Health Insurance Instability and Mortality Among Patients Receiving Bup Tx for OUD

Health Insurance Instability and Mortality Among Patients Receiving Buprenorphine Treatment for Opioid Use Disorder

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). The main objectives of the study are:

• Objective 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.
• Objective 2: Assess the association of insurance instability and risk of death, including all-cause mortality and drug- and alcohol-related overdose mortality.

Study Overview

• Status: Active, not recruiting
• Conditions: Death; Opioid Use Disorder; Opioid Overdose
• Intervention / Treatment: Other: No intervention, observational retrospective study

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, increases 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 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 in the US.

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 Type: Observational
• Enrollment (Actual): 27257

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80014
      • Kaiser Permanente Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

We anticipate a study population of >20,000 patients based on preliminary data. There will be no study exclusion criteria based on gender, race, or ethnicity.

Description

The retrospective cohort study will consist of patients 16 years and older who received MOUD between January 1, 2012, through December 31, 2021, with follow-up through December 31, 2022. Evidence of MOUD will be determined by (1) buprenorphine with or without an OUD diagnosis and (2) naltrexone (injectable extended-release (XR) or oral; oral naltrexone is included because it may be prescribed prior to the transition to XR naltrexone) with an OUD diagnosis from pharmacy dispensing or orders data.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients enrolled; Patients who are enrolled on health plans during active MOUD treatment.	Other: No intervention, observational retrospective study; No intervention
Patients who disenrolled; Patients who disenrolled from health plans during active MOUD treatment.	Other: No intervention, observational retrospective study; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	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.	January 1, 2012 - December 31, 2022
Drug and alcohol-related overdose mortality	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.	January 1, 2012 - December 31, 2022

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid-related overdose	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.	January 1, 2012 - December 31, 2022
Self-harm/suicide mortality	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.	January 1, 2012 - December 31, 2022

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Jason M Glanz, PhD, Kaiser Permanente; Principal Investigator: Anh P Nguyen, PhD, Kaiser Permanente; Principal Investigator: Ingrid A Binswanger, MD, Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2023
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: July 5, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Medications for Opioid Use Disorder; Treatment Retention; Health Insurance Instability
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Narcotic-Related Disorders; Drug Overdose; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Opioid-Related Disorders; Opiate Overdose
• Other Study ID Numbers: 3UG1DA040314-08S4 (U.S. NIH Grant/Contract); CTN-0141 (Other Identifier: NIDA)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No