此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

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

2021年12月30日 更新者: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.

研究概览

详细说明

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.

研究类型

观察性的

注册 (实际的)

98

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Clermont-Ferrand、法国、63000
        • CHU de Clermont-Ferrand

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patient undergoing opioid replacement therapy

描述

Inclusion Criteria:

  • Patient undergoing opioid replacement therapy

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
cohorte 1
patients undergoing opioid replacement therapy
patients undergoing opioid replacement therapy
其他名称:
  • no intervention or other

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Score of satisfaction
大体时间:day 1
visual analogic scale (VAS) "Are you satisfied with your management by community pharmacists?" 0: not satisfied - 100: totally satisfied
day 1

次要结果测量

结果测量
措施说明
大体时间
Prevention tips given by the pharmacist: risk of infection, overdose, way of using drugs, adverse effects and drug interactions
大体时间:day 1
yes/no
day 1
Services rendered by the pharmacist: sale of sterile equipment, management of soiled waste, dispensing of opioid replacement therapy
大体时间:day 1
yes/no
day 1
Perception of the profile / behaviour of pharmacists: welcoming and open to discussion
大体时间:day 1
VAS, 0: not at all - 100 : totally
day 1
Perception of the profile / behaviour of pharmacists: respect for confidentiality
大体时间:day 1
VAS, 0: not at all - 100 : totally
day 1
Perception of the profile / behaviour of pharmacists: competent
大体时间:day 1
VAS, 0: not at all - 100 : totally
day 1
opioid replacement therapy
大体时间:day 1
name, dose, route
day 1
Number of physician consulted for the last 6 months
大体时间:day 1
number
day 1
Number of community pharmacy consulted for the last 6 months
大体时间:day 1
number
day 1
duration of opioid use disorder
大体时间:day 1
number of years/months
day 1
Demographic information
大体时间:day 1
: age, sex, study level, marital status, health care insurance, monthly income, type of housing
day 1

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年1月29日

初级完成 (实际的)

2019年5月21日

研究完成 (实际的)

2019年5月21日

研究注册日期

首次提交

2019年5月22日

首先提交符合 QC 标准的

2019年5月22日

首次发布 (实际的)

2019年5月23日

研究记录更新

最后更新发布 (实际的)

2022年1月14日

上次提交的符合 QC 标准的更新

2021年12月30日

最后验证

2021年12月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