Alcohol ConsumptionNCT02343874
Impact of Alcohol Consumption on Use of Health Care Resources
An observational study of Alcohol Consumption, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The prevalence of alcohol-related disorders in the general population is around 10%. The relationship between the use of healthcare services, costs and the amount of alcohol consumed by the general population is unknown. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Consumption
- How many people
- 1,911,771 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2012to Dec 2013
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients over 17 years old attended in the primary health care setting that have their alcohol consumption registered in the medical record.
Who may be able to join
- Patients over 17 years old
- Patients with alcohol consumption registered in the medical record
Who cannot join
- patients <= 17 years old.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Alcohol Consumption of the General Population Who Visited Primary Health Care Centers on the Use of Health Care Resources in Catalonia.
The prevalence of alcohol-related disorders in the general population is around 10%. The relationship between the use of healthcare services, costs and the amount of alcohol consumed by the general population is unknown. Because alcoholism is a major public health problem, it is significant to determine the prevalence of consumption of primary users and the relationship between the dose of alcohol and health care costs. This information may allow the implementation of preventive strategies to reduce consumption with the aim to reduce morbidity and healthcare expenditure.
A cross-sectional study will be carried out. Patients over 17 years old, treated at primary healthcare centers in Catalonia that have available data on alcohol consumption from January 2010 to December 2012 will be included. Clinical and sociodemographic data will be collected. Health service use and health care costs from 2013 will be collected from SIDIAP (The Information System for the Development of Research in Primary Care) database.
A positive relationship between grams of alcohol consumed per week and the use of resources and health expenditure will be expected and also the level of risk of alcohol consumption. There will be a descriptive analysis of the clinical data and sociodemographic variables. A multivariate analysis will be done to see the relationship between alcohol consumption and health care costs and health care service utilization.
Read the detailed description
The aim of the study is to describe the association between alcohol consumption and the use of health care resources and the health care costs in Catalonia, which is a region of Spain.
A cross-sectional study was done. Patients recruited in the study were those attended in the primary health care whose alcohol consumption was registered in the electronic medical record between 1st of January 2011 to 31st of December 2012. At Baseline (31st of December 2012), sociodemographic data and clinical data was recorded, and health care utilization and costs were obtained from year 2013.
Two different registers were used for sociodemographic, clinical and health service utilization indicators and costs. Information on life style factors (alcohol and tobacco consumption, body mass index), demographic information like the ecologic MEDEA index, and sick-leave costs were obtained from the Information System for the Development of Research in Primary Care (SIDIAP) database. This clinical database has anonymized records of almost the 80% of the Catalan population. General practitioners can record alcohol consumption in two different ways (quantitative and categorical information). A quantitative variable defined as grams of alcohol per week and a categorical variable measuring the risk of alcohol consumption (none, low risk, risky drinker). The type of risk was defined as follows (No drinker; Low drinker (men who drinks <280g per week of alcohol or women who drinks <179g per week); Riky drinker (men who drinks >=280g per week or women who drinks >=170g per week of alcohol, or men who drinks more than 5 drinks per occasion, women who drinks more than 4 drinks per occasion; men who drinks <280g per week of alcohol or women who drinks <179g per week and at the same time work with heavy machinery or are taking medication that could interfere with alcohol)).
Sociodemographic data (age and sex and socioeconomic status) and clinical data (hypertension, diabetes, hyperlipemia, obesity, psychiatric diseases, clinical risk groups and diagnosis wholly attributable and partly attributable to alcohol) were obtained from the central register (Morbidity Register) provided by the Catalan Health service. From the same register data on health service utilization was collected. These indicators include: the number and costs of outpatients visits from doctor, nurse and social worker in primary health centres; hospital admissions, emergency room visits, mental health outpatients visits, and specialists referrals. Data on acute and chronic hospitalizations were analysed using three indicators: costs, number of admissions and hospital days, defined as the number of days stayed in any hospital. Three types of hospitals were included in the administrative system: general (acute) hospital, rehabilitation hospital and psychiatric hospital. The patient's diagnosis at admission was also registered. Using the same categories as Jones and colleagues, we distinguished between entry diagnosis wholly attributable to alcohol (e.g., alcohol dependence or alcoholic liver cirrhosis), entry diagnosis partly attributable (acute and chronic), or not related to alcohol. Also information about medication expenses and seak-leave costs were included.
