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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04164940
Other study ID # ID734
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 23, 2019
Est. completion date December 2030

Study information

Verified date November 2023
Source Helse Stavanger HF
Contact Torgeir G Lid, MD PhD
Phone +47 48187477
Email torgeir.gilje.lid@sus.no
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Alcohol is contributing to many health problems and disorders, as well as accidents and social problems. Alcohol consumption has been on the rise the past 25 years, especially in Norway. The highest increase is found in older adults, in line with the development in most other countries in the western world. Older adults have a higher risk for alcohol related health problems, due to age related physiological changes, medical conditions and medications. Still, alcohol use is seldom addressed for older people. This means that older people rarely receive help to change alcohol habits. Norwegian health authorities have issued mandates ordering the regional health trusts to implement strategies in somatic hospital wards, mental health services and drug treatment services to identify and treat alcohol and drug problems affecting the patients' health. In this observational study we will explore patient trajectories three years prior to and three years after an admittance to hospital where risky or harmful alcohol consumption is identified and brief interventions are delivered. Hospitals that have implemented such strategies are invited to the study. Patient trajectories are studied in national health registries. This will provide important knowledge on what characterizes the patients identified, and what happens after they have received a brief intervention related to a hospital admittance.


Description:

This is a multi-centre registry study in Norwegian medical and surgical hospitals. The project is focusing on patients aged 60+, receiving an intervention for alcohol-related health problems in somatic hospital wards in one year, and without a previous history of referral or treatment in specialized health care for an alcohol or drug problem. Other age groups of adults will be used as control groups. The included patients will also be their own control group, where we compare registry data on the trajectories three years following the alcohol intervention with registry data from the three years preceding the intervention. The recruited hospitals will have different strategies for identification of and interventions for alcohol-related health problems, and the choice of methods is thus outside of our control. All inhabitants in Norway are registered with a personal identification number. This individual identifier makes the linkage between the participants and the different registries possible. Data from these registries will enable the study of serious incidents, as well as of diagnoses, medications and other treatments, welfare and benefits, and causes of death. Data will be gathered three years retrospectively and 3 years prospectively, related to the index hospital stay where alcohol is addressed and a brief intervention is delivered. Inclusion criteria for patients are age 21+, no previous treatment history for drug or alcohol problems in specialized health care, admitted to medical or surgical hospital ward, identified risky or harmful alcohol consumption, accepting an alcohol intervention and accepting study participation. Baseline data collected are AUDIT C, question no 10 from the full AUDIT and classification of alcohol consumption (risky or harmful). All other variables are extracted from the national health registries (reimbursement data from primary health care and secondary health care, prescription database, Cause of death registry, Norwegian Trauma Registry and social security data, marital status, professional status).


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 2030
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria: - Age 21 or older, no previous alcohol use disorder or substance use disorder, admitted to hospital which has implemented screening and brief alcohol intervention strategies, written consent to participate Exclusion Criteria: - specialized treatment for alcohol use disorder og drug use disorder during the three years prior to recruitment

Study Design


Intervention

Other:
Brief alcohol intervention
Brief alcohol intervention already implemented in daily routine by the individual hospitals.

Locations

Country Name City State
Norway StavangerUH Stavanger

Sponsors (9)

Lead Sponsor Collaborator
Helse Stavanger HF Helse Fonna, Helse Møre og Romsdal HF, Helse Sor-Ost, Helse Vest, Lovisenberg Diakonale Hospital, Oslo University Hospital, Sorlandet Hospital HF, Vestre Viken Hospital Trust

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Alcohol use disorder (AUD) Diagnosis of AUD after recruitment in the study Three years
Primary Prescriptions for AUD Prescriptions for the treatment of alcohol use disorder Three years
Secondary Health care Diagnoses and procedures in primary and secondary health care Three years
Secondary Trauma Serious trauma registered in trauma registry Three years
Secondary Death Death and cause of death Three years
Secondary Prescriptions for addictive drugs Prescriptions for any drug with addictive potential Three years
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