Alcohol ConsumptionNCT04164940
Patient Trajectories for Older Adults Admitted to Hospital for Alcohol-related Problems
An observational study of Alcohol Consumption and Alcohol; Harmful Use, run by Helse Stavanger HF at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alcohol Consumption, Alcohol; Harmful Use, Health Risk Behaviors
- What is being tested?
- Brief alcohol intervention
- How many people
- 500 participants
- Where
- 1 siteNorway
- Study dates
- 23 Oct 2019to Dec 2030
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 21 years or older admitted to medical or surgical hospital wards offering some kind of screening and brief alcohol intervention as part of the daily routine, and without a prior diagnosis of AUD or SUD.
Who may be able to join
- 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
Who cannot join
- specialized treatment for alcohol use disorder og drug use disorder during the three years prior to recruitment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
StavangerUH
Stavanger, 4068
Torgeir G Lid, MD PhD, +4748187477, torgeir.gilje.lid@sus.no
About this study
Official title: 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.
Read the 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).
- Being tested
- Brief alcohol intervention
- Medical subject headings
- Alcohol Drinking, Health Risk Behaviors, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief alcohol interventionOther
Brief alcohol intervention already implemented in daily routine by the individual hospitals.
| Study group | Role | What they receive |
|---|---|---|
| Age 21-30 | Patients aged 21-30 when admitted to hospital and receiving brief alcohol intervention Receives: Other: Brief alcohol intervention | |
| Age 31-40 | Patients aged 31-40 when admitted to hospital and receiving brief alcohol intervention Receives: Other: Brief alcohol intervention | |
| Age 41-50 | Patients aged 41-50 when admitted to hospital and receiving brief alcohol intervention Receives: Other: Brief alcohol intervention | |
| Age 51-60 | Patients aged 51-60 when admitted to hospital and receiving brief alcohol intervention Receives: Other: Brief alcohol intervention | |
| Age 61-70 | Patients aged 61-70 when admitted to hospital and receiving brief alcohol intervention Receives: Other: Brief alcohol intervention | |
| Age 71-80 | Patients aged 71-80 when admitted to hospital and receiving brief alcohol intervention Receives: Other: Brief alcohol intervention | |
| Age 81 and older | Patients aged 81 and older when admitted to hospital and receiving brief alcohol intervention Receives: Other: Brief alcohol intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol use disorder (AUD)
Diagnosis of AUD after recruitment in the study
Measured: Three years
Prescriptions for AUD
Prescriptions for the treatment of alcohol use disorder
Measured: Three years
Secondary outcomes (4)
Health care
Diagnoses and procedures in primary and secondary health care
Measured: Three years
Trauma
Serious trauma registered in trauma registry
Measured: Three years
Death
Death and cause of death
Measured: Three years
Prescriptions for addictive drugs
Prescriptions for any drug with addictive potential
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start23 Oct 2019
- Primary completionDec 2023 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- Helse Vest, Helse Fonna, Helse Møre og Romsdal HF, Sorlandet Hospital HF, Helse Sor-Ost, Lovisenberg Diakonale Hospital, Oslo University Hospital, Vestre Viken Hospital Trust
- Responsible party
- Sponsor
- Investigators
- Torgeir G Lid, MD PhD, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164940
- Sponsor's protocol ID
- ID734
- Status last verified
- Nov 2023
- First submitted
- 12 Nov 2019
- Last updated
- 24 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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+)
- ClinicalTrials.gov ID
- NCT04164940
- Acronym / sponsor ID
- ID734
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- Helse Vest, Helse Fonna, Helse Møre og Romsdal HF, Sorlandet Hospital HF, Helse Sor-Ost, Lovisenberg Diakonale Hospital, Oslo University Hospital, Vestre Viken Hospital Trust
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Age 21-30 | – | Other: Brief alcohol interventionPatients aged 21-30 when admitted to hospital and receiving brief alcohol intervention |
| Age 31-40 | – | Other: Brief alcohol interventionPatients aged 31-40 when admitted to hospital and receiving brief alcohol intervention |
| Age 41-50 | – | Other: Brief alcohol interventionPatients aged 41-50 when admitted to hospital and receiving brief alcohol intervention |
| Age 51-60 | – | Other: Brief alcohol interventionPatients aged 51-60 when admitted to hospital and receiving brief alcohol intervention |
| Age 61-70 | – | Other: Brief alcohol interventionPatients aged 61-70 when admitted to hospital and receiving brief alcohol intervention |
| Age 71-80 | – | Other: Brief alcohol interventionPatients aged 71-80 when admitted to hospital and receiving brief alcohol intervention |
| Age 81 and older | – | Other: Brief alcohol interventionPatients aged 81 and older when admitted to hospital and receiving brief alcohol intervention |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 21 years or older admitted to medical or surgical hospital wards offering some kind of screening and brief alcohol intervention as part of the daily routine, and without a prior diagnosis of AUD or SUD.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- specialized treatment for alcohol use disorder og drug use disorder during the three years prior to recruitment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief alcohol interventionBrief alcohol intervention already implemented in daily routine by the individual hospitals. | Other | Age 21-30, Age 31-40, Age 41-50, Age 51-60, Age 61-70, Age 71-80, Age 81 and older |
Primary outcome
Alcohol use disorder (AUD)
Time frame: Three years
Diagnosis of AUD after recruitment in the study
Prescriptions for AUD
Time frame: Three years
Prescriptions for the treatment of alcohol use disorder
4 secondary outcomes
Health care
Time frame: Three years
Trauma
Time frame: Three years
Death
Time frame: Three years
Prescriptions for addictive drugs
Time frame: Three years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Torgeir G Lid, MD PhD principal investigator
Helse Stavanger HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Consumption and Alcohol; Harmful Use, run by Helse Stavanger HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Torgeir G Lid, MD PhD (+47 48187477, torgeir.gilje.lid@sus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol use disorder (AUD) (time frame: Three years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.