Opioid-Related DisordersSATISFYNCT03961789
Assessment of the Satisfaction of Patient Undergoing Opioid Replacement Therapy Toward Their Management in Community Pharmacy
An observational study of Opioid-Related Disorders, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-Related Disorders
- What is being tested?
- patients undergoing opioid replacement therapy
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jan 2018to 21 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient undergoing opioid replacement therapy
Who may be able to join
- Patient undergoing opioid replacement therapy
Who cannot join
- Age <18 years
- Patient unable to understand or write in French
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Opioid-Related Disorders
- Being tested
- patients undergoing opioid replacement therapy
- Keywords
- Opioid-Related Disorders, Opiate replacement therapy, Community Pharmacy Services, Patient Satisfaction
- Medical subject headings
- Opioid-Related Disorders, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients undergoing opioid replacement therapyOther
Also called no intervention or other
patients undergoing opioid replacement therapy
| Study group | Role | What they receive |
|---|---|---|
| cohorte 1 | patients undergoing opioid replacement therapy Receives: Other: patients undergoing opioid replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of satisfaction
visual analogic scale (VAS) "Are you satisfied with your management by community pharmacists?" 0: not satisfied - 100: totally satisfied
Measured: day 1
Secondary outcomes (10)
Prevention tips given by the pharmacist: risk of infection, overdose, way of using drugs, adverse effects and drug interactions
yes/no
Measured: day 1
Services rendered by the pharmacist: sale of sterile equipment, management of soiled waste, dispensing of opioid replacement therapy
yes/no
Measured: day 1
Perception of the profile / behaviour of pharmacists: welcoming and open to discussion
VAS, 0: not at all - 100 : totally
Measured: day 1
Perception of the profile / behaviour of pharmacists: respect for confidentiality
VAS, 0: not at all - 100 : totally
Measured: day 1
Perception of the profile / behaviour of pharmacists: competent
VAS, 0: not at all - 100 : totally
Measured: day 1
opioid replacement therapy
name, dose, route
Measured: day 1
Number of physician consulted for the last 6 months
number
Measured: day 1
Number of community pharmacy consulted for the last 6 months
number
Measured: day 1
duration of opioid use disorder
number of years/months
Measured: day 1
Demographic information
: age, sex, study level, marital status, health care insurance, monthly income, type of housing
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start29 Jan 2018
- Primary completion21 May 2019
- Study completion21 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- UFR de Pharmacie (Clermont-Ferrand)
- Responsible party
- Sponsor
- Investigators
- David Balayssac, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03961789
- Sponsor's protocol ID
- CHU-434
- Acronym
- SATISFY
- Status last verified
- Dec 2021
- First submitted
- 22 May 2019
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Satisfaction of Patient Undergoing Opioid Replacement Therapy Toward Their Management in Community Pharmacy - SATISFY: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03961789
- Acronym / sponsor ID
- SATISFY / CHU-434
- Conditions
- Opioid-Related Disorders
- Keywords
- Opioid-Related Disorders, Opiate replacement therapy, Community Pharmacy Services, Patient Satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- UFR de Pharmacie (Clermont-Ferrand)
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 21 May 2019 (actual)
- Study completion
- 21 May 2019 (actual)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohorte 1 | – | Other: patients undergoing opioid replacement therapypatients undergoing opioid replacement therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient undergoing opioid replacement therapy
Key inclusion criteria (1 listed)
- Patient undergoing opioid replacement therapy
Key exclusion criteria (2 listed)
- Age <18 years
- Patient unable to understand or write in French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patients undergoing opioid replacement therapyAlso: no intervention or otherpatients undergoing opioid replacement therapy | Other | cohorte 1 |
Primary outcome
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
10 secondary outcomes
Prevention tips given by the pharmacist: risk of infection, overdose, way of using drugs, adverse effects and drug interactions
Time frame: day 1
Services rendered by the pharmacist: sale of sterile equipment, management of soiled waste, dispensing of opioid replacement therapy
Time frame: day 1
Perception of the profile / behaviour of pharmacists: welcoming and open to discussion
Time frame: day 1
Perception of the profile / behaviour of pharmacists: respect for confidentiality
Time frame: day 1
Perception of the profile / behaviour of pharmacists: competent
Time frame: day 1
opioid replacement therapy
Time frame: day 1
Number of physician consulted for the last 6 months
Time frame: day 1
Number of community pharmacy consulted for the last 6 months
Time frame: day 1
duration of opioid use disorder
Time frame: day 1
Demographic information
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Balayssac principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid-Related Disorders, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of satisfaction (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.