An interventional study of Brief Intervention in Alcohol Drinking, sponsored by Hospital Clinic of Barcelona. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-15.
Sponsored by Hospital Clinic of Barcelona · Not applicable, Interventional, and Treatment
Alcohol use and its consequences represent an important public health problem. As well as alcohol dependence, hazardous drinking also contributes to a high burden in terms of morbidity and mortality. To improve these patients' prognosis and decrease associated social and health care costs, it is necessary to increase early detection, intervention and treatment for these problems. For these reasons, SBIRT programmes (Screening Brief Intervention and Referral to Treatment) have been developed, evaluated and shown to be effective, particularly in primary care and general practice. Nevertheless, effectiveness of SBIRT in emergency departments (ED) has not been clearly established.
The investigators aimed to evaluate the feasibility and efficacy of an SBIRT programme in the ED of a tertiary hospital.
The investigators conducted a randomized controlled trial to study the feasibility and efficacy of an SBIRT programme for hazardous drinkers presenting in an ED. All patients older than 18 years old attending the emergency department were potentially eligible. Cognitively impaired or medically unstable patients were excluded. Patients seeking treatment for alcohol use were also excluded. Patients were randomized to two groups, with the control group receiving two leaflets - one regarding alcohol use, and the other giving information about the study protocol. The intervention group received the same leaflets as well as a brief motivational intervention on alcohol use; and, where appropriate, a referral to specialised treatment. The primary outcomes were the proportion of hazardous drinkers measured by AUDIT-C scale and the proportion of patients attending specialised treatment at 1.5 and 4.5 months and 1 year.
701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.
This study's enrollment of 200 is above the median of 122 across 607 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →Hospital Clinic of Barcelona is the lead sponsor of 327 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
Patients received a brief intervention on alcohol use. This brief intervention was a little chat based on motivational techniques to enhance motivation to reduce alcohol use or to initiate treatment. Patients were referred to specialized treatment when indicated.
Behavioral: Brief Intervention
Informative leaflets regarding alcohol use
Patient's received a brief intervention on alcohol use based on motivational techniques, and a referral to treatment when indicated.
Also known as: Referral to treatment
Proportion of Risky Drinkers Measured by AUDIT-C
We assessed participants with AUDIT-C (a tool to assess alcohol consumption). Main outcome 1 is the proportion of patients who score more than 6 i men and 5 in women in this scale. AUDIT-C is the short version of the AUDIT scale (Alcohol use disorders identification test). Consists of a three items scale ( frequency of alcohol consumption, amount of alcohol units per day of consumption and frequency of binge drinking), and ranges from 0 (abstinence) to 12 (very high alcohol use). The higher the score is, the more important the alcohol use is, and more risk of presenting an alcohol use disorder.
Time frame: 6 weeks
Proportion of Patients Attending to Specialized Treatment
Proportion of patients that initate specialized treatment to reduce alcohol use
Time frame: 6 weeks
| Milestone | Intervention | Control |
|---|---|---|
| Started | 99 | 101 |
| Completed | 72 | 81 |
| Not completed | 27 | 20 |
We assessed participants with AUDIT-C (a tool to assess alcohol consumption). Main outcome 1 is the proportion of patients who score more than 6 i men and 5 in women in this scale. AUDIT-C is the short version of the AUDIT scale (Alcohol use disorders identification test). Consists of a three items scale ( frequency of alcohol consumption, amount of alcohol units per day of consumption and frequency of binge drinking), and ranges from 0 (abstinence) to 12 (very high alcohol use). The higher the score is, the more important the alcohol use is, and more risk of presenting an alcohol use disorder.
| Participants | Intervention | Control |
|---|---|---|
| Proportion of Risky Drinkers Measured by AUDIT-C | 20 | 39 |
Proportion of patients that initate specialized treatment to reduce alcohol use
| Participants | Intervention | Control |
|---|---|---|
| Proportion of Patients Attending to Specialized Treatment | 17 | 8 |
Collected over 6 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 2/99 (2%) | 0/99 (0%) | 0/99 (0%) |
| Control | 1/101 (1%) | 0/101 (0%) | 0/101 (0%) |
At baseline, participants' demographic and enrollment-related characteristics were compared across treatment conditions using t- and chi-square tests according to the nature of each variable.
| Age, Continuous(years) | Intervention | Control | Total |
|---|---|---|---|
| Mean | 41.6 ± 16.2 | 44 ± 17.1 | 42.81 ± 16.8 |
| Sex: Female, Male(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Female | 28 | 28 | 56 |
| Male | 71 | 73 | 144 |
| Race and Ethnicity Not Collected(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Alcohol related presenting condition(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Count of participants | 12 | 11 | 23 |
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — There is nno plan, but we have already shared and will continue sharing them
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Since de beginning and for 5 years
Access criteria: For scientific purposes
Ran from Jun 2016 to primary completion in Feb 2018, 20 months.
Results were first posted in May 2020, 2 years 2 months after primary completion.
Of 328 non-industry interventional studies with no phase under Alcohol Drinking, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 20 months is below that.
Counting every sponsor, half of 336 studies reached it within 24 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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