NCT05944133

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). 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
27,257

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 13, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

October 17, 2024

Status Verified

October 1, 2024

Enrollment Period

1.9 years

First QC Date

July 5, 2023

Last Update Submit

October 15, 2024

Conditions

Opioid Use DisorderOpioid OverdoseDeath

Keywords

Health Insurance InstabilityMedications for Opioid Use DisorderTreatment Retention

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Patients enrolled

Patients who are enrolled on health plans during active MOUD treatment.

Other: No intervention, observational retrospective study

Patients who disenrolled

Patients who disenrolled from health plans during active MOUD treatment.

Other: No intervention, observational retrospective study

Interventions

No intervention, observational retrospective studyOTHER

No intervention

Patients enrolledPatients who disenrolled

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Colorado

Aurora, Colorado, 80014, United States

Location

MeSH Terms

Conditions

Opioid-Related DisordersOpiate OverdoseDeath

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDrug OverdosePrescription Drug MisuseDrug MisusePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anh P Nguyen, PhD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

  • Ingrid A Binswanger, MD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

  • Jason M Glanz, PhD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 5, 2023

First Posted

July 13, 2023

Study Start

March 29, 2023

Primary Completion

February 28, 2025

Study Completion

February 28, 2026

Last Updated

October 17, 2024

Record last verified: 2024-10

Locations

US(1)