AlcoTail - Implementation of Tailored Interventions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOslo University Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients admitted to Medical wards
Disqualifiers
Inability to understand written and verbal Norwegian
Cognitive or mental inability to consent to participation
Injury or planned surgery as primary reason for admission
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Harmful alcohol use treatment
BehavioralPatients 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.
Non-prescribed psychoactive medicinal use treatment
BehavioralPatients 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.
Treatment groups
4,200 Participants
are divided into 2 treatment groupsGroup A: Control group0 interventions
Group B: Case group2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
2 months2
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).
Time frame
12 monthsSecondary outcomes
1
Changes in patient's health outcomes
Assess changes in patient's health outcomes defined as changes in diagnostic parameters in health registries, measured by changes in registered ICD-10 codes.
Time frame
12 months2
Changes in patient's use of health care services
Assess changes in use of secondary health care services, measured by number of hospital admissions,
Time frame
12 months3
Changes in patient's referals to specialist health care
Assess changes in referrals to specialist health care, measured by number of referals.
Time frame
12 months4
Changes in patient's use of primary healthcare
Assess changes in use of primary health care measured by number of PCP visits.
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Oslo University Hospital
Lead sponsor
St. Olavs Hospital
Collaborator
Lovisenberg Diakonale Hospital
Collaborator
Oslo Municipality
Collaborator
Source ClinicalTrials.gov