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

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ClinicalTrials.gov Identifier: NCT03961789
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
UFR de Pharmacie (Clermont-Ferrand)
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:

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.


Condition or disease Intervention/treatment
Opioid-Related Disorders Other: patients undergoing opioid replacement therapy

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Assessment of the Satisfaction of Patient Undergoing Opioid Replacement Therapy Toward Their Management in Community Pharmacy - SATISFY: a Cross-sectional Study
Actual Study Start Date : January 29, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Group/Cohort Intervention/treatment
cohorte 1
patients undergoing opioid replacement therapy
Other: patients undergoing opioid replacement therapy
patients undergoing opioid replacement therapy
Other Name: no intervention or other




Primary Outcome Measures :
  1. Score of satisfaction [ Time Frame: day 1 ]
    visual analogic scale (VAS) "Are you satisfied with your management by community pharmacists?" 0: not satisfied - 100: totally satisfied


Secondary Outcome Measures :
  1. Prevention tips given by the pharmacist: risk of infection, overdose, way of using drugs, adverse effects and drug interactions [ Time Frame: day 1 ]
    yes/no

  2. Services rendered by the pharmacist: sale of sterile equipment, management of soiled waste, dispensing of opioid replacement therapy [ Time Frame: day 1 ]
    yes/no

  3. Perception of the profile / behaviour of pharmacists: welcoming and open to discussion [ Time Frame: day 1 ]
    VAS, 0: not at all - 100 : totally

  4. Perception of the profile / behaviour of pharmacists: respect for confidentiality [ Time Frame: day 1 ]
    VAS, 0: not at all - 100 : totally

  5. Perception of the profile / behaviour of pharmacists: competent [ Time Frame: day 1 ]
    VAS, 0: not at all - 100 : totally

  6. opioid replacement therapy [ Time Frame: day 1 ]
    name, dose, route

  7. Number of physician consulted for the last 6 months [ Time Frame: day 1 ]
    number

  8. Number of community pharmacy consulted for the last 6 months [ Time Frame: day 1 ]
    number

  9. duration of opioid use disorder [ Time Frame: day 1 ]
    number of years/months

  10. Demographic information [ Time Frame: day 1 ]
    : age, sex, study level, marital status, health care insurance, monthly income, type of housing



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient undergoing opioid replacement therapy
Criteria

Inclusion Criteria:

  • Patient undergoing opioid replacement therapy

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961789


Contacts
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Contact: Lise Laclautre 334.73.754.963 promo_interne_drci@chu-clermontferrand.fr

Locations
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France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63000
Contact: Lise Laclautre    334.73.754.963    promo_interne_drci@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
UFR de Pharmacie (Clermont-Ferrand)
Investigators
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Principal Investigator: David Balayssac University Hospital, Clermont-Ferrand

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03961789     History of Changes
Other Study ID Numbers: CHU-434
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Clermont-Ferrand:
Opioid-Related Disorders
Opiate replacement therapy
Community Pharmacy Services
Patient Satisfaction

Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents