InterviewsOPI-HOMENCT07049796
Impact of a Pharmaceutical Interview at the Initiation of Opioid Treatment for Acute Non-cancer Pain
An observational study of Interviews, run by University Hospital, Rouen at 1 site in France.
Trial summary
In adult emergency departments, the number of admissions for adverse effects related to opioid use is constantly increasing. However, the massive flow of patients, lack of time, and rapid rotation of physicians in this department do not favor the transmission of in-depth information on the proper use of these… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interviews
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 12 Oct 2021to 31 May 2025
- How long will I take part?
- 9 Days
- 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: Consecutive patients over 18 years of age with opioid analgesic treatment upon discharge from hospital
Who may be able to join
- Adult patient (>18 years old)
- Patient admitted to the following departments: Downstream Hospitalization Unit (UHA) and Short-Term Hospitalization Unit (UHCD)
- Independent patient or assisted by close family (who can receive information with the patient)
- Initiation of opioid treatment for acute non-cancer pain during their stay in the Emergency Department, UHA, or UHCD or shortly before (<7 days)
- Patient speaks French
- Presence of the clinical pharmacist in the relevant departments
Who cannot join
- Patient with drug addiction
- Patient under guardianship/guardianship
- Patient transferred to rheumatology
- Patient already on opioid treatment for ≥ 7 days
- Patient refuses
- Patient assisted by a nurse at home or a caregiver not present during hospitalization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Pharmaceutical Interview on the Initiation of Opioid Treatment for Acute Non-cancer Pain in Short Stay Hospitalization Units (UHCD) and Downstream Hospitalization Units (UHA) of Adult Emergency Departments
In adult emergency departments, the number of admissions for adverse effects related to opioid use is constantly increasing. However, the massive flow of patients, lack of time, and rapid rotation of physicians in this department do not favor the transmission of in-depth information on the proper use of these therapies to the patient. In addition, this therapeutic class tends to worry patients. Public authorities as well as the medical profession are concerned about the potential adverse effects of morphine, but also the potential misuse, or even overdose, which can be fatal for the patient. Interventions by the community pharmacist in the fight against this misuse seem interesting, but an intervention upstream of potential problems of proper use seems even more relevant to us. Recent studies have shown the strong interest of the pharmacist in a multidisciplinary team on pain and opioids, both at the local level with studies conducted at the Rouen University Hospital by C. LATTARD et al. in rheumatology and E.BARAT et al. in outpatient surgery. It also appears that knowledge on the subject is satisfactory. Work conducted by Winstanley et al. shows that the intervention of a pharmacist in the emergency department seems relevant in terms of patient knowledge and satisfaction, and entirely feasible.
Read the detailed description
This study aims to measure the clinical impact of a hospital pharmacist when initiating opioid treatment for acute non-cancer pain in the Short Stay Hospitalization Units (UHCD) and Downstream Hospitalization Units (UHA) of the adult emergency department at Rouen University Hospital.
Pharmacy interviews will be offered to patients meeting the inclusion criteria. These 15- to 30-minute interviews will aim to present the tools implemented by the Rouen University Hospital pharmacy team. Several topics will be discussed, including: treatment optimization, potential adverse effects and what to do if they occur, the differences between immediate-release (IR) and extended-release (LP) forms, what to do if a dose is missed, the risks of overdose and addiction, and storage methods.
The objective of this project is, firstly, to improve patient satisfaction with their care and, secondly, to better understand the treatment, thus enabling more optimal use.
- Conditions
- Interviews
- Keywords
- Impact and feasibility of a pharmaceutical interview, opioid treatment
- Medical subject headings
- Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prospective cohort including patients with opioid analgesic treatment upon discharge from hospital | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of satisfaction with a pharmaceutical interview for acute pain
To assess satisfaction with pharmaceutical care for acute non-cancer pain in short-term hospitalization units (UHCD) and emergency downstream hospitalization units (UHA) during a telephone call to the patient 7 days after discharge from hospital. This satisfaction will be quantified as a percentage from 0 to 100%.
Measured: Day 7
Secondary outcomes (2)
Evaluation of the relevance and effectiveness of pharmaceutical maintenance against pain
Patient satisfaction with pharmaceutical pain management on day 3 will be assessed during a telephone call to the patient 3 days after discharge from hospital. This satisfaction will be quantified as a percentage from 0 to 100%.
Measured: Day 3
Evaluation of the relevance and effectiveness of pharmaceutical maintenance against pain
The average pain assessment on admission, discharge, day 3 and day 7 will be evaluated using a numerical scale from 0 to 10.
