Alcohol Use, UnspecifiedASAPNCT04474444
Ambulance Calls for Substance Use and Alcohol in a Pandemic (ASAP)
An observational study of Alcohol Use, Unspecified and Substance Use, run by University of Lincoln at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use, Unspecified, Substance Use, Intoxication Alcohol
- What is being tested?
- attendance by ambulance crew
- How many people
- 55,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Mar 2019to 23 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All people who ring 999 or 111 in an emergency.
Who may be able to join
- 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.
Who cannot join
- The patient record was outside of the indicated date range.
- The patient record is not accessible via EMAS
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Alcohol Use, Unspecified, Substance Use, Intoxication Alcohol, Emergencies, COVID-19 Pandemic, Treatment
- Being tested
- attendance by ambulance crew
- Medical subject headings
- Alcohol Drinking, Substance-Related Disorders, Alcoholic Intoxication, Emergencies, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
attendance by ambulance crewOther
hear, attendance, convey
| Study group | Role | What they receive |
|---|---|---|
| Hear and treat | phone call, treatment, not attended | |
| See and treat | Ambulance crew attended Receives: Other: attendance by ambulance crew |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendances for alcohol and drug use
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.
Measured: Full data set 23/03/2019 compared to 22/03/2021 to look at interruption (lockdown) in the time series.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start23 Mar 2019
- Primary completion23 Mar 2021
- Study completion23 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use, UnspecifiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 55,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lincoln
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Graham Law, PhD, Principal investigator, University of Lincoln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474444
- Sponsor's protocol ID
- ASAP01
- Acronym
- ASAP
- Status last verified
- Jul 2020
- First submitted
- 12 Jul 2020
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share the IPD
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04474444
- Acronym / sponsor ID
- ASAP / ASAP01
- Conditions
- Alcohol Use, Unspecified, Substance Use, Intoxication Alcohol, Emergencies, COVID-19 Pandemic, Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55,000 participants (actual)
- Lead sponsor
- University of LincolnUniversity, hospital or other
- Study start
- 23 Mar 2019 (actual)
- Primary completion
- 23 Mar 2021 (actual)
- Study completion
- 23 Mar 2021 (actual)
- First posted
- 16 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hear and treat | – | –phone call, treatment, not attended |
| See and treat | – | Other: attendance by ambulance crewAmbulance crew attended |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All people who ring 999 or 111 in an emergency.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- The patient record was outside of the indicated date range.
- The patient record is not accessible via EMAS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| attendance by ambulance crewhear, attendance, convey | Other | See and treat |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No. There is no plan to share the IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graham Law, PhD principal investigator
University of Lincoln
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Use, Unspecified and Substance Use, run by University of Lincoln at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.