Quality checks, in SIDIAP database, to identify duplicate patient identification are performed centrally at the time of each SIDIAP database update. Furthermore, checks for logic values are performed and unexpected values are dismissed. A part from that, a number of papers have been published on the validity of SIDIAP coding for various conditions. The quality and consistency of the central Catalan register is very good with a built-in validation to detect problems and inconsistencies between variables. In addition, the system is periodically externally validated to ensure quality of data, as these data are used to control payment to service providers.
Descriptive analyses of sociodemographic and clinical data will be carried out. Analysis of variance (ANOVA) and t-students tests will be used to compare continuous data, and chi-square analysis for categorical variables. Bonferroni correction will be used for multiple comparisons. A probability level of 5% or less will be considered as statistically significant. Poisson regression and sensitivity analyses with negative binomial regression will be done. Linear regression will be done to analyze the relationship between grams per week of alcohol and health costs. Data were analysed with Statistical Analysis Software.
- Conditions
- Alcohol Consumption
- Being tested
- No intervention
- Keywords
- Alcohol consumption, Primary health care, health care costs, health service utilization
- Medical subject headings
- Alcohol Drinking, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention will be done. The exposure of interest in this study is alcohol consumption in patients attended in primary health.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol consumption | Patients over 17 years old with alcohol consumption registered in the electronic medical record (31st December 2012).
No intervention is going to be administered but exposure to alcohol will be analysed Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health economic costs (composite measure)
Association between alcohol consumption and Health economic costs (euros per individual) which include the sum of the following costs: primary health costs (appointments with the doctor, nurse or social worker), laboratory costs, pharmacy expenses, Inpatients costs from General hospitals, Psychiatric hospitals or rehabilitation hospitals, costs due to emergency visits, costs of outpatient visits in mental health and costs due to appointments with specialists.
Measured: 1 year
sick-leave costs
sick leave costs (euros per individual)
Measured: 1 year
Secondary outcomes (13)
Primary health care costs
Association between alcohol consumption and primary health care costs which include costs due to the patients appointments with the doctor, nurse or social worker (euros per individual)
Measured: 1 year
laboratory costs
Association between alcohol consumption and laboratory costs (euros per individual)
Measured: 1 year
Pharmacy expenses
Association between alcohol consumption and pharmacy expenses (euros per individual)
Measured: 1 year
Inpatient costs
Association between alcohol consumption and inpatient costs which include: Inpatients costs from General hospitals, Psychiatric hospitals or rehabilitation hospitals (euros per individual)
Measured: 1 year
costs due to emergency attendance
Association between alcohol consumption and costs due to the emergency room attendance (euros per individual)
Measured: 1 year
outpatient mental health costs
Association between alcohol consumption and outpatients mental health costs (euros per individual).
Measured: 1 year
specialists consults costs
Association between alcohol consumption and costs due to specialists consults
Measured: 1 year
Primary health visits
Association between alcohol consumption and the number of appointments with the general practitioner, nurse or social worker
Measured: 1 year
Admissions in hospital
Association between alcohol consumption and the number of hospital admissions (general hospital, mental health and rehabilitation hospitals)
Measured: 1 year
days of stay in hospital
Association between alcohol consumption and the number of days of stay in hospitals (General Hospital, Psychiatric Hospital or Rehabilitation hospital)
Measured: 1year
emergency contacts
Association between alcohol consumption and the number of emergency visits.
Measured: 1 year
specialists appointments
Association between alcohol consumption and the number of visits done with a specialist.
Measured: 1 year
Hospital admissions causes
Number of hospital admissions depending on the cause (wholly attributable to alcohol, partly attributable- acute, partly attributed-chronic or not related with alcohol consumption)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2015 (estimated)
- Study startDec 2012
- Primary completionDec 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,911,771 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Catala de Salut, Institut Català de la Salut, Public Health Agency of Barcelona, Lundbeck Foundation
- Responsible party
- Principal investigator, Antoni Gual, Hospital Clinic of Barcelona
- Investigators
- Antoni Gual, PhD, Principal investigator, Institut d'investigacions Biomèdiques Agust Pi i Sunyer (IDIBAPS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02343874
- Sponsor's protocol ID
- 2013/8739
- Status last verified
- Jan 2015
- First submitted
- 13 Jan 2015
- Last updated
- 22 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Anderson P, Cremona A, Paton A, Turner C, Wallace P. The risk of alcohol. Addiction. 1993 Nov;88(11):1493-508. doi: 10.1111/j.1360-0443.1993.tb03135.x.
PubMed 8286995Compton WM, Thomas YF, Stinson FS, Grant BF. Prevalence, correlates, disability, and comorbidity of DSM-IV drug abuse and dependence in the United States: results from the national epidemiologic survey on alcohol and related conditions. Arch Gen Psychiatry. 2007 May;64(5):566-76. doi: 10.1001/archpsyc.64.5.566.
PubMed 17485608Laramee P, Kusel J, Leonard S, Aubin HJ, Francois C, Daeppen JB. The economic burden of alcohol dependence in Europe. Alcohol Alcohol. 2013 May-Jun;48(3):259-69. doi: 10.1093/alcalc/agt004. Epub 2013 Jan 30.
PubMed 23371284Rehm J, Giesbrecht N, Patra J, Roerecke M. Estimating chronic disease deaths and hospitalizations due to alcohol use in Canada in 2002: implications for policy and prevention strategies. Prev Chronic Dis. 2006 Oct;3(4):A121. Epub 2006 Sep 15.
PubMed 16978496Gual A, Lligona A, Costa S, Segura L, Colom J. [Long term impact of treatment in alcoholics. Results from a 10-year longitudinal follow-up study of 850 patients]. Med Clin (Barc). 2004 Sep 25;123(10):364-9. doi: 10.1016/s0025-7753(04)74520-0. Spanish.
PubMed 15482699Gual A, Bravo F, Lligona A, Colom J. Treatment for alcohol dependence in Catalonia: health outcomes and stability of drinking patterns over 20 years in 850 patients. Alcohol Alcohol. 2009 Jul-Aug;44(4):409-15. doi: 10.1093/alcalc/agp032. Epub 2009 Jun 2.
PubMed 19491281Geary T, O'Brien P, Ramsay S, Cook B; Scottish Intensive Care Trainees' Audit Share Group. A national service evaluation of the impact of alcohol on admissions to Scottish intensive care units. Anaesthesia. 2012 Oct;67(10):1132-7. doi: 10.1111/j.1365-2044.2012.07233.x. Epub 2012 Jul 16.
PubMed 22804562Lawder R, Grant I, Storey C, Walsh D, Whyte B, Hanlon P. Epidemiology of hospitalization due to alcohol-related harm: evidence from a Scottish cohort study. Public Health. 2011 Aug;125(8):533-9. doi: 10.1016/j.puhe.2011.05.007. Epub 2011 Jul 26.
PubMed 21794884Taylor B, Rehm J, Patra J, Popova S, Baliunas D. Alcohol-attributable morbidity and resulting health care costs in Canada in 2002: recommendations for policy and prevention. J Stud Alcohol Drugs. 2007 Jan;68(1):36-47. doi: 10.15288/jsad.2007.68.36.
PubMed 17149516McKenny M, O'Beirne S, Fagan C, O'Connell M. Alcohol-related admissions to an intensive care unit in Dublin. Ir J Med Sci. 2010 Sep;179(3):405-8. doi: 10.1007/s11845-010-0498-y. Epub 2010 May 28.
PubMed 20509003Corrao G, Bagnardi V, Zambon A, Arico S. Exploring the dose-response relationship between alcohol consumption and the risk of several alcohol-related conditions: a meta-analysis. Addiction. 1999 Oct;94(10):1551-73. doi: 10.1046/j.1360-0443.1999.9410155111.x.
PubMed 10790907Hvidtfeldt UA, Rasmussen S, Gronbaek M, Becker U, Tolstrup JS. Influence of smoking and alcohol consumption on admissions and duration of hospitalization. Eur J Public Health. 2010 Aug;20(4):376-82. doi: 10.1093/eurpub/ckp153. Epub 2009 Sep 30.