Measured: Day 3 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start12 Oct 2021
- Primary completion30 Nov 2024
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InterviewsStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 9 Days
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johanna JR RAYMOND, Doctor, Study director, University Rouen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049796
- Sponsor's protocol ID
- 2021/152/OB
- Other IDs
- N° IDRCB : 2021-A01246-35
- Acronym
- OPI-HOME
- Status last verified
- Jan 2025
- First submitted
- 25 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data provided will be the property of the sponsor and will be used solely for its own research activities.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Pharmaceutical Interview on the Initiation of Opioid Treatment for Acute Non-cancer Pain in Short Stay Hospitalization Units (UHCD) and Downstream Hospitalization Units (UHA) of Adult Emergency Departments
- ClinicalTrials.gov ID
- NCT07049796
- Acronym / sponsor ID
- OPI-HOME / 2021/152/OB
- Conditions
- Interviews
- Keywords
- Impact and feasibility of a pharmaceutical interview, opioid treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 3 Jul 2025 (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.
In adult emergency departments, the number of admissions for adverse effects related to opioid use is constantly increasing. However, the massive flow of patients, lack of time, and rapid rotation of physicians in this department do not favor the transmission of in-depth information on the proper use of these therapies to the patient. In addition, this therapeutic class tends to worry patients. Public authorities as well as the medical profession are concerned about the potential adverse effects of morphine, but also the potential misuse, or even overdose, which can be fatal for the patient. Interventions by the community pharmacist in the fight against this misuse seem interesting, but an intervention upstream of potential problems of proper use seems even more relevant to us. Recent studies have shown the strong interest of the pharmacist in a multidisciplinary team on pain and opioids, both at the local level with studies conducted at the Rouen University Hospital by C. LATTARD et al. in rheumatology and E.BARAT et al. in outpatient surgery. It also appears that knowledge on the subject is satisfactory. Work conducted by Winstanley et al. shows that the intervention of a pharmacist in the emergency department seems relevant in terms of patient knowledge and satisfaction, and entirely feasible.
Detailed description
This study aims to measure the clinical impact of a hospital pharmacist when initiating opioid treatment for acute non-cancer pain in the Short Stay Hospitalization Units (UHCD) and Downstream Hospitalization Units (UHA) of the adult emergency department at Rouen University Hospital.
Pharmacy interviews will be offered to patients meeting the inclusion criteria. These 15- to 30-minute interviews will aim to present the tools implemented by the Rouen University Hospital pharmacy team. Several topics will be discussed, including: treatment optimization, potential adverse effects and what to do if they occur, the differences between immediate-release (IR) and extended-release (LP) forms, what to do if a dose is missed, the risks of overdose and addiction, and storage methods.
The objective of this project is, firstly, to improve patient satisfaction with their care and, secondly, to better understand the treatment, thus enabling more optimal use.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 9 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort including patients with opioid analgesic treatment upon discharge from hospital | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients over 18 years of age with opioid analgesic treatment upon discharge from hospital
Key inclusion criteria (6 listed)
- Adult patient (>18 years old)
- Patient admitted to the following departments: Downstream Hospitalization Unit (UHA) and Short-Term Hospitalization Unit (UHCD)
- Independent patient or assisted by close family (who can receive information with the patient)
- Initiation of opioid treatment for acute non-cancer pain during their stay in the Emergency Department, UHA, or UHCD or shortly before (<7 days)
- Patient speaks French
Key exclusion criteria (6 listed)
- Patient with drug addiction
- Patient under guardianship/guardianship
- Patient transferred to rheumatology
- Patient already on opioid treatment for ≥ 7 days
- Patient refuses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of satisfaction with a pharmaceutical interview for acute pain
Time frame: Day 7
To assess satisfaction with pharmaceutical care for acute non-cancer pain in short-term hospitalization units (UHCD) and emergency downstream hospitalization units (UHA) during a telephone call to the patient 7 days after discharge from hospital. This satisfaction will be quantified as a percentage from 0 to 100%.
2 secondary outcomes
Evaluation of the relevance and effectiveness of pharmaceutical maintenance against pain
Time frame: Day 3
Evaluation of the relevance and effectiveness of pharmaceutical maintenance against pain
Time frame: Day 3 and Day 7
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 3 Jul 2025.
- Individual participant dataSharing planned: No. The data provided will be the property of the sponsor and will be used solely for its own research activities.
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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.
Johanna JR RAYMOND, Doctor study director
University Rouen Hospital
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 Interviews, run by University Hospital, Rouen 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 6 inclusion and 6 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 3 Jul 2025. 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?
Evaluation of satisfaction with a pharmaceutical interview for acute pain (time frame: Day 7). 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 3 Jul 2025.