ASSIST: A Surveillance Study of Illicit Substance Toxicity

Study Overview
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Brief Summary
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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
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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.

Official Title
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ASSIST: A Surveillance Study of Illicit Substance Toxicity - Clinical Characterisation and Toxicological Analysis of Emergency Department Presentations in Glasgow

Conditions
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Overdose, Drug, Drug Use, Drug Abuse, Drug Toxicity, Drug Effect, Illicit Drug Use, Illicit Drug Overdose, Illicit Drug Intoxication

Intervention / Treatment
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* Diagnostic Test: Surplus sample toxicology analysis


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stage 1: Usual Care clinical data:<br>The patient will firstly be identified as having attended the ED due to acute illicit drug toxicity and must fit the inclusion and exclusion criteria. The research team will complete the electronic Case Report Form (eCRF), which will include defined data. | |
| Stage 2: Surplus sampling Mass Spectrometry<br>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. | Diagnostic Test: Surplus sample toxicology analysis<br>* Anonymised surplus blood sample will be analysed for drugs and their metabolites by way of Mass Spectrometry and LGC Group, Cambridge.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of full data sets and toxicology analysis for all patient attending the ED due to acute illicit drug toxicity | 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 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical phenotyping of patients attending due to acute illicit drug toxicity compared to reported / presumed drug taken | 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 | 1 year | 
| Proportion of patients who fit stage 2 criteria with biological sample mass spectrometry toxicology analysis | 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 | 1 year | 
| Production of frequency and trend data to deliver to Public Health Scotland | 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 | 1 year | 
| Proportion of illicit drug reported to have been taken and proportion of clinician presumed drug taken accurately matching toxicology analysis | 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 | 1 year | 
| Production of automated pre-defined data capture, recording and auditing for the routine processing of drug related ED presentations that includes toxicological information | 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 | 1 year | 
| Share learning and data with Scottish Government, PHS and other NHS boards to inform national scale up | 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 | 1 year |