AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

France1 site
  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63000

Other trials in France

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.

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 groups in NCT03961789
Study groupRoleWhat they receive
cohorte 1patients 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.

  1. 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)
  1. Prevention tips given by the pharmacist: risk of infection, overdose, way of using drugs, adverse effects and drug interactions

    yes/no

    Measured: day 1

  2. Services rendered by the pharmacist: sale of sterile equipment, management of soiled waste, dispensing of opioid replacement therapy

    yes/no

    Measured: day 1

  3. Perception of the profile / behaviour of pharmacists: welcoming and open to discussion

    VAS, 0: not at all - 100 : totally

    Measured: day 1

  4. Perception of the profile / behaviour of pharmacists: respect for confidentiality

    VAS, 0: not at all - 100 : totally

    Measured: day 1

  5. Perception of the profile / behaviour of pharmacists: competent

    VAS, 0: not at all - 100 : totally

    Measured: day 1

  6. opioid replacement therapy

    name, dose, route

    Measured: day 1

  7. Number of physician consulted for the last 6 months

    number

    Measured: day 1

  8. Number of community pharmacy consulted for the last 6 months

    number

    Measured: day 1

  9. duration of opioid use disorder

    number of years/months

    Measured: day 1

  10. 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.

  1. First posted23 May 2019
  2. Study start29 Jan 2018
  3. Primary completion21 May 2019
  4. Study completion21 May 2019

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in