Alcohol Use DisorderRelayNCT02188043
Project Relay Model for Recruiting Alcohol Dependent Patients in General Hospitals
A study testing Relay Model in people with Alcohol Use Disorder and Alcohol Dependency, run by University of Southern Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder, Alcohol Dependency
- What is being tested?
- Relay Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2013to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
RESCueH alcohol Studies, Unit of Clinical Alcohol Research, Psyciatric Research Unit, Clinical Institute, University of Southern Denmark
Odense, DK - 5000 C
About this study
Official title: Relay Model for Recruiting Alcohol Dependent Patients in General Hospitals - A Single-blind Pragmatic Randomised Trial
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.
Read the 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.
- Conditions
- Alcohol Use Disorder, Alcohol Dependency
- Being tested
- Relay Model
- Keywords
- Alcohol use disorder, Motivational Intervention, Health expenditures, efficacy study
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relay ModelBehavioural
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 group | Role | What they receive |
|---|---|---|
| Relay Model | Other | AUDIT score 8+: Brief Motivational Intervention with alcohol therapist. AUDITscore16+:Brief Motivational Intervention and appointment at Alcohol Treatment Clinic
- Receives: Behavioral: Relay Model |
| Usual Referral Procedure | No intervention | Hospital staff refer patient to Alcohol Treatment Clinic according to usual procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 - 60 months
Secondary outcomes (1)
report to alcohol clinic
Secondary outcome is the percentage of the target group, who, 30 days after discharge, reports at the alcohol treatment clinics.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startNov 2013
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kjeld Andersen, University of Southern Denmark
- Investigators
- Bent Nielsen, Ph.D, Principal investigator, bent.nielsen@rsyd.dk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188043
- Sponsor's protocol ID
- RESCueH_Relay
- Acronym
- Relay
- Status last verified
- Sep 2017
- First submitted
- 9 Jul 2014
- Last updated
- 29 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27080865
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relay Model for Recruiting Alcohol Dependent Patients in General Hospitals - A Single-blind Pragmatic Randomised Trial
- ClinicalTrials.gov ID
- NCT02188043
- Acronym / sponsor ID
- Relay / RESCueH_Relay
- Conditions
- Alcohol Use Disorder, Alcohol Dependency
- Keywords
- Alcohol use disorder, Motivational Intervention, Health expenditures, efficacy study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 11 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relay Model | Other | Behavioral: Relay ModelAUDIT score 8+: Brief Motivational Intervention with alcohol therapist. AUDITscore16+:Brief Motivational Intervention and appointment at Alcohol Treatment Clinic - |
| Usual Referral Procedure | No intervention | –Hospital staff refer patient to Alcohol Treatment Clinic according to usual procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- In any alcohol-specific treatment for alcohol dependence
- Psychotic
- Less than 18 years of age
- Hospitalized less than 24 hours
- Resident outside uptake areas
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relay ModelThe 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+. | Behavioural | Relay Model |
Primary outcome
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.
1 secondary outcome
report to alcohol clinic
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2017.
- Derived from this study: PubMed 27080865Schwarz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bent Nielsen, Ph.D principal investigator
bent.nielsen@rsyd.dk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relay Model in people with Alcohol Use Disorder and Alcohol Dependency, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
health care expenditures (time frame: 12 - 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02188043, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2017.