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

Primary Purpose

Acute Pathology of the Locomotor System

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
personalized pharmaceutical plan
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acute Pathology of the Locomotor System

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    interventional group

    control group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    total duration of treatment in days with strong opioids from day of inclusion

    Secondary Outcome Measures

    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)
    pain assessment (numerical scale) at first patient call after stopping strong opioids
    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)

    Full Information

    First Posted
    May 23, 2023
    Last Updated
    June 14, 2023
    Sponsor
    University Hospital, Rouen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05905146
    Brief Title
    Impact of a Personalized Medication Plan on Duration of Treatment With Potent Opioids in Acute Non-cancer Musculoskeletal Pain.
    Acronym
    PPPCARE II
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 15, 2023 (Anticipated)
    Primary Completion Date
    March 15, 2026 (Anticipated)
    Study Completion Date
    March 15, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Rouen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Pathology of the Locomotor System

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    interventional group
    Arm Type
    Experimental
    Arm Description
    benefiting from a multi-professional intervention around the strong opioid treatment with the aim of setting up a personalized pharmaceutical plan
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    routine management, including medication reconciliation at entry and exit and pharmaceutical analysis of prescriptions
    Intervention Type
    Other
    Intervention Name(s)
    personalized pharmaceutical plan
    Intervention Description
    multi-professional intervention around strong opioid treatment with targeted pharmaceutical interview
    Primary Outcome Measure Information:
    Title
    total duration of treatment in days with strong opioids from day of inclusion
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    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)
    Time Frame
    3 months
    Title
    pain assessment (numerical scale) at first patient call after stopping strong opioids
    Time Frame
    6 months
    Title
    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)
    Time Frame
    28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Catherine CHENAILLER
    Phone
    +3323288
    Ext
    82.07
    Email
    catherine.chenailler@chu-rouen.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Armelle GUIDOTTI
    Phone
    +3323288
    Ext
    8265
    Email
    armelle.guidotti@chu-rouen.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Catherine CHENAILLER
    Organizational Affiliation
    Rouen University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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