- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상세 설명
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Clermont-Ferrand, 프랑스, 63000
- CHU de Clermont-Ferrand
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patient undergoing opioid replacement therapy
Exclusion Criteria:
- Age <18 years
- Patient unable to understand or write in French
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
cohorte 1
patients undergoing opioid replacement therapy
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patients undergoing opioid replacement therapy
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Score of satisfaction
기간: day 1
|
visual analogic scale (VAS) "Are you satisfied with your management by community pharmacists?"
0: not satisfied - 100: totally satisfied
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day 1
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Prevention tips given by the pharmacist: risk of infection, overdose, way of using drugs, adverse effects and drug interactions
기간: day 1
|
yes/no
|
day 1
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Services rendered by the pharmacist: sale of sterile equipment, management of soiled waste, dispensing of opioid replacement therapy
기간: day 1
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yes/no
|
day 1
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Perception of the profile / behaviour of pharmacists: welcoming and open to discussion
기간: day 1
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VAS, 0: not at all - 100 : totally
|
day 1
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Perception of the profile / behaviour of pharmacists: respect for confidentiality
기간: day 1
|
VAS, 0: not at all - 100 : totally
|
day 1
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Perception of the profile / behaviour of pharmacists: competent
기간: day 1
|
VAS, 0: not at all - 100 : totally
|
day 1
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opioid replacement therapy
기간: day 1
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name, dose, route
|
day 1
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Number of physician consulted for the last 6 months
기간: day 1
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number
|
day 1
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Number of community pharmacy consulted for the last 6 months
기간: day 1
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number
|
day 1
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duration of opioid use disorder
기간: day 1
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number of years/months
|
day 1
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Demographic information
기간: day 1
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: age, sex, study level, marital status, health care insurance, monthly income, type of housing
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day 1
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CHU-434
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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