- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05196386
Usual Care Intervention Research Evaluating the Impact of a Personalized Pharmaceutical Plan on the Duration of Opioid Treatment in Non-cancerous Pain (PPP-Care)
Many treatments with WHO grade III opioids are being introduced in the rheumatology department for non-cancerous pain. The duration of this treatment prescribed at discharge is often uncontrolled and sometimes leads to significant addiction.
The team at the local pain center recommends an average duration of 28 days for this type of pain. There is a full-time pharmacy intern in the rheumatology department.
The aim of this work is to evaluate the impact of a targeted pharmaceutical interview on the duration of the morphine treatment initiated during hospitalization.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Rouen, France
- Rouen University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18 and < 75 years old when entering the rheumatology department
- Hospitalization in the rheumatology department
- Patient with acute non-traumatic musculoskeletal disease
- Patient not taking grade III opioid treatment
- Patient affiliated to a social security scheme
- Patient having read and understood the information letter and signed the consent form
- Patient present on a day which the pharmacy intern is present
Exclusion Criteria:
- Presence of cancer, fibromyalgia, already diagnosed at inclusion
- Patient does not understand French
- Patient with Current or past opioid addiction
- Person deprived of liberty by administrative or judicial decision
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patient with targeted pharmaceutical interview
Specific information about treatment delivered by pharmacist
|
Previous treatment conciliation at hospital admission
Allocated treatment during hospital stay
Specific information about treatment delivered by pharmacist
|
|
Other: Patient without targeted pharmaceutical interview
No Specific information about treatment delivered by pharmacist
|
Previous treatment conciliation at hospital admission
Allocated treatment during hospital stay
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Total duration of opioid treatment
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rate of patients exceeding 28 days of cumulative duration of treatment
Time Frame: 6 months
|
6 months
|
|
Rate of patients exceeding 90 days of cumulative duration of treatment
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Olivier VITTECOQ, Pr, University Hospital, Rouen
- Principal Investigator: Remi VARIN, Pr, University Hospital, Rouen
- Principal Investigator: Catherine CHENAILLER, Dr, University Hospital, Rouen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2019/0025/HP
- 2019-A00515-52 (Other Identifier: ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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