- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Clermont-Ferrand, Frankrike, 63000
- CHU de Clermont-Ferrand
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Patient undergoing opioid replacement therapy
Exclusion Criteria:
- Age <18 years
- Patient unable to understand or write in French
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
cohorte 1
patients undergoing opioid replacement therapy
|
patients undergoing opioid replacement therapy
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Score of satisfaction
Tidsramme: day 1
|
visual analogic scale (VAS) "Are you satisfied with your management by community pharmacists?"
0: not satisfied - 100: totally satisfied
|
day 1
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Prevention tips given by the pharmacist: risk of infection, overdose, way of using drugs, adverse effects and drug interactions
Tidsramme: day 1
|
yes/no
|
day 1
|
|
Services rendered by the pharmacist: sale of sterile equipment, management of soiled waste, dispensing of opioid replacement therapy
Tidsramme: day 1
|
yes/no
|
day 1
|
|
Perception of the profile / behaviour of pharmacists: welcoming and open to discussion
Tidsramme: day 1
|
VAS, 0: not at all - 100 : totally
|
day 1
|
|
Perception of the profile / behaviour of pharmacists: respect for confidentiality
Tidsramme: day 1
|
VAS, 0: not at all - 100 : totally
|
day 1
|
|
Perception of the profile / behaviour of pharmacists: competent
Tidsramme: day 1
|
VAS, 0: not at all - 100 : totally
|
day 1
|
|
opioid replacement therapy
Tidsramme: day 1
|
name, dose, route
|
day 1
|
|
Number of physician consulted for the last 6 months
Tidsramme: day 1
|
number
|
day 1
|
|
Number of community pharmacy consulted for the last 6 months
Tidsramme: day 1
|
number
|
day 1
|
|
duration of opioid use disorder
Tidsramme: day 1
|
number of years/months
|
day 1
|
|
Demographic information
Tidsramme: day 1
|
: age, sex, study level, marital status, health care insurance, monthly income, type of housing
|
day 1
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CHU-434
Legemiddel- og utstyrsinformasjon, studiedokumenter
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