- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04474444
Ambulance Calls for Substance Use and Alcohol in a Pandemic (ASAP) (ASAP)
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Lincoln, United Kingdom, LN64PB
- University of Lincoln
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Hear and treat
phone call, treatment, not attended
|
|
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See and treat
Ambulance crew attended
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hear, attendance, convey
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Full data set 23/03/2019 compared to 22/03/2021 to look at interruption (lockdown) in the time series.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Graham Law, PhD, University of Lincoln
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Disease Attributes
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Chemically-Induced Disorders
- Drinking Behavior
- Alcohol-Related Disorders
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- COVID-19
- Emergencies
- Alcohol Drinking
- Substance-Related Disorders
- Alcoholic Intoxication
Other Study ID Numbers
- ASAP01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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