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Not yet recruiting NCT07482150

The Connect Trial: Connecting Hospital Patients to Alcohol Care

No phase Interventional Alcohol Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AUD treatment sessions with an outreach alcohol therapist at the hospital, Guidance and leaflet on AUD treatment facilities outside the hospital.
Who it may be relevant to
Registry conditions: Alcohol Use Disorder. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Connect Trial: Connecting Hospital Patients to Alcohol Care - a Randomized Controlled Feasibility Trial

Overview

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

  • Other AUD 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
  • Other Guidance 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

Primary outcome measures

  • Recruitment [Time frame: 6 months]
  • Retention [Time frame: 6 months]
  • Completion [Time frame: 6 months]
Secondary outcome measures (12)
  • AUD treatment engagement after 6 and 12 months [Time frame: 12 months]
  • Mortality after 6 and 12 months [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 [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 [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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Denmark · 1 center
  • Zealand University Hospital, Department of Medicine — Køge

Publications

  • 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
  • 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

Identifiers

NCT: NCT07482150 · SJ-1130

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