- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04164940
Patient Trajectories for Older Adults Admitted to Hospital for Alcohol-related Problems
A Multi-centre Registry Study on Patient Trajectories After Interventions for Alcohol-related Health Problems in Somatic Hospital Wards, for People in Late Adulthood (60+)
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.
Study Overview
Status
Intervention / Treatment
Detailed 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).
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Torgeir G Lid, MD PhD
- Phone Number: +47 48187477
- Email: torgeir.gilje.lid@sus.no
Study Contact Backup
- Name: Sverre M Nesvaag, Dr Philos
- Phone Number: +47 90837431
- Email: sverre.martin.nesvaag@sus.no
Study Locations
-
-
-
Stavanger, Norway, 4068
- Recruiting
- StavangerUH
-
Contact:
- Torgeir G Lid, MD PhD
- Phone Number: +4748187477
- Email: torgeir.gilje.lid@sus.no
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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:
- previous alcohol use disorder og drug use disorder
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Age 21-30
Patients aged 21-30 when admitted to hospital and receiving brief alcohol intervention
|
Brief alcohol intervention already implemented in daily routine by the individual hospitals.
|
|
Age 31-40
Patients aged 31-40 when admitted to hospital and receiving brief alcohol intervention
|
Brief alcohol intervention already implemented in daily routine by the individual hospitals.
|
|
Age 41-50
Patients aged 41-50 when admitted to hospital and receiving brief alcohol intervention
|
Brief alcohol intervention already implemented in daily routine by the individual hospitals.
|
|
Age 51-60
Patients aged 51-60 when admitted to hospital and receiving brief alcohol intervention
|
Brief alcohol intervention already implemented in daily routine by the individual hospitals.
|
|
Age 61-70
Patients aged 61-70 when admitted to hospital and receiving brief alcohol intervention
|
Brief alcohol intervention already implemented in daily routine by the individual hospitals.
|
|
Age 71-80
Patients aged 71-80 when admitted to hospital and receiving brief alcohol intervention
|
Brief alcohol intervention already implemented in daily routine by the individual hospitals.
|
|
Age 81 and older
Patients aged 81 and older when admitted to hospital and receiving brief alcohol intervention
|
Brief alcohol intervention already implemented in daily routine by the individual hospitals.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alcohol use disorder (AUD)
Time Frame: Three years
|
Diagnosis of AUD after recruitment in the study
|
Three years
|
|
Prescriptions for AUD
Time Frame: Three years
|
Prescriptions for the treatment of alcohol use disorder
|
Three years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health care
Time Frame: Three years
|
Diagnoses and procedures in primary and secondary health care
|
Three years
|
|
Trauma
Time Frame: Three years
|
Serious trauma registered in trauma registry
|
Three years
|
|
Death
Time Frame: Three years
|
Death and cause of death
|
Three years
|
|
Prescriptions for addictive drugs
Time Frame: Three years
|
Prescriptions for any drug with addictive potential
|
Three years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ID734
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alcohol Dependence
-
BrainswayRecruitingAlcohol Dependence | Alcoholism | Alcohol Use Disorder | Alcohol Abuse | Alcohol Addiction | Alcohol Abuse/DependenceUnited States, Israel
-
University Hospital, LilleCompleted
-
Tel-Aviv Sourasky Medical CenterMinistry of Health, IsraelUnknownAlcohol-dependenceIsrael
-
Pop Test Oncology LLCBaylor College of Medicine; Michael E. DeBakey VA Medical Center; Congressionally... and other collaboratorsCompletedPotential Treatment for Alcohol Dependence-Alcohol InteractionUnited States
-
National Institute on Alcohol Abuse and Alcoholism...CompletedAlcohol Abuse | Alcohol Dependence (Primary Condition)United States
-
University Hospital, Gentofte, CopenhagenCompleted
-
Massachusetts General HospitalCompletedAlcohol Dependence | Drug Abuse | Alcohol Abuse | Drug DependenceUnited States
-
University of WashingtonU.S. Army Medical Research and Development CommandCompletedAlcohol Dependence | Substance Abuse | Alcohol Abuse | Substance DependenceUnited States
-
Anders Fink-Jensen, MD, DMSciThe Novavì outpatient clinics, Copenhagen; Neurobiology Research Unit, Rigshospitalet... and other collaboratorsCompletedAddiction, Alcohol | Alcohol Dependence, in RemissionDenmark
-
Psychiatric Centre RigshospitaletThe Novavì outpatient clinics, CopenhagenRecruitingAddiction, Alcohol | Alcohol Dependence, in RemissionDenmark
Clinical Trials on Brief alcohol intervention
-
Centre for Addiction and Mental HealthNot yet recruiting
-
University of Texas at AustinNational Institute on Alcohol Abuse and Alcoholism (NIAAA)CompletedDrinking Behavior | Injury RecidivismUnited States
-
The University of Hong KongRecruitingMetabolic Dysfunction-Associated Steatotic Liver Disease | Metabolic Alcohol-Related Liver DiseaseHong Kong
-
University of VirginiaNational Cancer Institute (NCI); United States Air ForceCompleted
-
Massachusetts General HospitalNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Not yet recruitingAlcohol Use DisorderUnited States
-
SangathCompletedHazardous DrinkingIndia
-
The University of Tennessee, KnoxvilleNational Institute on Alcohol Abuse and Alcoholism (NIAAA); Butler HospitalUnknownAlcohol Use | Intimate Partner ViolenceUnited States
-
Centre for Addiction and Mental HealthCanadian Cancer Society (CCS)Completed
-
Peking UniversityActive, not recruitingAlcohol Use DisorderChina
-
Brown UniversityCompletedHIV | Hazardous DrinkingUnited States