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Assessment of the Satisfaction of Patient Undergoing Opioid Replacement Therapy Toward Their Management in Community Pharmacy (SATISFY)

30. december 2021 opdateret af: University Hospital, Clermont-Ferrand

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.

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

Patients will be recruited in addiction departments, associations for risk management and general practitioners, and a paper questionnaire will be sent to the patients. The questionnaire is anonymous.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

98

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Clermont-Ferrand, Frankrig, 63000
        • CHU de Clermont-Ferrand

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patient undergoing opioid replacement therapy

Beskrivelse

Inclusion Criteria:

  • Patient undergoing opioid replacement therapy

Exclusion Criteria:

  • Age <18 years
  • Patient unable to understand or write in French

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
cohorte 1
patients undergoing opioid replacement therapy
patients undergoing opioid replacement therapy
Andre navne:
  • no intervention or other

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. januar 2018

Primær færdiggørelse (Faktiske)

21. maj 2019

Studieafslutning (Faktiske)

21. maj 2019

Datoer for studieregistrering

Først indsendt

22. maj 2019

Først indsendt, der opfyldte QC-kriterier

22. maj 2019

Først opslået (Faktiske)

23. maj 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. januar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. december 2021

Sidst verificeret

1. december 2021

Mere information

Begreber relateret til denne undersøgelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Opioid-relaterede lidelser

Kliniske forsøg med patients undergoing opioid replacement therapy

Abonner