NCT04099719

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 4, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 23, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

December 18, 2019

Status Verified

December 1, 2019

Enrollment Period

4 months

First QC Date

July 4, 2019

Last Update Submit

December 17, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Construct a GIS map of the coverage of each community pharmacy in Tayside for Opiate Substitution Therapy (OST) dispensing

    1 year

  • Construct a GIS map of the coverage of each IEP site in Tayside

    1 year

  • Construct a GIS map of Drug litter finds e.g. discarded needles reported to council colleagues for safe disposal

    1 year

  • Non-fatal overdoses mapped onto a HEAT map.

    1 year

  • Drug deaths mapped onto a HEAT map

    1 year

  • +1 more secondary outcomes

Study Arms (1)

Anyone (>16 years old) registered with services providing drug

retrospective data, no intervention to be administered

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Anyone (\>16 years old) registered with services providing drug treatment and harm reduction activities in Tayside

You may qualify if:

  • 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.

You may not qualify if:

  • Data that does not identify 4 digit postcode unit of residence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Directorate of Public Health

Dundee, Tayside, DD3 8EA, United Kingdom

Location

Study Officials

  • Sarah R Donaldson, MRPharmS

    NHS Tayside

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 4, 2019

First Posted

September 23, 2019

Study Start

July 1, 2019

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

December 18, 2019

Record last verified: 2019-12

Locations