Autonomous Methadone Delivery System by Nurses

Overview

Initiations of methadone treatment for opiode use disorder (OUD) are carried out in France in specialized centers, known as centers for care, support and prevention in addictology (CSAPA) In this way, hospital practitioners initiate the prescription of methadone, which is delivered on the spot by the nursing team. CSAPA nurses, and addictology nurses more generally, have a real range of skills which can include adapting treatment doses according to a protocol pre-established in a team, and medically validated (French law no. 2019-774 of July 24, 2019 relating to the organization and transformation of the healthcare system). The methadone speciality used for initiation in CSAPAs is almost always the syrup form. The capsule form can only be used after one year's treatment, unless exceptionally authorized by the medical officer of the French National Health Insurance Fund. However, regulations stipulate that the prescription of methadone syrup must be renewed every fourteen days, which in theory means that a CSAPA doctor must see the patient at least twice a month to renew the prescription, throughout the entire course of treatment. In practice, medical resources are often not sufficient for patients to be seen by a doctor at such a rate. Numerous palliative organizations exist, though they remain poorly described and documented. In some centers, doctors focus primarily on initiations, and prescriptions for patients for whom "stability" has been achieved are sometimes renewed for longer periods than fourteen days, with nurses in charge of assessing whether this organization is suitable for the patient. The notion of stability varies significantly from one center to another, and may mean achieving a constant dose, stopping illicit opioid use, or other criteria more focused on the patient's psychosocial reintegration. By outlining the missions of Addictology nurses, and more specifically of CSAPA nurses, the investigators can define the essential skills required of nurses to carry out these missions. The main hypothesis of the DIADEME study is that semi-autonomous management of methadone treatment initiation by CSAPA nursing teams helps to reinforce adherence to care and thus improve retention rates in the 3 months following initiation.

Interventions

• Procedure DIADEME strategy
  This strategy consists of implementing the standardized DIADEME protocol. It, in line with best practice recommendations, enables nurses to adjust methadone dosage on the basis of a clinical assessment scheme incorporating opioid withdrawal and overdosing and includes: * initial medical consultation with the hospital practitioner for an addictology and psychiatry assessment, OUD assessment, and initial prescription of methadone for 3 months * ECG prior to any methadone prescription, hepatitis B
• Procedure Controle strategy
  The control strategy corresponds to standard practice guidelines for patients suffering from drug addiction, with the care pathway provided by the hospital practitioner, assisted by the nursing team.
• Procedure Individual semi directive interview
  Individual semi-directive interviews with a sample of patients from the DIADEME group (2 to 3 volunteer patients per CSAPA for a total of 20 to 30 interviews) will be conducted by a research psychologist and carried out at one month after the end of follow-up (3 months). Themes covered will include: commitment to care, patient/professional relationship, understanding of follow-up and treatment, experience of care and services at the addictology center, satisfaction with services received, level

Primary outcome measures

• Patient retention in care [Time frame: 3 months]

Secondary outcome measures (12)

• Euroqol EQ-5D 5 (EuroQol-5 Dimensions, 5 Levels Questionnaire) score [Time frame: 3 months]
• Medical cost of each strategy (DIADEME and Controle strategy) [Time frame: 3 months]
• Opioid withdrawal [Time frame: At 2 and 3 months]
• CSQ-8 (Client Satisfaction Questionnaire) score [Time frame: 3 months]
• Total methadone doses [Time frame: over the 3-month follow-up period]
• Overdose episode [Time frame: At 1, 2 and 3 months]
• Hospital admissions [Time frame: At 1, 2 and 3 months]
• Adverse event [Time frame: At 1, 2 and 3 months]
• Opiate withdrawal [Time frame: At 1, 2 and 3 months]
• Montgomery and Asberg Depression Rating Scale (MADRS) score [Time frame: Between inclusion and 3 months]
• State-Trait Anxiety Inventory (STAI) score [Time frame: Between inclusion and 3 months]
• Cannabis Use Disorder Identification Test - Revised (CUDIT-R) score [Time frame: Between inclusion and at 1, 2 and 3 months]

Eligibility criteria

Inclusion criteria

• Subject 18 years of age or older,
• With opioid use disorder (OUD) according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria (other authorized psychoactive substance use),
• Intending to start methadone treatment for OUD in a CSAPA center within 7 days,
• Agreeing to be followed up in a CSAPA over the next 3 months,

Exclusion criteria

• Having taken methadone treatment (on prescription) in the three months prior to inclusion,
• Simultaneous medical care in another addictology facility,
• with a day-hospital project,
• Referral to town prescriber or town pharmacy planned and/or requested by patient before 3 month,
• Non-stabilized psychiatric disorder or cognitive impairment likely to compromise compliance and involvement in care (at investigator's discretion),
• Inability to communicate and express themselves in French language,
• Subject to a legal protection measure other than curatorship,
• Pregnant or breast-feeding.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

France · 8 centers

• CSAPA, Association Bizia, Centre Hospitalier de la Côte Basque — Bayonne
• CSAPA, Service d'Addictologie, Centre Hospitalier Charles Perrens, CHU de Bordeaux — Bordeaux
• CSAPA de Brioude — Brioude
• CSAPA, Association Nationale de Prévention en Alcoologie et Addictologie (ANPAA), Résidenc — Le Puy-en-Velay
• CSAPA, Service Universitaire d'Addictologie de Lyon, Hôpital Edouard Herriot, Hospices Civ — Lyon
• CSAPA, Hôpital de la Croix Rousse, Hospices Civils de Lyon — Lyon
• CSAPA, Service de Psychiatrie et d'Addictologie, Hôpital Civil, CHRU de Strasbourg — Strasbourg
• CSAPA du Griffon, Oppelia Aria 69 — Villeurbanne

Identifiers

NCT: NCT07085377 · 69HCL23_0905

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