Clinical trial NCT04927455: Pilot Study to Evaluate "Intégrer et Accompagner Les Consommations d'Alcool!" (IACA!)'s Impact and Transferability
Official title: Pilot Study to Evaluate Impact and Transferability of an Alcohol Focused Harm Reduction Support System Based on Mental Health Recovery Named IACA!
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Craving
Addiction, Alcohol
Alcoholism
Keywords: Public Health; Alcohol use and addiction; risk reduction; innovation; mental health recovering; Transferability; Viability; Pilot study
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This research will investigate three types of populations:

* Individuals receiving support from the IACA! Intervention (called beneficiaries),
* Professionals implementing the IACA! Intervention i.e. the pairs in charge of accompanying the beneficiaries in the centers as well as the persons in charge of these centers,
* Professionals from Santé! supporting the deployment of the IACA! intervention.

The beneficiaries are all persons integrating the program in the project's partner sites and consuming alcohol.

The professionals will be specialized educators, social workers, nurses, social and solidarity economy advisors, etc.

Brief summary: In France, alcohol consumption is the second most common cause of so-called preventable cancers after tobacco. Since 2014, in the "Provence-Alpes-Côte d'Azur" (PACA) region, the association Santé! has been developing an innovative intervention to support people suffering from alcohol-related addiction. This intervention, called IACA! must therefore be evaluated on a larger scale before conclusions about its effectiveness can be drawn from a comparative trial.

This evaluation requires significant human and material resources. It is therefore recommended to first assess the transferability of IACA! in other care centers in a pilot study.

Detailed description: In France, 11% of cancers in men and 4.5% of cancers in women are attributed to alcohol consumption. It is the second leading cause of so-called preventable cancers, accounting for 28,000 alcohol-related cancers out of 352,000 new cases of cancer affecting annually adults (over 30 years of age). Overall, alcohol is among the top 3 factors contributing to Disability-Adjusted life year (DALYs) in France in 2017. Some cancer risks can be quantified as early as one drink a day (oesophagus, oral cavity, pharynx and breast in women). However, the risks associated with alcohol consumption remain influenced by the quantities consumed. There is therefore an interest, particularly for consumers of the largest quantities, in reducing the quantities consumed. In Europe, while people who drink more than 60 g/d of alcohol for men and 40 g/d for women are estimated to represent only 16.1% of the population for men and 9.3% for women, they represent 87% and 82% of alcohol-related morbidity and mortality respectively. Subjects with addiction (or substance use disorders) have an increased risk of social harm (1.5 to 3 times that of alcohol users without addiction), a higher mortality (1.4 to 6.5 compared to the general population) with a life expectancy of 9 to 20 years shorter than that of the general population. Moreover, even if the quantities consumed are not a valid individual diagnostic criterion, studies show a strong association between the quantity consumed and the diagnosis of addiction. Finally, some studies suggest that the prevalence of secondary harm from alcohol use follows an exponential curve as a function of alcohol consumption.

Since 2014, in the PACA region, the association Santé! has been developing an intervention to support people suffering from alcohol-related addiction. This intervention, called IACA! (Integrating and supporting alcohol consumption), differs from the support provided during rehabilitation cures and aims to: fight against discrimination and exclusion of people who drink alcohol, re-engage these individuals in the care process (because they have generally left it) by using the appropriate levers, promote well-being, improve quality of life and recovery and support the recovery in control of consumption. Thus, IACA!, through its philosophy and implementation, is based both on the risk reduction approach historically deployed with drug users and on the recovery approach, developed in the field of mental health. The first one-year results of this program were promising since, of 17 people who received the intervention, all had a social or health benefit, 13 of whom were associated with stabilization (n=4), reduction (n=7) or cessation (n=2) of alcohol use.

These promising results must therefore be evaluated on a larger scale before conclusions about its effectiveness can be drawn from a comparative trial. This type of evaluation requires significant human and material resources. It is therefore recommended to first assess in the field: 1) the conditions under which such an intervention is deployed in other centres (adaptations implemented by other centres to deploy IACA! for example, without distorting the intervention), 2) the acceptability and feasibility of the intervention in other centres (are the human and material resources on site sufficient for the successful deployment of the intervention?), 3) the acceptability and feasibility of the large-scale evaluation envisaged.

Eligibility criteria: Inclusion criteria common to the 3 populations:

* Over 18 years of age
* whatever the gender
* Non-opposition to participate

Inclusion criteria for professionals from centers implementing IACA! :

Concerning professionals in contact with the patients:

* Having been trained at IACA!
* Working in the centers participating in the implementation of IACA!

Concerning the persons in charge of the centers :

These professionals are those who have participated in the deployment of the IACA! method in their centers

Criteria for the inclusion of health professionals ! Participating or having recently participated in the implementation of IACA!

Exclusion Criteria:

The beneficiaries will be excluded if they have a severe somatic or psychiatric pathology that is incompatible with understanding the assessment tools; difficulty understanding and/or writing French; if they are unreachable by telephone, if they are participating in another research project with an ongoing exclusion period, if they are placed under court protection and if they are pregnant.

Primary outcomes:
measure: Severity of alcohol use
timeFrame: 12 months after the start of IACA
Secondary outcomes:
measure: Utility dimension of viability - alcohol consumption
timeFrame: Baseline (M0)
measure: Utility dimension of viability - alcohol consumption
timeFrame: 3 months (M3)
measure: Utility dimension of viability - alcohol consumption
timeFrame: 6 months (M6)
measure: Utility dimension of viability - alcohol consumption
timeFrame: 9 months (M9)
measure: Utility dimension of viability - alcohol consumption
timeFrame: 12 months (M12)
measure: Utility dimension of viability - craving
timeFrame: Baseline (M0)
measure: Utility dimension of viability - craving
timeFrame: 3 months (M3)
measure: Utility dimension of viability - craving
timeFrame: 6 months (M6)
measure: Utility dimension of viability - craving
timeFrame: 9 months (M9)
measure: Utility dimension of viability - craving
timeFrame: 12 months (M12)
measure: Utility dimension of viability - severity
timeFrame: Baseline (M0)
measure: Utility dimension of viability - severity
timeFrame: 3 months (M3)
measure: Utility dimension of viability - severity
timeFrame: 6 months (M6)
measure: Utility dimension of viability - severity
timeFrame: 9 months (M9)
measure: Utility dimension of viability - severity
timeFrame: 12 months (M12)
measure: Utility dimension of viability - disorders
timeFrame: Baseline (M0)
measure: Utility dimension of viability - disorders
timeFrame: 3 months (M3)
measure: Utility dimension of viability - disorders
timeFrame: 6 months (M6)
measure: Utility dimension of viability - disorders
timeFrame: 9 months (M9)
measure: Utility dimension of viability - disorders
timeFrame: 12 months (M12)
measure: Utility dimension of viability - Other substances
timeFrame: Baseline (M0)
measure: Utility dimension of viability - Other substances
timeFrame: 3 months (M3)
measure: Utility dimension of viability - Other substances
timeFrame: 6 months (M6)
measure: Utility dimension of viability - Other substances
timeFrame: 9 months (M9)
measure: Utility dimension of viability - Other substances
timeFrame: 12 months (M12)
measure: Utility dimension of viability - Inventory
timeFrame: Baseline (M0)
measure: Utility dimension of viability - Inventory
timeFrame: 3 months (M3)
measure: Utility dimension of viability - Inventory
timeFrame: 6 months (M6)
measure: Utility dimension of viability - Inventory
timeFrame: 9 months (M9)
measure: Utility dimension of viability - Inventory
timeFrame: 12 months (M12)
measure: Utility dimension of viability - QoL
timeFrame: Baseline (M0)
measure: Utility dimension of viability - QoL
timeFrame: 3 months (M3)
measure: Utility dimension of viability - QoL
timeFrame: 6 months (M6)
measure: Utility dimension of viability - QoL
timeFrame: 9 months (M9)
measure: Utility dimension of viability - QoL
timeFrame: 12 months (M12)
measure: Conditions of transferability
timeFrame: 9 to 12 months (M9 to M12)
measure: Viability and implementation
timeFrame: 6 to 12 months (M6 to M12)
measure: Viability and utility
timeFrame: 6 to 12 months (M6 to M12)
measure: Viability and affordability
timeFrame: 6 to 12 months (M6 to M12)
measure: Viability and evaluability
timeFrame: 6 to 12 months (M6 to M12)
measure: Viability and adaptability
timeFrame: 6 to 12 months (M6 to M12)
measure: Viability and acceptability
timeFrame: 6 to 12 months (M6 to M12)
measure: Feasibility study capacity
timeFrame: 12 months (M12)
measure: Feasibility study complicance
timeFrame: 12 months (M12)
measure: Feasibility study ressources
timeFrame: 12 months (M12)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CH Perrens - Equipe Addiction
city: Bordeaux
country: France
facility: MéRISP - Université U1219
Study officials:
affiliation: Bordeaux University Hospital, Bordeaux University U1219
name: Linda Cambon, PhD
role: STUDY_CHAIR
affiliation: Bordeaux University Hospital, Bordeaux University U1219
name: François Alla, MD, PhD
role: STUDY_DIRECTOR
affiliation: CNRS USR 3413 SANPSY, Bordeaux University, Bordeaux Hospital University
name: Marc Auriacombe, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Thabane L, Cambon L, Potvin L, Pommier J, Kivits J, Minary L, Nour K, Blaise P, Charlesworth J, Alla F; Discussion Panel. Population health intervention research: what is the place for pilot studies? Trials. 2019 May 30;20(1):309. doi: 10.1186/s13063-019-3422-4.
citation: Cambon L, Minary L, Ridde V, Alla F. Transferability of interventions in health education: a review. BMC Public Health. 2012 Jul 2;12:497. doi: 10.1186/1471-2458-12-497.
citation: Martin-Fernandez J, Stevens N, Moriceau S, Serre F, Blanc H, Latourte E, Auriacombe M, Cambon L. Realist evaluation of the impact, viability and transferability of an alcohol harm reduction support programme based on mental health recovery: the Vitae study protocol. BMJ Open. 2022 Aug 11;12(8):e065361. doi: 10.1136/bmjopen-2022-065361.