NCT02188043

Brief Summary

The purpose of this study is to evaluate the Relay Model helping alcohol dependent patients at a general hospital to start specialized alcohol treatment in order to assess i) efficacy, ii) cost-effectiveness and iii) overall societal cost impacts. The effect of the Relay Model will be investigated in a single-blind pragmatic randomised controlled trial in which the control group consists of patients referred to treatment by usual procedures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

September 29, 2017

Status Verified

September 1, 2017

Enrollment Period

3.6 years

First QC Date

July 9, 2014

Last Update Submit

September 28, 2017

Conditions

Keywords

Alcohol use disorderMotivational InterventionHealth expendituresefficacy study

Outcome Measures

Primary Outcomes (1)

  • health care expenditures

    Primary measure is Health care expenditures 12 months after discharge, according to the International Classification of Health Accounts, extracted from population registers.

    12 - 60 months

Secondary Outcomes (1)

  • report to alcohol clinic

    30 days

Study Arms (2)

Relay Model

OTHER

AUDIT score 8+: Brief Motivational Intervention with alcohol therapist. AUDITscore16+:Brief Motivational Intervention and appointment at Alcohol Treatment Clinic \-

Behavioral: Relay Model

Usual Referral Procedure

NO INTERVENTION

Hospital staff refer patient to Alcohol Treatment Clinic according to usual procedure

Interventions

Relay ModelBEHAVIORAL

The Clinical staff hand out and collect lifestyle - questionnaires to admitted patients, and screen by 10 alcohol questions (AUDIT) , and report score to outpatient Alcohol Clinic. Based on the questionnaire that the patient filled out, the Alcohol therapist perform a brief Motivational Intervention on patients with an AUDIT score of 8+, focusing the patients alcohol consumption habits and offer an appointment to patients with an AUDIT score of 16+.

Relay Model

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalized for a minimum of 24 hours
  • Resident within the uptake area of the involved alcohol treatment centres
  • Willing to participate in the study
  • Cognitive and physical capable

You may not qualify if:

  • In any alcohol-specific treatment for alcohol dependence
  • Psychotic
  • Less than 18 years of age
  • Hospitalized less than 24 hours
  • Resident outside uptake areas
  • Not consenting on participation in the study
  • Cognitive and physical incapable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RESCueH alcohol Studies, Unit of Clinical Alcohol Research, Psyciatric Research Unit, Clinical Institute, University of Southern Denmark

Odense, DK - 5000 C, Denmark

Location

Related Publications (1)

  • Schwarz AS, Bilberg R, Bjerregaard L, Nielsen B, Sogaard J, Nielsen AS. Relay model for recruiting alcohol dependent patients in general hospitals--a single-blind pragmatic randomized trial. BMC Health Serv Res. 2016 Apr 14;16:132. doi: 10.1186/s12913-016-1376-8.

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Bent Nielsen, Ph.D

    bent.nielsen@rsyd.dk

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 9, 2014

First Posted

July 11, 2014

Study Start

November 1, 2013

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

September 29, 2017

Record last verified: 2017-09

Locations