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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04099719
Other study ID # 3-010-18
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2019
Est. completion date October 31, 2019

Study information

Verified date December 2019
Source NHS Tayside
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to review the current provision of IEP services provided across Tayside and consider to what extent they are contributing to keeping this vulnerable population safe. The study will look at the coverage provided by the current service and map this against the known harms e.g. drugs litter finds, incidences of non-fatal overdoses and drug related deaths. This mapping process will then allow recommendations to be made in a strategic way to advise future service delivery plans to ensure that services are delivered that are reachable to the communities that need these valuable services.


Description:

People who inject drugs (PWIDs) do so at significant risk to themselves due to transmission of blood borne viruses (BBV), injecting injuries, bacterial infections and drug related deaths.

NHS Tayside has a responsibility for improving the health of the population. PWIDs represent a particularly vulnerable group who experience significant health inequalities as well as stigmatisation and discriminatory attitudes.

Injecting Equipment Provision (IEP) services contribute to a reduction in BBV transmission through the provision of free sterile equipment for each injection. IEP services also provide advice on good injecting technique to avoid injecting injuries and bacterial infections. Crucially they can also provide "take home naloxone". Intramuscular injection of naloxone is a first aid emergency response for potentially fatal opiate overdoses and provides more time for emergency services to attend. Supplies of "take home naloxone" are made, along with training on overdose awareness, to those individuals at risk of opioid overdose in order to reduce the risk of fatality.

IEP services contribute to a reduction in drug related deaths by engaging with those thought to be most at risk, either through poly substance use or those who are not engaged with other services

The aim of this study is to review the current provision of IEP services provided across Tayside and consider to what extent they are contributing to keeping this vulnerable population safe. The study will look at the coverage provided by the current service and map this against the known harms e.g. drugs litter finds, incidences of non-fatal overdoses and drug related deaths. This mapping process will then allow recommendations to be made in a strategic way to advise future service delivery plans to ensure that services are delivered that are reachable to the communities that need these valuable services.

The protocol has been peer reviewed by the expert working group established to review the current provision of IEP and harm reduction and overdose awareness services across Tayside

Individual consent from patients will not be sought. The data provided by the databases will be retrospective 4 digit postcode data and will not include patient identifiable information. The data obtained will not be used in any way which may influence the care of the patient.

Data collection methods will not identify individual patients.

Researchers will be accessing information from databases which they have access to as part of their routine work. Information will remain anonymous and patient confidentiality will be upheld.

Separate consents will be sought to allow council colleagues to provide information on drug litter finds.

Anonymous 4 digit postcode data will be transferred onto Geographic Information System (GIS) maps to demonstrate coverage of services mapped against known harms (non-fatal overdoses, drug related deaths and drug litter finds). GIS maps do not identify individual postcodes.

The GIS maps will be used to identify gaps in the provision of services and provide an evidence base behind recommendations to improve service provision.


Recruitment information / eligibility

Status Completed
Enrollment 2000
Est. completion date October 31, 2019
Est. primary completion date October 31, 2019
Accepts healthy volunteers
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria:

Anyone (>16 years old) registered with services providing drug treatment and harm reduction activities in Tayside Retrospective data from the identified databases which identifies 4 digit postcode unit of residence. All activity will be included regardless of patient characteristics.

Data will be gathered retrospectively from the past year.

Exclusion Criteria:

Data that does not identify 4 digit postcode unit of residence

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom Directorate of Public Health Dundee Tayside

Sponsors (1)

Lead Sponsor Collaborator
NHS Tayside

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary GIS mapping of IEP and overdose prevention activity across Tayside number and 4 digit postcode location of individuals accessing IEP services, receiving Opiate Substitution Therapy from Community Pharmacy, Number and 4 digit postcode location of naloxone kits distributed, number and 4 digit postcode location of drug deaths, number and 4 digit postcode location of non fatal overdoses, number and location of drug litter finds. 1 year
Secondary Construct a GIS map of the coverage of each community pharmacy in Tayside for Opiate Substitution Therapy (OST) dispensing 4 digit postcodes of OST prescriptions from Controlled Drug database for each community pharmacy 1 year
Secondary Construct a GIS map of the coverage of each IEP site in Tayside 4 digit postcodes of those accessing IEP sites recorded on NEO database 1 year
Secondary Construct a GIS map of Drug litter finds e.g. discarded needles reported to council colleagues for safe disposal Postcode of locations of drug litter finds 1 year
Secondary Non-fatal overdoses mapped onto a HEAT map. 4 digit postcode of patients experiencing Non-fatal overdoses (NFOD) from NFOD database 1 year
Secondary Drug deaths mapped onto a HEAT map 4 digit postcode of those lost to Drug Deaths from Drug Death database 1 year
Secondary Take Home Naloxone supply data mapped 4 digit postcode information for people supplied naloxone on naloxone database 1 year
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