Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04957628 |
| Other study ID # |
31052 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 13, 2021 |
| Est. completion date |
December 2025 |
Study information
| Verified date |
September 2022 |
| Source |
Oslo University Hospital |
| Contact |
Anners Lerdal, PhD |
| Phone |
23 22 50 00 |
| Email |
anners.lerdal[@]medisin.uio.no |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
Patients included in the study before the implementation of the intervention protocols will
be assigned to the control group. These patients will receive acute medical care according to
current procedures. Patients included in the study after implementation of intervention
protocols will be assigned to the case group. In addition to acute medical care, these
patients will be routinely screened for harmful alcohol consumption using Alcohol Use
Disorder Identification Test (AUDIT-C). Patients scoring < 4 points (men) / 3 points (women)
will not receive any intervention. Patients scoring 4-6 points (men) / 3-5 points (women)
will be informed about the possible harmful effects of their consumption and will be advised
to reduce their consumption. From patients scoring > 6 points (men) >5 points (women) a blood
sample will be collected and analyzed for relevant biomarkers. They will be further evaluated
using Prediction of Alcohol Withdrawal Severity Scale (PAWSS). Patients at risk of developing
delirium tremens will be treated according to Clinical Institute Withdrawal Assessment
(CIWA-Ar) procedures, and referred to specialized alcohol addiction treatment. Patients in
the case group that has prescription(s) for psychoactive medicinal drugs will also be
routinely evaluated by pharmacological assessment of drug concentration in serum samples. If
there is a discrepancy between prescribed dose and serum concentration, or medicinal drugs
other than those being prescribed are found, the patient will be advised to use medicines
according to prescription or have their prescribed dosage altered. If necessary, the patient
will be referred to specialized drug addiction treatment.
The patients will be recruited from 3 hospitals: Oslo University Hospital, Lovisenberg
Diakonale Hospital (Oslo) and St Olav Hospital (Trondheim). The recruitment period will be
approximately 4 months for the control group and 4 months for the case group, and estimations
based on previous admission numbers for the 3 hospitals results in about 2500 patients in
each group.
For the study, research personnel will approach the eligible patients once they have been
admitted to various medical wards. The personnel will give the patients written and verbal
information about the study, and the patients who agree to be part of the study will sign a
written consent. Baseline data will be recorded for all patients included in the control and
case groups. These data include:
- Alcohol use past 12 months, Alcohol Use Disorder Identification Test (AUDIT-4)
- Alcohol use last 24 hours,
- Stages-of-change questionnaire on alcohol, psychoactive medicinal and/or illicit drug
use past 12 months,
- Non-prescribed use of psychoactive medicinal drugs past 12 months
- Drug Use Disorder Identification Test (DUDIT)
- Stages-of-change questionnaire on psychoactive medicinal drugs or illicit drugs
- Symptoms Checklist (SCL-5)
- Left-over blood samples used for routine diagnostic testing will be collected and
analyzed for ethanol, phosphatidylethanol (PEth; biomarker for alcohol use last 3
weeks), diazepam, N-desmethyldiazepam, clonazepam, oxazepam, nitrazepam, alprazolam,
zopiclone, zolpidem, morphine, codeine, oxycodone, buprenorphine, methadone, tramadol,
amphetamine, methamphetamine, ecstasy (MDMA), THC, cocaine and benzoylecgonine.
- Patients in the case group will be invited to submit a new blood sample for PEth
analysis 2 months after inclusion.
- After 12 months, baseline data will be coupled to the following data from the patient
journal: date and time of admission, days and hours spent at bed-post and intensive
care, number of previous hospital admissions, ICD-10 diagnoses at discharge, level of
care, AUDIT-C score, ethanol and PEth concentration in blood, psychoactive medicine
concentration in serum, CIWA-Ar, Glasgow Coma Scale (GCS) score, first triage at
hospital, medicinal curve at admission, marital status, employment status, care status
for children under 18 years of age. Data will also be coupled to various registry data;
The Norwegian Patient Registry: number of admissions in the specialist health care
service 5 years prior to admission, number of treatments with main diagnosis from ICD-10
the within 5 years prior to admission, number of admissions to interdisciplinary
specialist treatment within 5 years after admission, number of admissions within 5 years
after admission; The Social Security Database: performance status at time of admission
and 1 year after; The Norway Control and Payment of Health Reimbursement (KUHR) Database
and the Norwegian Registry for Primary Health Care: patients use of institutions and
other primary health care services such as home nursing and nursing homes 5 years prior
to and 5 years after admission, overview of drug use diagnoses; the Norwegian
Prescription Registry: medication prescribed 5 years prior to and 5 years after
admission; and the Cause of Death Registry: cause of death within 5 years after
admission.
The database from baseline (questionnaires and blood sample analysis), patient journal data
and the various registry data collected from each included patient will be treated
de-identified. The questionnaires will be in an online-format ("Nettskjema"), and the data
will be submitted directly in a secure database provided by the University of Oslo, called
Services for Sensitive Data (short form "TSD" in Norwegian).
In the final database, missing values in variables will result in exclusion of that patient
in statistical analysis (when the variable with missing value is part of a specific
analysis). Statistical analyses will include:
For the alcohol intervention:
- To control for baseline measures, multiple models for repeated measures will be used to
evaluate anticipated differences between the intervention and the control groups. For
the continuous outcomes (number of admissions and GP visits) linear mixed models will be
fitted, for binary outcomes models with log link or Poisson link function will be used.
For the psychoactive medicinal drug intervention:
- Multiple mixed effects models for repeated measures will be fitted. The three different
institutions will be entered as random effects, while selected covariates as patients'
age and gender will be modeled as fixed effects. Continuous outcomes (serum
concentrations) will be analyzed using linear mixed models, while changes in
prescriptions with the outcome being binary will be modeled using mixed models with log
or Poission link function. The results will be expressed as effect sizes (for linear
models) or relative risks (RR) for models of binary outcomes.
