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Project Relay Model for Recruiting Alcohol Dependent Patients in General Hospitals (Relay)

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ClinicalTrials.gov Identifier: NCT02188043
Recruitment Status : Completed
First Posted : July 11, 2014
Last Update Posted : September 29, 2017
Sponsor:
Information provided by (Responsible Party):
Kjeld Andersen, University of Southern Denmark

Tracking Information
First Submitted Date  ICMJE July 9, 2014
First Posted Date  ICMJE July 11, 2014
Last Update Posted Date September 29, 2017
Study Start Date  ICMJE November 2013
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2014)
health care expenditures [ Time Frame: 12 - 60 months ]
Primary measure is Health care expenditures 12 months after discharge, according to the International Classification of Health Accounts, extracted from population registers.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2014)
report to alcohol clinic [ Time Frame: 30 days ]
Secondary outcome is the percentage of the target group, who, 30 days after discharge, reports at the alcohol treatment clinics.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Project Relay Model for Recruiting Alcohol Dependent Patients in General Hospitals
Official Title  ICMJE Relay Model for Recruiting Alcohol Dependent Patients in General Hospitals - A Single-blind Pragmatic Randomised Trial
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.

Detailed Description

An increase in individuals with alcohol dependence receiving specialized alcohol treatment will be of major importance for society's response to alcohol problems and its consequences. The Danish population has a large intake of alcohol. Approximately 20% of the adult population are heavy drinkers ( >14/21 drinks/ week (women/men)), 14% are harmful users, and 3% are dependent drinkers. Untreated alcohol use disorders lead to frequent contacts to the health care system associated with considerable human and societal costs. A first approach would be to identify and recruit patients from general hospitals, where the proportion of inpatients with alcohol use disorders range between 16 % and 26%. A referral model to ensure treatment for alcohol dependent patients after discharge is needed.

The main objective of the study is to develop strategies which increase the likelihood that patients report for outpatient alcohol treatment after discharge. It is likely that an optimization of the transfer procedure between hospital and outpatient clinic will lead to that more patients will be engage in psychosocial treatment for their alcohol abuse, which will improve the prognosis, reduce re-admissions and the use of hospital beds and, thus have positive economic consequences. We evaluate the Relay Model in order to assess i) efficacy, ii) cost-effectiveness and iii) overall societal cost impacts.

The target group of the present study is patients suffering from alcohol dependence admitted to a general hospital located in an urban area and a general hospital located in a rural area.

A single-blind pragmatic randomised controlled trial including patients admitted to Hospital. The study group(n=500) receive an Intervention and the control group(n=500) are referred to treatment by usual procedures. All patients complete a lifestyle questionnaire with the Danish self-report version of the Alcohol Use Disorders Identification Test (AUDIT) embedded as a case identification strategy. The patients are informed that an alcohol therapist may contact them and give feedback on their responses.

The completed forms are reviewed daily and an AUDIT score of 8+prompts a call to the Alcohol therapist, who attends the departments on different days randomly drawn by a computer. The RELAY MODEL intervention include a Brief Motivational Intervention. Patients who score AUDIT 16+ are also offered an appointment at the alcohol treatment clinic.

Primary measure is health care expenditures 12 months after discharge, according to the International Classification of Health Accounts, extracted from population registers. The analysis will be repeated on a yearly basis during the following 5 years.

Secondary outcome: The percentage of the target group, who, 30 days after discharge, reports at the alcohol treatment clinics.

A multiple regression model will be used. Since non-treated alcohol disorders generate a high number of societal costs annually for health care, social services, traffic accidents, criminal activities and lost productions we believe the Relay Model to be either cost-neutral or cost-effective, i.e. low net costs compared to effectiveness. We expect to establish evidence that the Relay Model is either cost-neutral or cost-effective, compared to referral by usual procedures.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Alcohol Use Disorder
  • Alcohol Dependency
Intervention  ICMJE Behavioral: Relay Model

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+.

Study Arms  ICMJE
  • Relay Model

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

    -

    Intervention: Behavioral: Relay Model
  • No Intervention: Usual Referral Procedure
    Hospital staff refer patient to Alcohol Treatment Clinic according to usual procedure
Publications * Schwarz AS, Bilberg R, Bjerregaard L, Nielsen B, Søgaard 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2014)
1000
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02188043
Other Study ID Numbers  ICMJE RESCueH_Relay
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kjeld Andersen, University of Southern Denmark
Study Sponsor  ICMJE University of Southern Denmark
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bent Nielsen, Ph.D bent.nielsen@rsyd.dk
PRS Account University of Southern Denmark
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP