Impact of Alcohol Consumption on Use of Health Care Resources

Alcohol Consumption Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02343874
• Other study ID #: 2013/8739
• Status: Completed
• Phase: N/A
• First received: January 13, 2015
• Last updated: January 16, 2015
• Start date: December 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2015
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1911771
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over 17 years old

• Patients with alcohol consumption registered in the medical record

Exclusion Criteria:

• patients <= 17 years old.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Alcohol Consumption
• Alcohol Drinking

Intervention

Other:
• No intervention
No intervention will be done. The exposure of interest in this study is alcohol consumption in patients attended in primary health.

Locations

Country	Name	City	State
Spain	Hospital Clínic de Barcelona	Barcelona

Sponsors (5)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Agencia de Salut Pública de Barcelona. Direcció de Drogodependències. Generalitat de Catalunya, Institut Català de la Salut, Institut Catala de Salut, Lundbeck Foundation

Country where clinical trial is conducted

Spain, 

References & Publications (19)

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* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year	No
Primary	sick-leave costs	sick leave costs (euros per individual)	1 year	No
Secondary	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)	1 year	No
Secondary	laboratory costs	Association between alcohol consumption and laboratory costs (euros per individual)	1 year	No
Secondary	Pharmacy expenses	Association between alcohol consumption and pharmacy expenses (euros per individual)	1 year	No
Secondary	Inpatient costs	Association between alcohol consumption and inpatient costs which include: Inpatients costs from General hospitals, Psychiatric hospitals or rehabilitation hospitals (euros per individual)	1 year	No
Secondary	costs due to emergency attendance	Association between alcohol consumption and costs due to the emergency room attendance (euros per individual)	1 year	No
Secondary	outpatient mental health costs	Association between alcohol consumption and outpatients mental health costs (euros per individual).	1 year	No
Secondary	specialists consults costs	Association between alcohol consumption and costs due to specialists consults	1 year	No
Secondary	Primary health visits	Association between alcohol consumption and the number of appointments with the general practitioner, nurse or social worker	1 year	No
Secondary	Admissions in hospital	Association between alcohol consumption and the number of hospital admissions (general hospital, mental health and rehabilitation hospitals)	1 year	No
Secondary	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)	1year	No
Secondary	emergency contacts	Association between alcohol consumption and the number of emergency visits.	1 year	No
Secondary	specialists appointments	Association between alcohol consumption and the number of visits done with a specialist.	1 year	No
Secondary	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)	1 year	No