Ignite Creation Date:
2024-05-06 @ 7:20 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05976984
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-08
First Post:
2023-07-27
Brief Title:
Stimulant Overdose in the Medicaid Population Who is at Risk and When Are They at Risk
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Stimulant Overdose in the Medicaid Population Who is at Risk and When Are They at Risk
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This project addresses Objective 2 of RFA-CE-21-002 to assess risk and protective factors for illicit stimulant use use disorder or overdose that can contribute to the development or adaptation of intervention strategies The study will 1 develop and validate a model using both person-level and area-level characteristics to identify among Medicaid enrollees age 15 and older who is at highest risk of an inpatient hospitalization or emergency department ED encounter for overdose from cocaine or other stimulants 2 develop and validate a model to identify among those Medicaid enrollees age 15 and older at highest risk of an inpatient hospitalization or ED encounter for stimulant overdose when they are at highest risk and 3 among those Medicaid enrollees age 15 and above with a prior inpatient hospitalization or ED encounter for stimulant overdose to measure the rate of and identify risk and protective factors for a subsequent inpatient hospitalization or ED encounter for overdose from stimulants andor opioids
Detailed Description:
The US drug overdose epidemic has grown dramatically in the past twenty years with more than 70000 fatal drug overdoses in 2019 alone This growth in overdose deaths is a major contributor to the multiyear decline in US life expectancy that was seen even before the COVID-19 pandemic began The drugs responsible for the largest increases in overdose deaths are synthetic opioids cocaine and other stimulants primarily methamphetamine In recognition of the increasing role that cocaine and other stimulants are playing in the drug overdose epidemic the US Centers for Disease Control and Prevention CDC has called for increased surveillance and evidence-based prevention and response strategies to address overdoses involving these agents While rates of stimulant use and overdose have been reported to vary by demographics physical and mental health conditions disability and other factors no prior research has linked individual-level data on demographics disability and social determinants of health together with granular measures derived from healthcare utilization records with comprehensive area-level data on social deprivation to develop knowledge about risk and protective factors for stimulant overdose Further no prior research has focused on stimulant overdose in Medicaid enrollees a large vulnerable underserved population in whom half of all amphetamine-related hospitalizations occur This project addresses Objective 2 of RFA-CE-21-002 to assess risk and protective factors for illicit stimulant use use disorder or overdose that can contribute to the development or adaptation of intervention strategies The study will 1 develop and validate a model using both person-level characteristics including demographic characteristics household income diagnoses prescriptions and healthcare utilization and area-level characteristics including a wide range of measures of socioeconomic deprivation to identify among Medicaid enrollees age 15 and older who is at highest risk of an inpatient hospitalization or emergency department ED encounter for overdose from cocaine or other stimulants 2 develop and validate a model to identify among those Medicaid enrollees age 15 and older at highest risk of an inpatient hospitalization or ED encounter for stimulant overdose when they are at highest risk and 3 among those Medicaid enrollees age 15 and above with a prior inpatient hospitalization or ED encounter for stimulant overdose to measure the rate of and identify risk and protective factors for a subsequent inpatient hospitalization or ED encounter for overdose from stimulants andor opioids The results will be useful in at least two ways First they will provide generalizable knowledge about the individual-level and social factors that predispose to or protect against stimulant overdose Such etiologic factors can then be the targets of intervention at the national state county and local levels to ameliorate the effects of these causes as well as the basis of future research to better understand the underlying causal mechanisms Second the results can be used pragmatically to identify high-risk individuals for the purpose of targeting scarce resources for evidence-based approaches to overdose prevention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None