- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Clermont-Ferrand, Frankrig, 63000
- CHU de Clermont-Ferrand
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patient undergoing opioid replacement therapy
Exclusion Criteria:
- Age <18 years
- Patient unable to understand or write in French
Studieplan
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:
|
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
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Kemisk inducerede lidelser
- Stof-relaterede lidelser
- Narkotika-relaterede lidelser
- Opioid-relaterede lidelser
- Lægemidlers fysiologiske virkninger
- Depressive midler til centralnervesystemet
- Agenter fra det perifere nervesystem
- Analgetika
- Sensoriske systemagenter
- Narkotika
- Analgetika, Opioid
Andre undersøgelses-id-numre
- CHU-434
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Opioid-relaterede lidelser
-
University Hospital, Clermont-FerrandAfsluttetOral Health Related Quality of Life (OHRQoL)Frankrig
-
Riyadh Elm UniversityAfsluttetOral Health Related Quality of Life OHRQoLSaudi Arabien
-
University of MalayaUkendtTranspalatal bue (TPA) | Oral Health Related Quality of Life (OHRQoL) | Oral Health Impact Profile Short Version 14 (OHIP 14) | Ortodontiske smerter | Tredimensionel (3D) ortodontisk enhedMalaysia
-
University of North Carolina, Chapel HillIkke rekrutterer endnuOpioid ordinationForenede Stater
-
Montefiore Medical CenterRekrutteringOpioid tilspidsendeForenede Stater
-
University of MichiganThe Benter FoundationAfsluttetOpioid ordinationForenede Stater
-
matthieu clanetAfsluttet
-
University of MichiganNational Institute on Drug Abuse (NIDA)AfsluttetOpioid ordinationForenede Stater
-
University of North Carolina, Chapel HillNorth Carolina Department of Health and Human ServicesAfsluttetAnalgetika OpioidForenede Stater
-
Purdue Pharma LPAfsluttetOpioid analgesiForenede Stater, Australien, Finland, New Zealand
Kliniske forsøg med patients undergoing opioid replacement therapy
-
Dialco Medical Inc.Trukket tilbage
-
University of ParmaUkendtAkut nyresvigt | Hypofosfatæmi | Dialyserelateret komplikation | HypomagnesæmiItalien
-
Malihe MahmoudiniaIkke rekrutterer endnuIVF resultater
-
Stanford UniversityAfsluttetKronisk smerte | Opioidbrug
-
Clinical Research Centre, MalaysiaUkendtPost-operativ smerteMalaysia
-
Jessa HospitalRekrutteringAnalgesi | Kirurgi | Postoperative smerter | HjertesygdomBelgien
-
The Royal Bournemouth HospitalRoyal Bournemouth and Christchurch Hospitals NHS Foundation TrustAfsluttetSmertekontrol | Artroplastik, udskiftning af knæDet Forenede Kongerige
-
Charite University, Berlin, GermanyAfsluttetSmerte | Prostatektomi | Transversus Abdominis flyblokadeTyskland
-
Uppsala UniversityThe Kamprad Family Foundation for Entrepreneurship, Research & CharityRekrutteringOpioidbrugsforstyrrelse | Alkoholbrugsforstyrrelse | Opioidbrug | Smerte, kroniskSverige
-
Taipei Veterans General Hospital, TaiwanIkke rekrutterer endnuAnæstesi | Lægemiddelinteraktion | Anæstesi; FunktionelTaiwan