ASSIST: A Surveillance Study of Illicit Substance Toxicity (ASSIST)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Drug Effect; Drug Use; Drug Abuse; Drug Toxicity; Illicit Drug Use; Overdose, Drug; Illicit Drug Overdose; Illicit Drug Intoxication
• Intervention / Treatment: Diagnostic test: Surplus sample toxicology analysis

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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Lisa C Dunlop, MBChB, BSc FRCEM; Phone Number: 0141 452 2930/1; Email: lisa.dunlop2@nhs.scot
• Study Contact Backup: Name: David J Lowe, MBChB BMSc FRCEM; Phone Number: 01414522840; Email: david.lowe@glasgow.ac.uk

Study Locations

• United Kingdom
  • Glasgow, United Kingdom, G51 4FT
    • Recruiting
    • Queen Elizabeth University Hospital, NHS GGC
    • Contact: David J Lowe, MBChB BMSc FRCEM; Phone Number: 01414522840; Email: david.lowe@glasgow.ac.uk
    • Contact: Lisa C Dunlop, MBChB, BSc, FRCEM; Phone Number: 0141 452 2930/1; Email: lisa.dunlop2@nhs.scot
    • Sub-Investigator: James Dear, PhD FRCP
    • Sub-Investigator: Matthew Walters, MBE MD FRCP
    • Sub-Investigator: Fraser Denny, MBChB FRCEM
    • Sub-Investigator: Malcolm WG Gordon, MBChB FRCS FRCEM
    • Sub-Investigator: Vicki Craik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Stage 1: All adult patients attending Queen Elizabeth University Hospital ED due to acute illicit substance use. The target is 1000 patients.

Stage 2: Patients from stage 1 with moderate / severe toxicity as described in section 7.1. The target number of participants in this study is 500.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stage 1: Usual Care clinical data: 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; 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; Anonymised surplus blood sample will be analysed for drugs and their metabolites by way of Mass Spectrometry and LGC Group, Cambridge.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: Public Health Scotland
• Investigators: Principal Investigator: David J Lowe, MBChB BMSc FRCEM, NHS GGC R&I Non Commerical (Sponsor) Research Coordinator

Publications and helpful links

General Publications

• UK Public General Acts. Misuse of Drugs Act 1972 Schedule 2. Available from legislation.gov.uk. Accessed 25/02/2022
• The Misuse if Drugs Regulations 2001, Dangerous Drugs. Available from legislation.giv.uk. Accessed 25/02/2022.
• EMCDDA. European Drug Report, trends and Developments 2021. Available from https://www.emcdda.europa.eu/system/files/publications/13838/TDAT21001ENN.pdf accessed 14/02/2022
• National Records of Scotland. Drug-related deaths in Scotland in 2020, published 30/07/21. Available from https://www.nrscotland.gov.uk. Accessed 14/02/2022.
• Public Health Scotland, Drug-related Hospital Statistics, Scotland 2019 - 2020. Published 15/06/2021. Available from https://publichealthscotland.scot/. Accessed 14/02/2022
• Scottish Government. Evidence-Based Strategies for Preventing Drug-Related Deaths in Scotland, Our Emergency Response. January 2020. Available from https://www.gov.scot/. Accessed 10/02/2021
• Di Rico R, Nambiar D, Stoove M, Dietze P. Drug overdose in the ED: a record linkage study examining emergency department ICD-10 coding practices in a cohort of people who inject drugs. BMC Health Serv Res. 2018 Dec 5;18(1):945. doi: 10.1186/s12913-018-3756-8.
• EMCDDA. Drug-related deaths and mortality in Europe. Update from EMCDDA expert network July 2019. Available from https://www.emcdda.europa.eu. Accessed 09/02/2020
• European Monitoring Centre for Drugs and Drug Addiction. (2016) Health responses to new psychoactive substances. Available from http://www.emcdda.europa.eu/system/files/publications/2812/TD0216555ENN.pdf. Accessed 15/02/2022
• European Monitoring Centre for Drugs and Drug Addiction (2021), European Drug Report 2021: Trends and Developments, Publications Office of the European Union, Luxembourg.
• Office for National Statistics. Drug misuse in England and Wales: year ending March 2020 09/12/2020. Accessed 16/02/2022
• Deaths mentioning a new psychoactive substance by broad age-group, England and Wales, 2011 to 2015 registrations. 18 January 2017. Available from: https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/deaths/adhocs/06556deathsmentioninganewpsychoactivesubstancebybroadagegroupenglandandwales2011to2015registrations. Accessed 19/12/2018
• Adams AJ, Banister SD, Irizarry L, Trecki J, Schwartz M, Gerona R. "Zombie" Outbreak Caused by the Synthetic Cannabinoid AMB-FUBINACA in New York. N Engl J Med. 2017 Jan 19;376(3):235-242. doi: 10.1056/NEJMoa1610300. Epub 2016 Dec 14.
• Seywright A, Torrance HJ, Wylie FM, McKeown DA, Lowe DJ, Stevenson R. Analysis and clinical findings of cases positive for the novel synthetic cannabinoid receptor agonist MDMB-CHMICA. Clin Toxicol (Phila). 2016 Sep;54(8):632-7. doi: 10.1080/15563650.2016.1186805. Epub 2016 May 23.
• Hikin L, Smith PR, Ringland E, Hudson S, Morley SR. Multiple fatalities in the North of England associated with synthetic fentanyl analogue exposure: Detection and quantitation a case series from early 2017. Forensic Sci Int. 2018 Jan;282:179-183. doi: 10.1016/j.forsciint.2017.11.036. Epub 2017 Nov 29.

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2022
• Primary Completion (Anticipated): August 19, 2023
• Study Completion (Anticipated): August 19, 2023

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: April 8, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): September 19, 2022
• Last Update Submitted That Met QC Criteria: September 16, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Drug-Related Side Effects and Adverse Reactions; Drug Overdose
• Other Study ID Numbers: GN21AE239

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No