Alcohol Use Disorder
Conditions
Keywords
alcohol misuse treatment, inhospital alcohol care, pilot study, implementation study
Brief summary
The main objective of this pilot study is to assess feasibility of conducting a definitive RCT with concealed allocation, blinded outcome assessment and a 1:1 parallel group design of A) an invitation to meet an AUD therapist for up to 10 treatment sessions at the hospital in up to 6 months (intervention) compared to B) guidance on how to seek alcohol care in an AUD treatment centre in the community, outside of the hospital (control).
Interventions
OTHERAUD treatment sessions with an outreach alcohol therapist at the hospital
Participants will be offered an AUD treatment session at the hospital the same or next day as they are enrolled in the study with an outreach alcohol therapist from a local AUD treatment facility. The alcohol therapist will be trained in motivational interviewing and cognitive behavioural therapy for AUD. The session will aim to motivate patients to reduce their alcohol consumption and set goals for AUD treatment. The alcohol therapist can recommend a medical therapy to support alcohol reduction or abstinence - this prescription will be undertaken by a hepatologist from the Department of Medicine and may be continued after discharge by patients´ general practitioner or physicians at the AUD treatment facility. Up to 10 sessions of up to 60 minutes of duration at the hospital during 6 months after the baseline visit can be offered and after that, the participant can continue to meet with the same therapist in the community.
OTHERGuidance and leaflet on AUD treatment facilities outside the hospital
Participants randomised as controls will be offered a leaflet informing about different possibilities for alcohol misuse treatments and guidance on how to approach them (may include referral or help with doing an appointment, if possible according to the specific treatment center) in the catchment area of SUH Køge and Roskilde
Sponsors
Zealand University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
allocation concealment
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Hospitalised or seen in an outpatient clinic at SUH Køge * Full-filling international classification of disease version 10: F102: alcohol dependence or F101: harmful alcohol use * Informed written consent * Being able to meet the AUD therapist in connection with a hospital visit with a health condition wholly or partly attributable to alcohol
Exclusion criteria
* Ongoing specialized treatment for AUD * Not speaking Danish * Not living in the catchment area of Zealand University hospital * Age \< 18 years * Enrolled in the Zealand alcohol-related liver disease cohort study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | 6 months | \>50% of eligible individuals invited to the study give written informed consent |
| Retention | 6 months | \>50% individuals recruited and randomized to the intervention, will attend to the intervention of seing the AUD therapist at least once |
| Completion | 6 months | \>50% of all randomized study participants complete the follow-up interview and blood sample |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUD treatment engagement after 6 and 12 months | 12 months | No predefined goal |
| Mortality after 6 and 12 months | 12 months | No predefined goal |
| Change in drinks (containing 12 g ethanol) per last 30 days from baseline till 6 months after inclusion | 6 months | — |
| Proportion with abstinence or light drinking (<10 drinks/week) last 30 days | 6 months | yes or no |
| Change in blood phosphatidyl ethanol level from baseline to 6 months after inclusion | 6 months | — |
| Change in motivation to cut down on alcohol (yes or no), calculated as the difference between baseline and 6 months follow-up | 6 months | — |
| Number of AUD treatment sessions | 6 months | — |
| Proportion initiating medical AUD therapy | 6 months | — |
| Proportion receiving medical AUD treatment at 6- and 12 months follow up | 12 months | — |
| Number of acute hospital admissions or emergency room visits at 6 and 12 months | 12 months | — |
| Number of hospital outpatient visits at 6 and 12 months | 12 months | — |
| 3- year follow-up, conducted through health care registries and AUD treatment facilities to look for incidence of alcohol-related morbidity and mortality, visits to general practitioner and hospital contacts | 3 years | — |
Countries
Denmark
Contacts
CONTACTGro Askgaard, MD, PhD
PRINCIPAL_INVESTIGATORGro Askgaard
Sjaellands Universitetshospital Køge, Medicinsk Afdeling
Outcome results
None listed