PPPCARE II: Impact of a Personalized Medication Plan on Duration of Treatment With Potent Opioids in Acute Non-cancer Musculoskeletal Pain.

Sponsor
University Hospital, Rouen (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05905146
Collaborator
(none)
200
2
30

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate whether patients who benefit from a personalized pharmaceutical plan (PPP) during their hospitalization, allowing them to be informed and sensitized, are treated for a shorter period of time with strong opioids with a reduced risk of dependence compared to a management according to the usual modalities in the rheumatology services concerned.

Condition or Disease Intervention/Treatment Phase
  • Other: personalized pharmaceutical plan
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Impact of a Personalized Medication Plan on Duration of Treatment With Potent Opioids in Acute Non-cancer Musculoskeletal Pain. Multicenter, Randomized, Controlled Study
Anticipated Study Start Date :
Sep 15, 2023
Anticipated Primary Completion Date :
Mar 15, 2026
Anticipated Study Completion Date :
Mar 15, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: interventional group

benefiting from a multi-professional intervention around the strong opioid treatment with the aim of setting up a personalized pharmaceutical plan

Other: personalized pharmaceutical plan
multi-professional intervention around strong opioid treatment with targeted pharmaceutical interview

No Intervention: control group

routine management, including medication reconciliation at entry and exit and pharmaceutical analysis of prescriptions

Outcome Measures

Primary Outcome Measures

  1. total duration of treatment in days with strong opioids from day of inclusion [6 months]

Secondary Outcome Measures

  1. number of patients exceeding the optimal duration of treatment with strong opioids defined by the SFETD learned society (French Society for the Study and Treatment of Pain) (3 months) [3 months]

  2. pain assessment (numerical scale) at first patient call after stopping strong opioids [6 months]

  3. number of patients exceeding the optimal duration of treatment with strong opioids defined by the CLUD (Pain Control Committee) of Rouen University Hospital (28 days) [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patient hospitalized in the rheumatology department

  • Patient with acute pain in the context of a non-cancerous, non-traumatic, high-energy musculoskeletal pathology

  • Patient for whom a prescription of strong opioid derivatives is initiated in rheumatology or patient for whom a prescription of strong opioid derivatives is maintained in rheumatology if the initial prescription has a maximum duration of 30 consecutive days prior to inclusion

Exclusion Criteria:
  • Patient with cancer or fibromyalgia already diagnosed at inclusion

  • Patient with poor French language skills

  • Taking a strong opioid treatment for more than 30 consecutive days prior to inclusion

  • Person judged by the prescriber or pharmacist as not autonomous for the management of strong opioid treatment

  • Patient already included in the study

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Rouen

Investigators

  • Principal Investigator: Catherine CHENAILLER, Rouen University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT05905146
Other Study ID Numbers:
  • 2020/0426/HP
First Posted:
Jun 15, 2023
Last Update Posted:
Jun 15, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 15, 2023