The Connect Trial: Connecting Hospital Patients to Alcohol Care
ConditionAlcohol Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorZealand University Hospital
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Ongoing specialized treatment for AUD
Not speaking Danish
Not living in the catchment area of Zealand University hospital
Age < 18 years
Trial design
Design model
Parallel
Treatments tested in this trial
AUD treatment sessions with an outreach alcohol therapist at the hospital
Other interventionParticipants 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.
Guidance and leaflet on AUD treatment facilities outside the hospital
Other interventionParticipants 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
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Control groupActive comparator 1 intervention
Group B: Intervention groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment
\>50% of eligible individuals invited to the study give written informed consent
Time frame
6 months2
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 months3
Completion
\>50% of all randomized study participants complete the follow-up interview and blood sample
Time frame
6 monthsSecondary outcomes
1
AUD treatment engagement after 6 and 12 months
No predefined goal
Time frame
12 months2
Mortality after 6 and 12 months
No predefined goal
Time frame
12 months3
Change in drinks (containing 12 g ethanol) per last 30 days from baseline till 6 months after inclusion
Time frame
6 months4
Proportion with abstinence or light drinking (<10 drinks/week) last 30 days
yes or no
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov