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Geographical Information System (GIS) Mapping to Assess the Need for IEP Provision in Tayside

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099719
Recruitment Status : Completed
First Posted : September 23, 2019
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
Sarah Donaldson, NHS Tayside

Tracking Information
First Submitted Date July 4, 2019
First Posted Date September 23, 2019
Last Update Posted Date December 18, 2019
Actual Study Start Date July 1, 2019
Actual Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 19, 2019)
GIS mapping of IEP and overdose prevention activity across Tayside [ Time Frame: 1 year ]
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 19, 2019)
  • Construct a GIS map of the coverage of each community pharmacy in Tayside for Opiate Substitution Therapy (OST) dispensing [ Time Frame: 1 year ]
    4 digit postcodes of OST prescriptions from Controlled Drug database for each community pharmacy
  • Construct a GIS map of the coverage of each IEP site in Tayside [ Time Frame: 1 year ]
    4 digit postcodes of those accessing IEP sites recorded on NEO database
  • Construct a GIS map of Drug litter finds e.g. discarded needles reported to council colleagues for safe disposal [ Time Frame: 1 year ]
    Postcode of locations of drug litter finds
  • Non-fatal overdoses mapped onto a HEAT map. [ Time Frame: 1 year ]
    4 digit postcode of patients experiencing Non-fatal overdoses (NFOD) from NFOD database
  • Drug deaths mapped onto a HEAT map [ Time Frame: 1 year ]
    4 digit postcode of those lost to Drug Deaths from Drug Death database
  • Take Home Naloxone supply data mapped [ Time Frame: 1 year ]
    4 digit postcode information for people supplied naloxone on naloxone database
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Geographical Information System (GIS) Mapping to Assess the Need for IEP Provision in Tayside
Official Title A GIS Mapping Exercise to Assess the Need for Injecting Equipment Provision (IEP) Services and Overdose Prevention Activities in Tayside.
Brief 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.
Detailed 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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Anyone (>16 years old) registered with services providing drug treatment and harm reduction activities in Tayside
Condition Drug Use
Intervention Not Provided
Study Groups/Cohorts Anyone (>16 years old) registered with services providing drug
retrospective data, no intervention to be administered
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 19, 2019)
2000
Original Estimated Enrollment Same as current
Actual Study Completion Date October 31, 2019
Actual Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04099719
Other Study ID Numbers 3-010-18
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Sarah Donaldson, NHS Tayside
Study Sponsor NHS Tayside
Collaborators Not Provided
Investigators
Principal Investigator: Sarah R Donaldson, MRPharmS NHS Tayside
PRS Account NHS Tayside
Verification Date December 2019