Clinical trial NCT03059628: Evaluation of a Personalized Normative Feedback Repeatedly Delivered Via a Mobile Application After a Brief Therapeutic Intervention on Alcohol-related Risks:
Official title: Evaluation of a Personalized Normative Feedback Repeatedly Delivered Via a Mobile Application After a Brief Therapeutic Intervention on Alcohol-related Risks: a Multi Center Randomized Open Study in Young Adults Admitted to Emergency Room for Acute Alcohol Intoxication (AAI).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Alcohol Intoxication
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: BTI (Brief Therapeutic Intervention) motivates individuals admitted to ED (Emergency Department) for acute intoxication to take actions to prevent further alcohol-related issues. The present project aims at underpinning this intervention by actively involving patients in the monitoring of their alcohol-related risk following discharge. While several web-based preventive interventions towards alcohol already exist, the repeated delivering of PNF (Personalized Normative Feedback) using mobile technology after a BTI constitutes a novel approach to reduce alcohol-related harms. Investigators propose to test the effect of a mobile PNF following a BTI delivered by a psychologist during an ED visit for alcohol intoxication. The mobile PNF will be additionally delivered once a month in the 6-months period after discharge, and once every two months in the following 6-month period, via a smartphone application connected to a central server. The study will include 18-26 years old adults, as this population includes most active students and is often lost to follow-up after ED visits; and aims the reduction of heavy drinking occasions, as this issue account for most of alcohol-related ED visits in this population.

Detailed description: The study will begin simultaneously in all the centers, in September, at the beginning of the university year. When patients will be admitted in the ED for alcohol intoxication, they will first meet the entry nurse, who will make the orientation as usual. Participants will be marked as eligible for the study, and a breath test or a blood alcohol test will be performed. On the following morning, a psychologist will evaluate all potential patients, and check the inclusion criteria. In case of eligibility, the study procedure will be explained and the patient and a medical doctor present in the ED will sign an informed consent. The patient will be included and a baseline assessment will be performed using a web-based questionnaire implemented on a digital tablet. These inputs will automatically generate an identification number and a personal dashboard on a centralized server. Individual codes will be also given to each patient for accessing their personal dashboard on the server from a home computer. The patient will then be randomized, with stratification on center, sex, and absence or presence of a daily consumption of cannabis, between the intervention and the control groups. The psychologist will then perform a brief therapeutic intervention for both groups. Investigators plan to train all psychologists all together to the brief intervention. Then a smartphone application will be installed on the patient's smartphone. Follow-up assessments will be conducted 6 and 12 months after baseline using the same questionnaire, through the smartphone application or on the server website. The application will recall the patient by the means of automatic notifications at 6 and 12 months. Data will be push to the server with the identification number, without any other nominal information. In case patients do not perform the evaluation one week after the expected date, they will be contacted by any means (telephone, postal mail, email or SMS with a link to the software) by a research assistant to recall them to do the evaluation. Participants will be compensated using gift vouchers for the time lost for the interview.

Experimental group :

A personalized normative feedback using a tablet application will be performed after the BTI at ED. The application installed on the patient's smartphone will automatically repeat the PNF, using a local algorithm, once a month over a 6-months period after discharge, and once every two months in the following 6-month period. It will be also possible to perform the PNF on the server website.

Control group :

Patients in the control group will receive the BTI at the ED. The application installed on this group will only realize the evaluation questionnaire.

Eligibility criteria: Inclusion Criteria:

* Aged 18-26 years;
* Admitted for an acute alcohol intoxication to the ED from Thursday to Sunday;
* Need to be kept in the ED for detoxification;
* Alcohol breath test or blood alcohol concentration if breath test impossible greater than 0.5 gram per liter at the admission to the ED;
* Able to understand and remember the component of the study;
* Use of a smartphone;
* Written informed consent.

Exclusion Criteria:

* Patients in police custody and not admitted to emergency;
* Patients admitted for suicidal ideation or attempt;
* Injury requiring an hospitalization;
* Additional need for psychiatric or addiction evaluation;
* Current care in addiction facilities (last contact less than 3 months);
* Planning of a specialized care at the end of the hospitalization;
* Persons participant to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.
* Patients participating in another interventional research

Primary outcomes:
measure: Reduction of the number of heavy drinking occasions
timeFrame: at 12 months
Secondary outcomes:
measure: Reduction of the number of standard drinks
timeFrame: at 6 months and at 12 months
measure: Reduction of the number of heavy drinking occasions
timeFrame: at 6 months
measure: Reduction of the number of alcohol intoxications
timeFrame: at 6 months and at 12 months
measure: Reduction of the number of binge drinking
timeFrame: at 6 months and at 12 months
measure: Reduction of total alcohol consumption
timeFrame: at 6 months and at 12 months
measure: Alcohol related problems
timeFrame: at 6 months and at 12 months
measure: Hospitalisations or admissions in the ED, injuries, violence, unwanted or unprotect sexual behaviours, loss of employment or school problems.
timeFrame: at 6 months and at 12 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: Centre Hospitalier Universitaire Amiens Picardie
city: Angers
country: France
facility: Centre Hospitalier Universitaire Angers
city: Bordeaux
country: France
facility: Hôpital Saint André
city: Rennes
country: France
facility: Centre Hospitalier Universitaire Rennes Pontchaillou
city: Tours
country: France
facility: Centre Hospitalier Régional Universitaire de Tours - Hôpital trousseau
Study officials:
affiliation: Rennes Pontchaillou Hospital
name: Romain MOIRAND, MD/PHD
role: PRINCIPAL_INVESTIGATOR
References: