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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
60
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.
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
Zealand University Hospital, Department of Medicine
Køge, Denmark
Recruitment
\>50% of eligible individuals invited to the study give written informed consent
Time frame: 6 months
Retention
\>50% individuals recruited and randomized to the intervention, will attend to the intervention of seing the AUD therapist at least once
Time frame: 6 months
Completion
\>50% of all randomized study participants complete the follow-up interview and blood sample
Time frame: 6 months
AUD treatment engagement after 6 and 12 months
No predefined goal
Time frame: 12 months
Mortality after 6 and 12 months
No predefined goal
Time frame: 12 months
Change in drinks (containing 12 g ethanol) per last 30 days from baseline till 6 months after inclusion
Time frame: 6 months
Proportion with abstinence or light drinking (<10 drinks/week) last 30 days
yes or no
Time frame: 6 months
Change in blood phosphatidyl ethanol level from baseline to 6 months after inclusion
Time frame: 6 months
Change in motivation to cut down on alcohol (yes or no), calculated as the difference between baseline and 6 months follow-up
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Time frame: 6 months
Number of AUD treatment sessions
Time frame: 6 months
Proportion initiating medical AUD therapy
Time frame: 6 months
Proportion receiving medical AUD treatment at 6- and 12 months follow up
Time frame: 12 months
Number of acute hospital admissions or emergency room visits at 6 and 12 months
Time frame: 12 months
Number of hospital outpatient visits at 6 and 12 months
Time frame: 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
Time frame: 3 years