population, we expect a population of approximately 170,000 individuals.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kaiser Permanente Colorado | Aurora | Colorado | United States | 80014 |
Sponsors and Collaborators
- Kaiser Permanente
- Henry Ford Health System
Investigators
- Study Chair: Xiaoming Wang, PhD, National Institute of Drug Abuse
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 3UG1DA040314-08S4
- CTN-0141