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NCT Number: NCT06381609

Peer Support in Alcohol Dependence

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.

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Behavior Behavior, Addictive Chemically-Induced Disorders Compulsive Behavior Impulsive Behavior Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Le Vinatier, Bron, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quality life questionnaire AQoLS

Behavioral

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

Behavioral

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

Peer support consultations

Other

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

Primary outcomes

  1. Unplanned cessation of care at 6 months

    Time frame: At 6 months after inclusion

    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

Secondary outcomes

  1. Number of unfulfilled consultations

    Time frame: 6 months after inclusion

    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.

  2. Euroqol-5D-5L questionnaire score

    Time frame: At inclusion, 3 and 6 months after inclusion

    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).

  3. Difference in costs (in euros)

    Time frame: At 1, 2 and 3 years after the beginning of implementation on French territory

    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.

  4. Number of AUD criteria according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5)

    Time frame: At inclusion, 3 and 6 months after inclusion

  5. Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) score

    Time frame: At inclusion, 3 and 6 months after inclusion

  6. average number of standard drinks declared per week

    Time frame: At inclusion, 3 and 6 months after inclusion

  7. Alcohol Quality of Life Scale (AQoLS) score

    Time frame: At inclusion, 3 and 6 months after inclusion

    Changes in quality of life will be measured using the AQoLS

  8. State-Trait Anxiety Inventory (STAI-Y) score

    Time frame: At inclusion, 3 and 6 months after inclusion

    Changes in levels of anxiety will be measured using STAI-Y

  9. Montgomery-Åsberg Depression Rating Scale (MADRS) score

    Time frame: At inclusion, 3 and 6 months after inclusion

    Changes in levels of depression will be measured using MADRS

  10. Cannabis Use Disorders Identification Test - Revised (CUDIT-R) score

    Time frame: At inclusion, 3 and 6 months after inclusion

    Changes in the severity of cannabis use will be measured by the CUDIT-R score

  11. type of opioid use

    Time frame: At inclusion, 3 and 6 months after inclusion

  12. frequency of opioid use

    Time frame: At inclusion, 3 and 6 months after inclusion

  13. type of psychostimulant use

    Time frame: At inclusion, 3 and 6 months after inclusion

  14. frequency of psychostimulant use

    Time frame: At inclusion, 3 and 6 months after inclusion

  15. Fagerström test score

    Time frame: At inclusion, 3 and 6 months after inclusion

    Tobacco use will be measured by the Fagerström test

  16. Health Care Satisfaction Questionnaire (HCSQ) score

    Time frame: At 6 months after inclusion

    Patient's satisfaction will be measured by HCSQ questionnaire

  17. Number of hospitalisations

    Time frame: At 6 months after inclusion

    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)

  18. Service organization description

    Time frame: Before setting up of the study

  19. Description of type of support and missions performed by Peer Support

    Time frame: After last visit of last patient (around 3,5 years after first inclusion)

  20. Acceptability of Intervention Measure (AIM) score

    Time frame: After last visit of last patient (around 3,5 years after first inclusion)

    AIM score measured in Peer Support and medical staff

  21. AIM score

    Time frame: At 6 months after inclusion

    AIM score measured in patients

  22. Adoption of intervention

    Time frame: After last visit of last patient (around 3,5 years after first inclusion)

    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

  23. Intervention fidelity

    Time frame: After last visit of last patient (around 3,5 years after first inclusion)

    intervention fidelity will be assessed by monitoring APSS activity indicators, describing deviations from the protocol and semi-structured interviews

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin ROLLAND, Professor

CONTACT

[email protected]

04 37 91 50 75 ext. +33

Nathalie Perreton

CONTACT

[email protected]

04 27 85 63 04 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: PEERSIAD

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Apr 24, 2024
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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