PubMed 19793836Cohen E, Feinn R, Arias A, Kranzler HR. Alcohol treatment utilization: findings from the National Epidemiologic Survey on Alcohol and Related Conditions. Drug Alcohol Depend. 2007 Jan 12;86(2-3):214-21. doi: 10.1016/j.drugalcdep.2006.06.008. Epub 2006 Aug 17.
PubMed 16919401Baser O, Chalk M, Rawson R, Gastfriend DR. Alcohol dependence treatments: comprehensive healthcare costs, utilization outcomes, and pharmacotherapy persistence. Am J Manag Care. 2011 Jun;17 Suppl 8:S222-34.
PubMed 21761948Bray JW, Cowell AJ, Hinde JM. A systematic review and meta-analysis of health care utilization outcomes in alcohol screening and brief intervention trials. Med Care. 2011 Mar;49(3):287-94. doi: 10.1097/MLR.0b013e318203624f.
PubMed 21263359
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Alcohol Consumption of the General Population Who Visited Primary Health Care Centers on the Use of Health Care Resources in Catalonia.
- ClinicalTrials.gov ID
- NCT02343874
- Acronym / sponsor ID
- 2013/8739
- Conditions
- Alcohol Consumption
- Keywords
- Alcohol consumption, Primary health care, health care costs, health service utilization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,911,771 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Institut Catala de Salut, Institut Català de la Salut, Public Health Agency of Barcelona, Lundbeck Foundation
- Study start
- Dec 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 22 Jan 2015 (estimated)
- 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 prevalence of alcohol-related disorders in the general population is around 10%. The relationship between the use of healthcare services, costs and the amount of alcohol consumed by the general population is unknown. Because alcoholism is a major public health problem, it is significant to determine the prevalence of consumption of primary users and the relationship between the dose of alcohol and health care costs. This information may allow the implementation of preventive strategies to reduce consumption with the aim to reduce morbidity and healthcare expenditure.
A cross-sectional study will be carried out. Patients over 17 years old, treated at primary healthcare centers in Catalonia that have available data on alcohol consumption from January 2010 to December 2012 will be included. Clinical and sociodemographic data will be collected. Health service use and health care costs from 2013 will be collected from SIDIAP (The Information System for the Development of Research in Primary Care) database.
A positive relationship between grams of alcohol consumed per week and the use of resources and health expenditure will be expected and also the level of risk of alcohol consumption. There will be a descriptive analysis of the clinical data and sociodemographic variables. A multivariate analysis will be done to see the relationship between alcohol consumption and health care costs and health care service utilization.
Detailed description
The aim of the study is to describe the association between alcohol consumption and the use of health care resources and the health care costs in Catalonia, which is a region of Spain.
A cross-sectional study was done. Patients recruited in the study were those attended in the primary health care whose alcohol consumption was registered in the electronic medical record between 1st of January 2011 to 31st of December 2012. At Baseline (31st of December 2012), sociodemographic data and clinical data was recorded, and health care utilization and costs were obtained from year 2013.
Two different registers were used for sociodemographic, clinical and health service utilization indicators and costs. Information on life style factors (alcohol and tobacco consumption, body mass index), demographic information like the ecologic MEDEA index, and sick-leave costs were obtained from the Information System for the Development of Research in Primary Care (SIDIAP) database. This clinical database has anonymized records of almost the 80% of the Catalan population. General practitioners can record alcohol consumption in two different ways (quantitative and categorical information). A quantitative variable defined as grams of alcohol per week and a categorical variable measuring the risk of alcohol consumption (none, low risk, risky drinker). The type of risk was defined as follows (No drinker; Low drinker (men who drinks <280g per week of alcohol or women who drinks <179g per week); Riky drinker (men who drinks >=280g per week or women who drinks >=170g per week of alcohol, or men who drinks more than 5 drinks per occasion, women who drinks more than 4 drinks per occasion; men who drinks <280g per week of alcohol or women who drinks <179g per week and at the same time work with heavy machinery or are taking medication that could interfere with alcohol)).
