Peer Support in Alcohol Dependence (PEERSIAD)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Behavioral: Quality life questionnaire AQoLS; Behavioral: Quality life questionnaire Euroqol EQ-5D-5L; Other: Peer support consultations

• Study Type: Interventional
• Enrollment (Estimated): 626
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Benjamin ROLLAND, Professor; Phone Number: +33 04 37 91 50 75; Email: Benjamin.ROLLAND@chu-lyon.fr
• Study Contact Backup: Name: Nathalie Perreton; Phone Number: +33 04 27 85 63 04; Email: nathalie.perreton@chu-lyon.fr

Study Locations

• France
  • Bron, France, 69500
    • CH Le Vinatier
    • Contact: Monique GUENIN, MD-PhD; Phone Number: +33 4 37 91 55 55; Email: monique.guenin@ch-le-vinatier.fr
    • Principal Investigator: Monique GUENIN, MD-PhD
  • Clichy, France, 92110
    • Hôpital Beaujon
    • Contact: Delphine MOISAN, MD-PhD; Phone Number: +33 1 40 87 58 82; Email: delphine.moisan@aphp.fr
    • Principal Investigator: Delphine MOISAN, MD-PhD
  • Lyon, France, 69004
    • GH Nord, Hospices Civils de Lyon
    • Contact: Benjamin ROLLAND, Professor
    • Principal Investigator: Benjamin ROLLAND, Professor
    • Sub-Investigator: François BAILLY, MD-PhD
  • Paris, France, 75018
    • Bichat hospital
    • Contact: Pierre-Alexis GEOFFROY, MD-PhD; Phone Number: +33 1 40 25 82 60; Email: pierrealexis.geoffroy@aphp.fr
    • Principal Investigator: Pierre-Alexis GEOFFROY, MD-PhD
  • Paris, France, 75014
    • CHS St Anne
    • Contact: Clément VANSTEENE, MD-PhD
    • Contact: Clément
    • Principal Investigator: VANSTEENE, MD-PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peer support Group; 313 patients will be recruited over 3 years in the peer support group. Patients will be accompanied by an addiction peer support specialist, as part of an "add-on" follow-up compared with conventional follow-up (same management as in the control group).	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; Behavioral: 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
Active Comparator: Control Group; 313 patients will be recruited over 3 years in the control group. Patients will receive "as usual" outpatient abstinence-maintenance follow-up, with consultations of all kinds (medical, psychological, nursing, group, etc.)	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; Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Number of AUD criteria according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5)		At inclusion, 3 and 6 months after inclusion
Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) score		At inclusion, 3 and 6 months after inclusion
average number of standard drinks declared per week		At inclusion, 3 and 6 months after inclusion
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
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
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
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
type of opioid use		At inclusion, 3 and 6 months after inclusion
frequency of opioid use		At inclusion, 3 and 6 months after inclusion
type of psychostimulant use		At inclusion, 3 and 6 months after inclusion
frequency of psychostimulant use		At inclusion, 3 and 6 months after inclusion
Fagerström test score	Tobacco use will be measured by the Fagerström test	At inclusion, 3 and 6 months after inclusion
Health Care Satisfaction Questionnaire (HCSQ) score	Patient's satisfaction will be measured by HCSQ questionnaire	At 6 months after inclusion
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
Service organization description		Before setting up of the study
Description of type of support and missions performed by Peer Support		After last visit of last patient (around 3,5 years after first inclusion)
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)
AIM score	AIM score measured in patients	At 6 months after inclusion
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)
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)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Benjamin ROLLAND, Hopsices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 19, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Alcohol; Addiction; Peer support
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: 69HCL22_0901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No