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).