Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

30. desember 2021 oppdatert av: 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.

Studieoversikt

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

98

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

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:
  • no intervention or other

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

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

29. januar 2018

Primær fullføring (Faktiske)

21. mai 2019

Studiet fullført (Faktiske)

21. mai 2019

Datoer for studieregistrering

Først innsendt

22. mai 2019

Først innsendt som oppfylte QC-kriteriene

22. mai 2019

Først lagt ut (Faktiske)

23. mai 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. januar 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. desember 2021

Sist bekreftet

1. desember 2021

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere