Peer Support in Alcohol Dependence

Alcohol Use Disorder Clinical Trial

— PEERSIAD  

Official title:

Contribution of Addiction Peer Support on Adherence to Care and Clinical Outcomes in Alcohol Dependence: a Prospective Controlled Trial With Medico-economic Component

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06381609
• Other study ID #: 69HCL22_0901
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: November 1, 2027

Study information

• Verified date: April 2024
• Source: Hospices Civils de Lyon
• Contact: Benjamin ROLLAND, Professor
• Phone: 04 37 91 50 75
• Email: Benjamin.ROLLAND[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Alcohol use disorder (AUD) affects between 4% and 6% of French adults, and requires appropriate medical treatment. However, 20-40% of patients with AUD are lost to follow-up at an early stage. Consequently, it is important for addiction departments to implement and evaluate innovative tools and interventions, including the involvement of peer support, to help patients remain in care, and to assess whether peer support has a positive impact on their clinical outcome. Addiction peer support specialists (APSSs) are individuals who have personally experienced addiction, and who have decided to use their experience to assist other people going through a similar situation, after completing a specific official graduation. Compared to other caregivers, APSSs may induce in patients a sense of identification which could improve the patient motivation to engage and remain in care. This is the main hypothesis and the main scientific objective of the PEERSIAD study, which will aim to confirm that accompanying patients with AUD using APSSs after alcohol detoxification, reduces the rate of lost-to-follow-up and improves the overall clinical outcome.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 626
• Est. completion date: November 1, 2027
• Est. primary completion date: November 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged = 18
• Socially insured
• Meeting DSM-5 criteria for alcohol use disorder (AUD)
• Abstinent from alcohol and involved in supervised alcohol withdrawal for at least 5 days and no more than 21 days (outpatient or inpatient)
• Starting a post-detoxification outpatient program

Exclusion Criteria:

• Other severe substance use disorder, i.e. DSM-5 criteria = 6 (excluding tobacco)
• Patient under protective measure (safeguard measure, guardianship) or deprived of liberty or in ordered care and hospitalization measures without consent.
• Inability to communicate and express oneself orally in French, compromising the possibility of exchanges between the Peer support and the patient.
• Psychiatric or cognitive comorbidities making inclusion impossible, at the investigator's discretion.
• Individual accompaniment by a Peer support in the 15 days prior to inclusion.

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism

Intervention

Behavioral:
• Quality life questionnaire AQoLS
Quality life questionnaire AQoLS will be completed by patients of both arms at inclusion, three and six months after inclusion
• Quality life questionnaire Euroqol EQ-5D-5L
Quality life questionnaire Euroqol EQ-5D-5L will be completed by patients of both arms at inclusion, three and six months after inclusion

Other:
• Peer support consultations
For patients included in the Peer support group, eight mandatory consultations with a peer support specialist will be performed between the inclusion visit and during the three following months. Patients can request additional consultations with the peer support specialist during the 6 first months of follow-up

Locations

Country	Name	City	State
France	CH Le Vinatier	Bron
France	Hôpital Beaujon	Clichy
France	GH Nord, Hospices Civils de Lyon	Lyon
France	Bichat Hospital	Paris
France	CHS St Anne	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unplanned cessation of care at 6 months	The unplanned cessation of care at 6 months, excluding consultations with an APSS, with no further contact in the following month, is defined as having had a last planned consultation that was not fulfilled between M0 and M6	At 6 months after inclusion
Secondary	Number of unfulfilled consultations	The number of unfulfilled consultations (scheduled consultations, excluding Peer Support consultations, without patient's visit with or without justification) over the 6-month study follow-up period, collected from the medical records of the addictology department.	6 months after inclusion
Secondary	Euroqol-5D-5L questionnaire score	The differential cost-utility ratio, in relation to the innovative strategy including a Peer Support, will be assessed using the Euroqol-5D-5L questionnaire (EQ-5D-5L).	At inclusion, 3 and 6 months after inclusion
Secondary	Difference in costs (in euros)	An additional analysis will be carried out if the cost-utility ratio is positive: Difference in costs (in euros) for the payer (French compulsory health insurance) between a scenario in which the innovative management is implemented and disseminated in practice and on French territory, and a scenario in which usual follow-up is maintained.	At 1, 2 and 3 years after the beginning of implementation on French territory
Secondary	Number of AUD criteria according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5)		At inclusion, 3 and 6 months after inclusion
Secondary	Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) score		At inclusion, 3 and 6 months after inclusion
Secondary	average number of standard drinks declared per week		At inclusion, 3 and 6 months after inclusion
Secondary	Alcohol Quality of Life Scale (AQoLS) score	Changes in quality of life will be measured using the AQoLS	At inclusion, 3 and 6 months after inclusion
Secondary	State-Trait Anxiety Inventory (STAI-Y) score	Changes in levels of anxiety will be measured using STAI-Y	At inclusion, 3 and 6 months after inclusion
Secondary	Montgomery-Åsberg Depression Rating Scale (MADRS) score	Changes in levels of depression will be measured using MADRS	At inclusion, 3 and 6 months after inclusion
Secondary	Cannabis Use Disorders Identification Test - Revised (CUDIT-R) score	Changes in the severity of cannabis use will be measured by the CUDIT-R score	At inclusion, 3 and 6 months after inclusion
Secondary	type of opioid use		At inclusion, 3 and 6 months after inclusion
Secondary	frequency of opioid use		At inclusion, 3 and 6 months after inclusion
Secondary	type of psychostimulant use		At inclusion, 3 and 6 months after inclusion
Secondary	frequency of psychostimulant use		At inclusion, 3 and 6 months after inclusion
Secondary	Fagerström test score	Tobacco use will be measured by the Fagerström test	At inclusion, 3 and 6 months after inclusion
Secondary	Health Care Satisfaction Questionnaire (HCSQ) score	Patient's satisfaction will be measured by HCSQ questionnaire	At 6 months after inclusion
Secondary	Number of hospitalisations	Measurement of the number of hospitalisations related or not to the AUD and the ratio of total hospital days to number of hospital admissions (based on medical records and patient interviews)	At 6 months after inclusion
Secondary	Service organization description		Before setting up of the study
Secondary	Description of type of support and missions performed by Peer Support		After last visit of last patient (around 3,5 years after first inclusion)
Secondary	Acceptability of Intervention Measure (AIM) score	AIM score measured in Peer Support and medical staff	After last visit of last patient (around 3,5 years after first inclusion)
Secondary	AIM score	AIM score measured in patients	At 6 months after inclusion
Secondary	Adoption of intervention	adoption of intervention will be assessed through semi-structured interviews and measurement of the number of patients followed-up versus the number of eligible patients, refusals to be accompanied by APSS, and premature discontinuation of follow-up	After last visit of last patient (around 3,5 years after first inclusion)
Secondary	Intervention fidelity	intervention fidelity will be assessed by monitoring APSS activity indicators, describing deviations from the protocol and semi-structured interviews	After last visit of last patient (around 3,5 years after first inclusion)