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Ambulance Calls for Substance Use and Alcohol in a Pandemic (ASAP) (ASAP)

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ClinicalTrials.gov Identifier: NCT04474444
Recruitment Status : Recruiting
First Posted : July 16, 2020
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
University of Lincoln

Brief Summary:
The Primary objective is to explore ambulance service attendance at incidents involving alcohol and/or substance use over the period of the pandemic lockdown, and the following months. This will be to determine prevalence and explore factors such as patient gender, age, ethnicity or location. Analysis will examine the calls over the course of the year prior to the lockdown, and then compare this to the period of lockdown and following months.

Condition or disease Intervention/treatment
Alcohol Use, Unspecified Substance Use Intoxication Alcohol Emergencies COVID-19 Pandemic Treatment Other: attendance by ambulance crew

Detailed Description:

The Primary objective is to explore ambulance service attendance at incidents involving alcohol and/or substance use over the period of the pandemic lockdown, and the following months. This will be to determine prevalence and explore factors such as patient gender, age, ethnicity or location. Analysis will examine the calls over the course of the year prior to the lockdown, and then compare this to the period of lockdown and following months.

A time series analysis will be conducted to examine the calls over the course of the year prior to the lockdown, and then compare this to the period of lockdown and following months. This will use the 'Interrupted Time Series' (ITS) approach. To explore this regression models will be built that examine the causal models for attendance prior to the pandemic and compared to the lockdown time frame.

A multivariable regression model will be built. Initially a Directed Acyclic Graph (DAG) will allow the identification of confounders and exposures relevant to the model. A logistic regression model will be used to calculate the relative risk of call during lockdown compared to the data prior to lockdown. The model will be fit using p<0.05 as the definition of statistical significance.

Descriptive statistics, trend analysis and predictive analysis will be conducted on the data set to determine trends across time, factors that predict patients requiring ambulance attendance, and factors that predict treatment outcomes. Missing data will be examined for systematic bias, and where found to be missing at random will be excluded from analysis. Where not missing at random, sensitivity analysis will be conducted.

Analysis will examine covariates. Age will be defined as single year continuous variable and examined in categories such as 5-year age groups. Ethnicity will be categorised as groups, such as black, Asian, other minority and mixed ethnic groups will be explored. Census data such as the deprivation, rurality, income, employment, disability and education will look at the decile as defined.

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Study Type : Observational
Estimated Enrollment : 55000 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Ambulance Calls for Substance Use and Alcohol in a Pandemic (ASAP): Exploring Attendance at Incidents Involving Substance and/or Alcohol Use During COVID-19 Pandemic
Actual Study Start Date : March 23, 2019
Estimated Primary Completion Date : March 23, 2021
Estimated Study Completion Date : March 23, 2021

Group/Cohort Intervention/treatment
Hear and treat
phone call, treatment, not attended
See and treat
Ambulance crew attended
Other: attendance by ambulance crew
hear, attendance, convey




Primary Outcome Measures :
  1. Attendances for alcohol and drug use [ Time Frame: Full data set 23/03/2019 compared to 22/03/2021 to look at interruption (lockdown) in the time series. ]
    Counts of attendances for alcohol and drug use by the East Midland's Ambulance Service over the time period. This will be a number per day of people attended.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All people who ring 999 or 111 in an emergency.
Criteria

Inclusion Criteria:

  • Patient of any age
  • Patient requested ambulance attendance between 23rd March 2019 and 22nd March 2021
  • The patient record is held by East Midlands Ambulance Service
  • Patient records that have recorded a clinical impression related to alcohol and substance use will be included in the data set alongside a word search in the free text response box for the following words/phrases: narcotic, spice, mamba, alcohol, substance use, drug use, illicit drug, overdose, intoxication, intoxicated, drunk, high.

Exclusion Criteria:

  • The patient record was outside of the indicated date range.
  • The patient record is not accessible via EMAS

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04474444


Contacts
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Contact: Graham Law, PhD 07905008828 glaw@lincoln.ac.uk
Contact: Sam Lewis samlewis@lincoln.ac.uk

Locations
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United Kingdom
University of Lincoln Recruiting
Lincoln, United Kingdom, LN64PB
Contact: Graham Law, PhD    07905008828    glaw@lincoln.ac.uk   
Sponsors and Collaborators
University of Lincoln
Investigators
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Principal Investigator: Graham Law, PhD University of Lincoln
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Responsible Party: University of Lincoln
ClinicalTrials.gov Identifier: NCT04474444    
Other Study ID Numbers: ASAP01
First Posted: July 16, 2020    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share the IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergencies
Alcoholic Intoxication
Alcohol Drinking
Disease Attributes
Pathologic Processes
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders