AlcoTail - Implementation of Tailored Interventions

NCT04957628 | Recruiting

• 1 other identifier: 31052
• Study Type: observational
• Target: 4,200
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the implementation and real-world effects of an intervention for harmful use of alcohol and psychoactive medicinal drugs among hospital inpatients. Due to the negative impact of alcohol consumption on health outcomes, a call for action has been made by the Norwegian Ministry of Health, with focus on screening patients for alcohol consumption and evidence-based tailored interventions for those with medium or high consumption. In addition, non-prescribed use of psychoactive medicinal drugs, or concomitant use with alcohol, can also have negative health effects, therefore improved monitoring of the use of these are warranted. Interventions will be introduced as routine procedures at Norwegian hospitals in the upcoming year, and 2500 patients receiving acute medical care will be included in the control group before the intervention is implemented, and 2500 patients in the case group after the implementation is effectuated. This study will evaluate the implementation process using baseline data on self-reported alcohol- and psychoactive medicine use, motivation to reduce consumption and mental distress. In addition, left-over blood samples used for diagnostic purposes will be collected and analyzed for alcohol, psychoactive medicinal and illicit drugs. After 12 months baseline data will be coupled to patient journal data and relevant registry data in order to evaluate the effects of the intervention.

Conditions

Alcohol Consumption; Psychoactive Substance Use

Keywords

Alcohol; Psychoactive drugs; Intervention; Somatic patients

Outcome Measures

Primary Outcomes (2)

• Changes in alcohol consumption

  Assess changes in alcohol consumption for patients identified with medium or high alcohol consumption will be assessed using the blood biomarker phosphatidyletanol (PEth), measured in nM. PEth will be measured at baseline and after 2 months, if feasible.

  2 months

• Changes in use of psychoactive medicinal drugs

  Assess changes in use of psychoactive substances, if the patient is adviced to reduce. Measured in changes in prescription from the prescription database. Measuerd in defined daily dose (DDD).

  12 months

Secondary Outcomes (4)

• Changes in patient's health outcomes

  12 months

• Changes in patient's use of health care services

  12 months

• Changes in patient's referals to specialist health care

  12 months

• Changes in patient's use of primary healthcare

  12 months

Study Arms (2)

Control group

2500 participants will be recruited before the intervention procedures are implemented at the respective hospitals. Baseline data on alcohol, psychoactive medicinal and illicit drug use (AUDIT-4 and DUDIT), stages-of-change questionnaire on alcohol, medicinal drugs and illicit drug use, and mental distress will be recorded. Left-over full blood from routine diagnostic testing will be collected and analyzed for alcohol biomarkers (ethanol and phosphatidylethanol (PEth)) and psychoactive medicinal and illicit drugs. The participants in the control group will receive acute medical treatment according to hospital procedures. After 12 months, the data from baseline will be coupled to data from patient journals and data from relevant registries.

Case group

2500 participants will be recruited after the intervention procedures are implemented. Baseline data on alcohol, psychoactive medicinal and illicit drug use, stages-of-change questionnaires, and mental distress will be recorded. Left-over blood from diagnostic testing will be collected and analyzed for alcohol biomarkers (ethanol and phosphatidylethanol (PEth)) and psychoactive medicinal and illicit drugs. The participants in the case group will receive treatment according to new hospital procedures, including screening for harmful alcohol use and non-prescribed use of psychoactive medicinal drugs and intervention. If feasible, a new blood sample will be collected 2 months after inclusion, which will be analyzed for PEth. After 12 months, the data from baseline will be coupled to patient journals and relevant registries.

Behavioral: Harmful alcohol use treatment; Behavioral: Non-prescribed psychoactive medicinal use treatment

Interventions

Harmful alcohol use treatment BEHAVIORAL

Patients identified through routine hospital screening as having a potentially harmful alcohol use (AUDIT-C 4-6 points (men) / 3-5 points (women) will receive information about the possible harmful effects of their drinking and will be advised to reduce their consumption. Patients identified with more excessive drinking patterns (AUDIT-C \> 6 (men) / \> 5 (women) will be assessed with blood sample analysis of relevant alcohol biomarkers, psychological assessments for alcohol addiction and withdrawal symptoms, and if necessary referral to alcohol addiction treatment. Patients with severe withdrawal symptoms will be put in CIWA-Ar observation.

Case group

Non-prescribed psychoactive medicinal use treatment BEHAVIORAL

Patients with prescription on psychoactive medicinal drugs are pharmacologically assessed using serum sample analysis. Patients identified with discrepancy in prescribed doses and serum concentrations will have doses adjusted, or be referred to addiction treatment. Patients identified with psychoactive medicinal drugs other than those prescribed will be advised to quit those medications, or be referred to addiction treatment.

Case group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients admitted to medical wards at Oslo University Hospital, Lovisenberg Diakonale Hospital and St Olav Hospital during recruitment periods that are eligible for the study.

You may qualify if:

• Patients admitted to Medical wards

You may not qualify if:

• Inability to understand written and verbal Norwegian
• Cognitive or mental inability to consent to participation
• Injury or planned surgery as primary reason for admission

Sponsors & Collaborators

• Oslo University Hospital: lead
• St. Olavs Hospital: collaborator
• Lovisenberg Diakonale Hospital: collaborator
• Oslo Municipality: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Left-over material (EDTA full blood) from routine diagnostic purposes will be collected from all study participants once they are enrolled in the study.

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Central Study Contacts

Anners Lerdal, PhD

CONTACT

23 22 50 00; anners.lerdal@medisin.uio.no

Stig Tore Bogstrand, PhD

CONTACT

23013041; stig.tore.bogstrand@ous-hf.no

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 12, 2021
• Study Start: September 13, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)