- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03961789
Assessment of the Satisfaction of Patient Undergoing Opioid Replacement Therapy Toward Their Management in Community Pharmacy (SATISFY)
Assessment of the Satisfaction of Patient Undergoing Opioid Replacement Therapy Toward Their Management in Community Pharmacy - SATISFY: a Cross-sectional Study
The patient's compliance to his medication therapy, and therefore the success of the treatment, is particularly related to his pharmacy management. Thus, the satisfaction of an individual in their interview with the pharmacist is a very important element.
The pharmacist in his professional activity may have to manage patients with opioid related disorders. Pharmacist activity will result in the dispensing of opioid replacement therapy (ORT), single-use syringes, harm reduction kits and prevention advices for the reduction of toxicity and infection risks.
Since the 1990s, the consumption of ORT has been steadily increasing. According to the OFDT (French Observatory of Drugs and Drug Addiction), the number of patients undergoing ORT is about 150 000 patients. Since high-dose buprenorphine is prescribed for approximately two-thirds of patients, it remains the most frequently prescribed ORT in France.
Recently, a French association assisting drug users (ASUD - Auto-support des usagers de drogues) performed a study in Paris (20/07/2018 - 25/08/2018) to assess the delivery of opioid replacement therapies by community pharmacists. In this study, 71% of pharmacists refused to deliver opioid replacement therapies. The main reasons reported were security (56%) and activity saturation, meaning that pharmacists considered that they had too many patients using opioid drugs. In France, the refusal of a pharmacist to deliver drugs is a punishable offence. According to the Code of ethics of pharmacists, pharmacists must respect life and people without discrimination. Pharmacists have a low perception of patients suffering from opioid addiction. Another study performed by ASUD in 93 community pharmacies, showed that pharmacists used the term "toxicomaniacs" instead of "drug users". Most pharmacists had had a bad experience with drugs users, with physical and verbal aggressions. The conclusions of this study showed that pharmacists lacked knowledge of drug users and drug use. Pharmacists knew about harm reduction kits for opioid users (containing sterile syringes, needles, water, antiseptics, etc.) and had already opened them, but very few knew how to use them. More worryingly, some pharmacists did not understand the harm reduction strategies available It thus appears that community pharmacists have a difficult relationship with patient suffering of opioid related disorders, which can have an impact on patient's satisfaction.
The objective of this study will be to assess the satisfaction of patients undergoing ORT regarding their management by community pharmacists.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
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Clermont-Ferrand, Francia, 63000
- CHU de Clermont-Ferrand
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Patient undergoing opioid replacement therapy
Exclusion Criteria:
- Age <18 years
- Patient unable to understand or write in French
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
cohorte 1
patients undergoing opioid replacement therapy
|
patients undergoing opioid replacement therapy
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Score of satisfaction
Lasso di tempo: day 1
|
visual analogic scale (VAS) "Are you satisfied with your management by community pharmacists?"
0: not satisfied - 100: totally satisfied
|
day 1
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Prevention tips given by the pharmacist: risk of infection, overdose, way of using drugs, adverse effects and drug interactions
Lasso di tempo: day 1
|
yes/no
|
day 1
|
|
Services rendered by the pharmacist: sale of sterile equipment, management of soiled waste, dispensing of opioid replacement therapy
Lasso di tempo: day 1
|
yes/no
|
day 1
|
|
Perception of the profile / behaviour of pharmacists: welcoming and open to discussion
Lasso di tempo: day 1
|
VAS, 0: not at all - 100 : totally
|
day 1
|
|
Perception of the profile / behaviour of pharmacists: respect for confidentiality
Lasso di tempo: day 1
|
VAS, 0: not at all - 100 : totally
|
day 1
|
|
Perception of the profile / behaviour of pharmacists: competent
Lasso di tempo: day 1
|
VAS, 0: not at all - 100 : totally
|
day 1
|
|
opioid replacement therapy
Lasso di tempo: day 1
|
name, dose, route
|
day 1
|
|
Number of physician consulted for the last 6 months
Lasso di tempo: day 1
|
number
|
day 1
|
|
Number of community pharmacy consulted for the last 6 months
Lasso di tempo: day 1
|
number
|
day 1
|
|
duration of opioid use disorder
Lasso di tempo: day 1
|
number of years/months
|
day 1
|
|
Demographic information
Lasso di tempo: day 1
|
: age, sex, study level, marital status, health care insurance, monthly income, type of housing
|
day 1
|
Collaboratori e investigatori
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Disordini mentali
- Disturbi indotti chimicamente
- Disturbi Correlati a Sostanze
- Disturbi correlati agli stupefacenti
- Disturbi correlati agli oppioidi
- Effetti fisiologici delle droghe
- Depressori del sistema nervoso centrale
- Agenti del sistema nervoso periferico
- Analgesici
- Agenti del sistema sensoriale
- Narcotici
- Analgesici, oppioidi
Altri numeri di identificazione dello studio
- CHU-434
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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