The Connect Trial: Connecting Hospital Patients to Alcohol Care

NCT07482150 | Not Yet Recruiting

• 1 other identifier: SJ-1130
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Alcohol Use Disorder

Keywords

alcohol misuse treatment; inhospital alcohol care; pilot study; implementation study

Outcome Measures

Primary Outcomes (3)

• Recruitment

  \>50% of eligible individuals invited to the study give written informed consent

  6 months

• Retention

  \>50% individuals recruited and randomized to the intervention, will attend to the intervention of seing the AUD therapist at least once

  6 months

• Completion

  \>50% of all randomized study participants complete the follow-up interview and blood sample

  6 months

Secondary Outcomes (12)

• AUD treatment engagement after 6 and 12 months

  12 months

• Mortality after 6 and 12 months

  12 months

• 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

• Change in blood phosphatidyl ethanol level from baseline to 6 months after inclusion

  6 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

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.

Other: Guidance and leaflet on AUD treatment facilities outside the hospital

Intervention group

EXPERIMENTAL

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 last for 20 to 60 minutes and can take place either at the department where the patient is admitted or elsewhere to ensure confidentiality. Up to 10 sessions 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 alcohol treatment facility. The participant will also be informed about other options for specialised alcohol treatment, group therapy, peer support and self-help groups.

Other: AUD treatment sessions with an outreach alcohol therapist at the hospital

Interventions

AUD treatment sessions with an outreach alcohol therapist at the hospital OTHER

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.

Intervention group

Guidance and leaflet on AUD treatment facilities outside the hospital OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Zealand University Hospital, Department of Medicine

Køge, 4600, Denmark

Location

Related Publications (2)

• Schwarz AS, Nielsen B, Sogaard J, Sogaard Nielsen A. Making a bridge between general hospital and specialised community-based treatment for alcohol use disorder-A pragmatic randomised controlled trial. Drug Alcohol Depend. 2019 Mar 1;196:51-56. doi: 10.1016/j.drugalcdep.2018.12.017. Epub 2019 Jan 17.

  PMID: 30665152 BACKGROUND

• Incze MA, Kelley AT, James H, Nolan S, Stofko A, Fordham C, Gordon AJ. Post-hospitalization Care Transition Strategies for Patients with Substance Use Disorders: A Narrative Review and Taxonomy. J Gen Intern Med. 2024 Apr;39(5):837-846. doi: 10.1007/s11606-024-08670-5. Epub 2024 Feb 27.

  PMID: 38413539 BACKGROUND

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol; Counseling

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Gro Askgaard

  Sjaellands Universitetshospital Køge, Medicinsk Afdeling

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gro Askgaard, MD, PhD

CONTACT

60142280; gras@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: allocation concealment
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 19, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2031
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)