Sociodemographic data (age and sex and socioeconomic status) and clinical data (hypertension, diabetes, hyperlipemia, obesity, psychiatric diseases, clinical risk groups and diagnosis wholly attributable and partly attributable to alcohol) were obtained from the central register (Morbidity Register) provided by the Catalan Health service. From the same register data on health service utilization was collected. These indicators include: the number and costs of outpatients visits from doctor, nurse and social worker in primary health centres; hospital admissions, emergency room visits, mental health outpatients visits, and specialists referrals. Data on acute and chronic hospitalizations were analysed using three indicators: costs, number of admissions and hospital days, defined as the number of days stayed in any hospital. Three types of hospitals were included in the administrative system: general (acute) hospital, rehabilitation hospital and psychiatric hospital. The patient's diagnosis at admission was also registered. Using the same categories as Jones and colleagues, we distinguished between entry diagnosis wholly attributable to alcohol (e.g., alcohol dependence or alcoholic liver cirrhosis), entry diagnosis partly attributable (acute and chronic), or not related to alcohol. Also information about medication expenses and seak-leave costs were included.
Quality checks, in SIDIAP database, to identify duplicate patient identification are performed centrally at the time of each SIDIAP database update. Furthermore, checks for logic values are performed and unexpected values are dismissed. A part from that, a number of papers have been published on the validity of SIDIAP coding for various conditions. The quality and consistency of the central Catalan register is very good with a built-in validation to detect problems and inconsistencies between variables. In addition, the system is periodically externally validated to ensure quality of data, as these data are used to control payment to service providers.
Descriptive analyses of sociodemographic and clinical data will be carried out. Analysis of variance (ANOVA) and t-students tests will be used to compare continuous data, and chi-square analysis for categorical variables. Bonferroni correction will be used for multiple comparisons. A probability level of 5% or less will be considered as statistically significant. Poisson regression and sensitivity analyses with negative binomial regression will be done. Linear regression will be done to analyze the relationship between grams per week of alcohol and health costs. Data were analysed with Statistical Analysis Software.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alcohol consumption | – | Other: No interventionPatients over 17 years old with alcohol consumption registered in the electronic medical record (31st December 2012). No intervention is going to be administered but exposure to alcohol will be analysed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 17 years old attended in the primary health care setting that have their alcohol consumption registered in the medical record.
Key inclusion criteria (2 listed)
- Patients over 17 years old
- Patients with alcohol consumption registered in the medical record
Key exclusion criteria (1 listed)
- patients <= 17 years old.
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 |
|---|---|---|
| No interventionNo intervention will be done. The exposure of interest in this study is alcohol consumption in patients attended in primary health. | Other | Alcohol consumption |
Primary outcome
Health economic costs (composite measure)
Time frame: 1 year
Association between alcohol consumption and Health economic costs (euros per individual) which include the sum of the following costs: primary health costs (appointments with the doctor, nurse or social worker), laboratory costs, pharmacy expenses, Inpatients costs from General hospitals, Psychiatric hospitals or rehabilitation hospitals, costs due to emergency visits, costs of outpatient visits in mental health and costs due to appointments with specialists.
sick-leave costs
Time frame: 1 year
sick leave costs (euros per individual)
13 secondary outcomes
Primary health care costs
Time frame: 1 year
laboratory costs
Time frame: 1 year
Pharmacy expenses
Time frame: 1 year
Inpatient costs
Time frame: 1 year
costs due to emergency attendance
Time frame: 1 year
outpatient mental health costs
Time frame: 1 year
specialists consults costs
Time frame: 1 year
Primary health visits
Time frame: 1 year
Admissions in hospital
Time frame: 1 year
days of stay in hospital
Time frame: 1year
emergency contacts
Time frame: 1 year
specialists appointments
Time frame: 1 year
Hospital admissions causes
Time frame: 1 year
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 22 Jan 2015.
- Background: PubMed 8286995Anderson P, Cremona A, Paton A, Turner C, Wallace P. The risk of alcohol. Addiction. 1993 Nov;88(11):1493-508. doi: 10.1111/j.1360-0443.1993.tb03135.x.
- Background: PubMed 17485608Compton WM, Thomas YF, Stinson FS, Grant BF. Prevalence, correlates, disability, and comorbidity of DSM-IV drug abuse and dependence in the United States: results from the national epidemiologic survey on alcohol and related conditions. Arch Gen Psychiatry. 2007 May;64(5):566-76. doi: 10.1001/archpsyc.64.5.566.
- Background: PubMed 23371284Laramee P, Kusel J, Leonard S, Aubin HJ, Francois C, Daeppen JB. The economic burden of alcohol dependence in Europe. Alcohol Alcohol. 2013 May-Jun;48(3):259-69. doi: 10.1093/alcalc/agt004. Epub 2013 Jan 30.
- Background: PubMed 16978496Rehm J, Giesbrecht N, Patra J, Roerecke M. Estimating chronic disease deaths and hospitalizations due to alcohol use in Canada in 2002: implications for policy and prevention strategies. Prev Chronic Dis. 2006 Oct;3(4):A121. Epub 2006 Sep 15.
- Background: PubMed 15482699Gual A, Lligona A, Costa S, Segura L, Colom J. [Long term impact of treatment in alcoholics. Results from a 10-year longitudinal follow-up study of 850 patients]. Med Clin (Barc). 2004 Sep 25;123(10):364-9. doi: 10.1016/s0025-7753(04)74520-0. Spanish.
- Background: PubMed 19491281Gual A, Bravo F, Lligona A, Colom J. Treatment for alcohol dependence in Catalonia: health outcomes and stability of drinking patterns over 20 years in 850 patients. Alcohol Alcohol. 2009 Jul-Aug;44(4):409-15. doi: 10.1093/alcalc/agp032. Epub 2009 Jun 2.
- Background: PubMed 22804562Geary T, O'Brien P, Ramsay S, Cook B; Scottish Intensive Care Trainees' Audit Share Group. A national service evaluation of the impact of alcohol on admissions to Scottish intensive care units. Anaesthesia. 2012 Oct;67(10):1132-7. doi: 10.1111/j.1365-2044.2012.07233.x. Epub 2012 Jul 16.
- Background: PubMed 21794884Lawder R, Grant I, Storey C, Walsh D, Whyte B, Hanlon P. Epidemiology of hospitalization due to alcohol-related harm: evidence from a Scottish cohort study. Public Health. 2011 Aug;125(8):533-9. doi: 10.1016/j.puhe.2011.05.007. Epub 2011 Jul 26.
- Background: PubMed 17149516Taylor B, Rehm J, Patra J, Popova S, Baliunas D. Alcohol-attributable morbidity and resulting health care costs in Canada in 2002: recommendations for policy and prevention. J Stud Alcohol Drugs. 2007 Jan;68(1):36-47. doi: 10.15288/jsad.2007.68.36.
- Background: PubMed 20509003McKenny M, O'Beirne S, Fagan C, O'Connell M. Alcohol-related admissions to an intensive care unit in Dublin. Ir J Med Sci. 2010 Sep;179(3):405-8. doi: 10.1007/s11845-010-0498-y. Epub 2010 May 28.
- Background: PubMed 10790907Corrao G, Bagnardi V, Zambon A, Arico S. Exploring the dose-response relationship between alcohol consumption and the risk of several alcohol-related conditions: a meta-analysis. Addiction. 1999 Oct;94(10):1551-73. doi: 10.1046/j.1360-0443.1999.9410155111.x.
- Background: PubMed 19793836Hvidtfeldt UA, Rasmussen S, Gronbaek M, Becker U, Tolstrup JS. Influence of smoking and alcohol consumption on admissions and duration of hospitalization. Eur J Public Health. 2010 Aug;20(4):376-82. doi: 10.1093/eurpub/ckp153. Epub 2009 Sep 30.
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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.
Antoni Gual, PhD principal investigator
Institut d'investigacions Biomèdiques Agust Pi i Sunyer (IDIBAPS)
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 Consumption, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 2 inclusion and 1 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 22 Jan 2015. 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 Spain. 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?
Health economic costs (composite measure) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02343874, which also lists 19 linked publications.
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 22 Jan 2015.