Autonomous Methadone Delivery System by Nurses (DIADEME)

Civil Hospices of Lyon

Status: Begins enrollment this month

Conditions: Opioid Use Disorder (OUD); Addictology

Treatments: Procedure: Controle strategy; Procedure: Individual semi directive interview; Procedure: DIADEME strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT07085377

69HCL23_0905

Details and patient eligibility

About

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.

Enrollment: 182 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 3 patient groups

Patient DIADEME group

Experimental group

Description:

The patient DIADEME group corresponds to the autonomous nursing system for managing the dispensing of methadone. This standardized protocol, in line with best practice guidelines, enables doses to be adjusted by nurses on the basis of a clinical assessment scheme incorporating the state of opioid withdrawal and overdosing.

Treatment:

Procedure: DIADEME strategy

Procedure: Individual semi directive interview

Patient control group

Other group

Description:

The patient control group is managed in accordance with standard practice guidelines for patients with OUD, with care pathway provided by the hospital practictioner, assisted by nursing team.

Treatment:

Procedure: Controle strategy

Healthcare professionals group

Other group

Description:

Focus groups with healthcare professionals will be held in each CSAPA after the last patient has been included in the center. Each focus group will consist of 6 to 8 professionals, including nurses and doctors involved in implementing the care protocol

Treatment:

Procedure: Individual semi directive interview