Impact of Alcohol Consumption on Use of Health Care Resources

• ClinicalTrials.gov Identifier: NCT02343874
• Recruitment Status: Completed
• First Posted: January 22, 2015
• Last Update Posted: January 22, 2015
• Sponsor: Hospital Clinic of Barcelona
• Collaborators: Institut Catala de Salut; Institut Català de la Salut; Public Health Agency of Barcelona; Lundbeck Foundation
• Information provided by (Responsible Party): Antoni Gual, Hospital Clinic of Barcelona

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Alcohol Consumption	Other: No intervention

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

• Study Type: Observational
• Actual Enrollment: 1911771 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• 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.
• Study Start Date: December 2012
• Actual Primary Completion Date: December 2012
• Actual Study Completion Date: December 2013

Groups and Cohorts

Group/Cohort	Intervention/treatment
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	Other: No intervention; No intervention will be done. The exposure of interest in this study is alcohol consumption in patients attended in primary health.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. sick-leave costs [ Time Frame: 1 year ]
   sick leave costs (euros per individual)

Secondary Outcome Measures :

1. Primary health care costs [ Time Frame: 1 year ]
   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)
2. laboratory costs [ Time Frame: 1 year ]
   Association between alcohol consumption and laboratory costs (euros per individual)
3. Pharmacy expenses [ Time Frame: 1 year ]
   Association between alcohol consumption and pharmacy expenses (euros per individual)
4. Inpatient costs [ Time Frame: 1 year ]
   Association between alcohol consumption and inpatient costs which include: Inpatients costs from General hospitals, Psychiatric hospitals or rehabilitation hospitals (euros per individual)
5. costs due to emergency attendance [ Time Frame: 1 year ]
   Association between alcohol consumption and costs due to the emergency room attendance (euros per individual)
6. outpatient mental health costs [ Time Frame: 1 year ]
   Association between alcohol consumption and outpatients mental health costs (euros per individual).
7. specialists consults costs [ Time Frame: 1 year ]
   Association between alcohol consumption and costs due to specialists consults
8. Primary health visits [ Time Frame: 1 year ]
   Association between alcohol consumption and the number of appointments with the general practitioner, nurse or social worker
9. Admissions in hospital [ Time Frame: 1 year ]
   Association between alcohol consumption and the number of hospital admissions (general hospital, mental health and rehabilitation hospitals)
10. days of stay in hospital [ Time Frame: 1year ]
    Association between alcohol consumption and the number of days of stay in hospitals (General Hospital, Psychiatric Hospital or Rehabilitation hospital)
11. emergency contacts [ Time Frame: 1 year ]
    Association between alcohol consumption and the number of emergency visits.
12. specialists appointments [ Time Frame: 1 year ]
    Association between alcohol consumption and the number of visits done with a specialist.
13. Hospital admissions causes [ Time Frame: 1 year ]
    Number of hospital admissions depending on the cause (wholly attributable to alcohol, partly attributable- acute, partly attributed-chronic or not related with alcohol consumption)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Patients over 17 years old attended in the primary health care setting that have their alcohol consumption registered in the medical record.

Criteria

Inclusion Criteria:

• Patients over 17 years old
• Patients with alcohol consumption registered in the medical record

Exclusion Criteria:

• patients <= 17 years old.

Contacts and Locations

Locations

Spain

Hospital Clínic de Barcelona

Barcelona, Spain, 08036

Sponsors and Collaborators

Hospital Clinic of Barcelona

Institut Catala de Salut

Institut Català de la Salut

Public Health Agency of Barcelona

Lundbeck Foundation

Investigators

• Principal Investigator: Antoni Gual, PhD; Institut d'investigacions Biomèdiques Agust Pi i Sunyer (IDIBAPS)

More Information

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• Responsible Party: Antoni Gual, Senior consultant, Hospital Clinic of Barcelona
• ClinicalTrials.gov Identifier: NCT02343874
• Other Study ID Numbers: 2013/8739
• First Posted: January 22, 2015
• Last Update Posted: January 22, 2015
• Last Verified: January 2015

Keywords provided by Antoni Gual, Hospital Clinic of Barcelona:

Alcohol consumption; Primary health care; health care costs; health service utilization

Additional relevant MeSH terms:

Alcohol Drinking; Drinking Behavior