Autonomous Methadone Delivery System by Nurses

The outcome criterion for cost-utility analysis is the number of quality-adjusted life years (QALYs) gained. QALYs will be estimated on the basis of responses to the Euroqol EQ-5D 5L scale.

The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the 5 dimensions.

The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.

The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.

Budgetary impact for funders of extending the system to all CSAPAs in France (if efficiency is demonstrated).

Costs of medical and nursing consultations, care for adverse events, i.e. consultations and hospitalizations, particularly in connection with OST misuse.

Opioid withdrawal is described as the declared absence of opioid use (excluding methadone) with negative urinary toxins (excluding methadone and degradation products)

Patients' overall satisfaction with CSAPA is assesed using the CSQ-8 scale (Client Satisfaction Questionnaire) The CSQ-8 scale consists of 8 questions that assess aspects like quality of service, whether patients' needs were met, likelihood of recommending the program, and overall satisfaction. Patients are asked to rate statements on a 4-point scale and are invited to provide additional comments.

Total methadone doses delivered and related to follow-up time (mg er day) during the follow-up period

Proportion of occurrences of at least one overdose episode (assessed clinically and by monthly patient declaration)

Proportion of all-cause hospital admissions (assessed on the basis of monthly patient declarations, or external data such as medical correspondence)

Proportion of occurrence and number of adverse events and serious adverse events (reported and assessed at each clinical evaluation point)

Proportion of patients with at least one moderate (>25) to severe (>36) opiate withdrawal assessed by the Clinical Opioid Withdrawal Scale (COWS)

Changes in severity of depression is assessed using the Montgomery and Asberg Depression Rating Scale score (MADRS) The Montgomery-Asberg Depression Rating Scale (MADRS) is a widely recognized clinical assessment tool designed to measure the severity of depressive episodes in patients with mood disorders.

The scale consists of ten items, each targeting a different aspect of depression such as apparent sadness, reported sadness, inner tension, sleep disturbances, appetite, concentration, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored on a scale from 0 to 6, with higher scores indicating more severe symptoms. This scoring system allows clinicians to quantify symptoms in a standardized manner, facilitating both the initial assessment of depression severity and the ongoing monitoring of therapeutic interventions.

Changes in anxiety levels is assessed using the State-Trait Anxiety Inventory (STAI) scale.

The State-Trait Anxiety Inventory (STAI) is a 40-item self-report measure of anxiety using a 4-point Likert-type scale (from 0 to 3 points) for each item. It has two scales: State anxiety, i.e. how one feels at the moment; and Trait anxiety, i.e. how one generally feels. Both scales consist of 20 items. The state scale has 10 reverse-scored items, the trait scale has 7.

Changes in cannabis use and use disorder is assesed using the Cannabis Use Disorder Identification Test - Revised (CUDIT-R) score. This questionnaire was designed for self-administration and is scored by adding each of the 8 items. Questions 1-7 are scored on a 0-4 scale. Question 8 is scored 0, 2 or 4.

Assess changes in alcohol dependence using the Alcohol Use Disorders Identification Test (AUDIT-C).

Changes in nicotine consumption is assessed using the Nicotine Dependence Test (FAGERSTROM) scale.

The Fagerstrom Nicotine Dependence Test is designed to provide an ordinal measure of nicotine dependence related to smoking. It contains six items that assess quantity of cigarettes smoked, compulsion to smoke and dependence. It is useful for screening for nicotine dependence and for assessing severity, which can be used for treatment planning and prognostic judgments.The lower is the score, the lower is the level of dependence.

Assess the change in the proportion of psychostimulant use accurrence on patient declaration every month (if yes, type and frequency); Frequency will be measured by the following categories: daily consumption, several times/week, once/week, several times/month, 1 time/month

Quantitative indicators describing compliance with the protocol implemented in CSAPAs (compliance with DIADEME protocol, number of nursing visits, delays, treatment adaptations carried out, requests for medical advice)

Acceptability on the part of patients and professionals at participating centers, perceived effects of monitoring and adaptation of treatment by nursing staff, impact on patient care, professionals' perceptions of the new nursing role, obstacles and levers identified to sustain the intervention.