Autonomous Methadone Delivery System by Nurses
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 182
- 试验地点
- 19
- 主要终点
- Patient retention in care
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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,
排除标准
- •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.
研究组 & 干预措施
Patient DIADEME group
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.
干预措施: DIADEME strategy (Procedure)
Patient DIADEME group
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.
干预措施: Individual semi directive interview (Procedure)
Patient control group
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.
干预措施: Controle strategy (Procedure)
Healthcare professionals group
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
干预措施: Individual semi directive interview (Procedure)
结局指标
主要结局
Patient retention in care
时间窗: 3 months
Patient retention in care at 3 months, defined as the last two methadone dispensing appointments honored in the 15 days preceding the end of the study (3 months), in the absence of a documented situation that prevented the patient from honoring his appointments (death, hospitalization, etc.).
Patient retention in care
时间窗: 3 months
Patient retention in care at 3 months, defined as the last two methadone dispensing appointments honored in the 15 days preceding the end of the study (3 months), in the absence of a documented situation that prevented the patient from honoring his appointments (death, hospitalization, etc.).
次要结局
- State-Trait Anxiety Inventory (STAI) score(Between inclusion and 3 months)
- Euroqol EQ-5D 5 (EuroQol-5 Dimensions, 5 Levels Questionnaire) score(3 months)
- Medical cost of each strategy (DIADEME and Controle strategy)(3 months)
- CSQ-8 (Client Satisfaction Questionnaire) score(3 months)
- Total methadone doses(over the 3-month follow-up period)
- Overdose episode(At 1, 2 and 3 months)
- Hospital admissions(At 1, 2 and 3 months)
- Adverse event(At 1, 2 and 3 months)
- Opiate withdrawal(At 1, 2 and 3 months)
- Montgomery and Asberg Depression Rating Scale (MADRS) score(Between inclusion and 3 months)
- Cannabis Use Disorder Identification Test - Revised (CUDIT-R) score(Between inclusion and at 1, 2 and 3 months)
- Alcohol Use Disorders Identification Test (AUDIT-C)(Between inclusion and at 1, 2 and 3 months)
- Fidelity of the DIADEME intervention(Up to 3 months)
- Acceptability of the DIADEME intervention(Up to 3 months)
- CSQ-8 (Client Satisfaction Questionnaire) score(3 months)
- Total methadone doses(over the 3-month follow-up period)
- Euroqol EQ-5D 5 (EuroQol-5 Dimensions, 5 Levels Questionnaire) score(3 months)
- Medical cost of each strategy (DIADEME and Controle strategy)(3 months)
- Opioid withdrawal(At 2 and 3 months)
- Overdose episode(At 1, 2 and 3 months)
- Hospital admissions(At 1, 2 and 3 months)
- Adverse event(At 1, 2 and 3 months)
- Opiate withdrawal(At 1, 2 and 3 months)
- Montgomery and Asberg Depression Rating Scale (MADRS) score(Between inclusion and 3 months)
- State-Trait Anxiety Inventory (STAI) score(Between inclusion and 3 months)
- Cannabis Use Disorder Identification Test - Revised (CUDIT-R) score(Between inclusion and at 1, 2 and 3 months)
- Alcohol Use Disorders Identification Test (AUDIT-C)(Between inclusion and at 1, 2 and 3 months)
- Nicotine Dependence Test (FAGERSTROM) score(Between inclusion and at 1, 2 and 3 months)
- Use of psychostimulant(Between inclusion and at 1, 2 and 3 months)
- Fidelity of the DIADEME intervention(Up to 3 months)
- Acceptability of the DIADEME intervention(Up to 3 months)