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

Opioid Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05944133
• Other study ID #: 3UG1DA040314-08S4
• Secondary ID: CTN-0141
• Status: Active, not recruiting
• Start date: March 29, 2023
• Est. completion date: February 28, 2026

Study information

• Verified date: October 2023
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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). 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20000
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Death
• Opiate Overdose
• Opioid Overdose
• Opioid Use Disorder
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

Other:
• No intervention, observational retrospective study
No intervention

Locations

Country	Name	City	State
United States	Kaiser Permanente Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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