NCT02343874

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,911,771

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 22, 2015

Completed
Last Updated

January 22, 2015

Status Verified

January 1, 2015

Enrollment Period

Same day

First QC Date

January 13, 2015

Last Update Submit

January 16, 2015

Conditions

Keywords

Alcohol consumptionPrimary health carehealth care costshealth service utilization

Outcome Measures

Primary Outcomes (2)

  • 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

  • sick-leave costs

    sick leave costs (euros per individual)

    1 year

Secondary Outcomes (13)

  • Primary health care costs

    1 year

  • laboratory costs

    1 year

  • Pharmacy expenses

    1 year

  • Inpatient costs

    1 year

  • costs due to emergency attendance

    1 year

  • +8 more secondary outcomes

Study Arms (1)

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

Interventions

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

Alcohol consumption

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • patients \<= 17 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Related Publications (19)

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MeSH Terms

Conditions

Alcohol DrinkingPatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Antoni Gual, PhD

    Institut d'investigacions Biomèdiques Agust Pi i Sunyer (IDIBAPS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior consultant

Study Record Dates

First Submitted

January 13, 2015

First Posted

January 22, 2015

Study Start

December 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2013

Last Updated

January 22, 2015

Record last verified: 2015-01

Locations