ASSIST: A Surveillance Study of Illicit Substance Toxicity

Recruiting

• Conditions: Drug Use; Drug Effect; Drug Toxicity; Illicit Drug Intoxication; Overdose, Drug; Drug Abuse; Illicit Drug Use; Illicit Drug Overdose
• Interventions: Diagnostic Test: Surplus sample toxicology analysis

• Registration Number: NCT05329142
• Lead Sponsor: NHS Greater Glasgow and Clyde

Brief Summary

There is a drug-related death crisis in Scotland. This study aims to collaborate with Public Health Scotland in order to assess the feasibility of introducing a surveillance system to the Emergency Department to highlight illicit drug-related attendances. This will utilise both clinical data and toxiclogical analysis of anonymised samples. The data will inform of prevalence, trend data and utcome of ED patients attending with acute illict drug toxicity.

Detailed Description

The purpose of this research is to establish the introduction of a robust toxicology surveillance system in the Emergency Department (ED) in order to inform public health interests. The study will explore the feasibility of reporting characteristics and causative agents of patients attending hospital as an emergency due illicit substance use. The term illicit substance used during this study encompasses any substance which is not prescribed to the individual and is a controlled drug as per the Misuse of Drugs act 1971 and Misuse of Drugs Regulations 2001.

The study will look at standard care clinical data from all individuals attending the Emergency Department due to acute illicit drug toxicity. Surplus blood samples will be anonymised and analysed for toxicological profiling.

The study will allow identification of emerging drug trends and will be shared contemporaneously with Public Health Scotland and inform the Scottish Government of current incidences to inform public health measures to tackle the drugs death crisis.

Study Timeline

• Study First Submitted: 2022-03-30
• Study First Submitted QC: 2022-04-08
• Study First Posted: 2022-04-14
• Study Start: 2022-08-19
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-16
• Last Update Posted: 2022-09-19
• Primary Completion: 2023-08-19
• Study Completion: 2023-08-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Age >16
• Patient attending QEUH ED directly relating to acute illicit drug use
• Patients with reported acute illicit drug use toxicity who are unwell before they are seen in the Emergency Department but appear well in the ED should also be included

Exclusion Criteria

• Condition more likely due to cause other than acute illicit drug use
• Condition due to withdrawal of drugs / alcohol
• Condition primarily related to alcohol use and no evidence of acute illicit drug use
• Attendance is due to complication of previous drug use - i.e., BBV / infected injection site (without acute drug toxicity)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stage 2: Surplus sampling Mass Spectrometry	Surplus sample toxicology analysis	The research team will select patients with acute moderate / severe toxicity, which will be defined as those requiring at least one of: * Patient admitted to hospital due to acute illicit drug toxicity * Pre-hospital cardio/pulmonary resuscitation * Any part of patient's ED care was in the Resuscitation area of the ED * Patient died in the ED or within 72 hours A surplus sample of the standard of care SST sample from this group will be analysed by way of Mass Spectrometry.

Primary Outcome Measures

Name	Time	Method
Proportion of full data sets and toxicology analysis for all patient attending the ED due to acute illicit drug toxicity	1 year	Objective: Assess the feasibility of prospective surveillance of Emergency Department presentations relating to acute illicit drug toxicity; Outcome measure: Proportion of full data sets and toxicology analysis for all patient attending the ED due to acute illicit drug toxicity

Secondary Outcome Measures

Name	Time	Method
Production of automated pre-defined data capture, recording and auditing for the routine processing of drug related ED presentations that includes toxicological information	1 year	Objective: Develop a framework to standardise data capture, recording and auditing for the routine processing of drug related ED presentations that includes toxicological information; Outcome measure: Production of automated pre-defined data capture, recording and auditing for the routine processing of drug related ED presentations that includes toxicological information
Proportion of patients who fit stage 2 criteria with biological sample mass spectrometry toxicology analysis	1 year	Objective: Establish the feasibility of ED presentation toxicological surveillance by anonymised surplus sample mass spect analysis; Outcome Measure: Proportion of patients who fit stage 2 criteria with biological sample mass spectrometry toxicology analysis
Proportion of illicit drug reported to have been taken and proportion of clinician presumed drug taken accurately matching toxicology analysis	1 year	Objective: Assess the accuracy of reported / clinician presumptive toxidrome diagnosis compared to biological sample analysis; Outcome Measure: Proportion of illicit drug reported to have been taken and proportion of clinician presumed drug taken accurately matching toxicology analysis
Production of frequency and trend data to deliver to Public Health Scotland	1 year	Objective: Describe the frequency and trends of drug related presentations to the ED, both clinically and by biological sample analysis; Outcome measure: Production of frequency and trend data to deliver to Public Health Scotland
Share learning and data with Scottish Government, PHS and other NHS boards to inform national scale up	1 year	Objective: Identify and compare options for national scale up - including the use of existing hospital toxicology facilities and additional services; Outcome measure: Share learning and data with Scottish Government, PHS and other NHS boards to inform national scale up
Clinical phenotyping of patients attending due to acute illicit drug toxicity compared to reported / presumed drug taken	1 year	Objective: Describe the clinical characteristics and reported / presumed toxicological profile of drug related presentations to the Emergency Department; Outcome measure: Clinical phenotyping of patients attending due to acute illicit drug toxicity compared to reported / presumed drug taken

Trial Locations

Locations (1)

Queen Elizabeth University Hospital, NHS GGC; 🇬🇧 Glasgow, United Kingdom