search
Back to results

Impact of a Free Distribution of Paracetamol to Osteoarthritic Patients on Non-steroidal Anti-inflammatory Drugs (NSAID) and Proton Pump Inhibitors (PPI) Prescription

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
free paracetamol
Sponsored by
Azienda Unità Sanitaria Locale Reggio Emilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Osteoarthritis focused on measuring Paracetamol, PPI, Opioids, NSAID, Drug Prescription

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with osteoarthritis assisted by a General Practitioners working in Reggio Emilia Province who agreed to participate in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    free paracetamol

    standard drug prescription

    Arm Description

    the General Practitioners can prescribe paracetamol for free (covered by NHS). Patients can receive monthly dose at the local hospital

    Paracetamol is not included in the list of drugs than can be prescribed in charge of National Health System by General Practitioners. The General Practitioners can prescribe other drugs or recommend paracetamol payed by the patient (out of pocket) at the chemistry.

    Outcomes

    Primary Outcome Measures

    Consumption of NSAID
    Difference in defined daily dose (DDD) per patient between the control and the intervention

    Secondary Outcome Measures

    Consumption of PPI
    Difference in defined daily dose (DDD) per patient between the control and the intervention
    Consumption of opioids
    Difference in defined daily dose (DDD) per patient between the control and the intervention

    Full Information

    First Posted
    February 18, 2016
    Last Updated
    February 24, 2016
    Sponsor
    Azienda Unità Sanitaria Locale Reggio Emilia
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02691754
    Brief Title
    Impact of a Free Distribution of Paracetamol to Osteoarthritic Patients on Non-steroidal Anti-inflammatory Drugs (NSAID) and Proton Pump Inhibitors (PPI) Prescription
    Official Title
    A Cluster Randomised Trial to Measure the Impact of a Free Distribution of Paracetamol to Osteoarthritic Patients on Non-steroidal Anti-inflammatory Drugs (NSAID) and Proton Pump Inhibitors (PPI) Prescription
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2012 (undefined)
    Primary Completion Date
    October 2013 (Actual)
    Study Completion Date
    November 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Azienda Unità Sanitaria Locale Reggio Emilia

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Paracetamol is recommended as first line treatment for pain control in osteoarthritis, but it is not included in list of drugs than can be prescribed in charge of National Health System by General Practitioners. The hypothesis is that removing this economical barrier the investigators can decrease the prescription of NSAID and of the Proton Pump Inhibitors (PPI), often given for gastric bleeding prophylaxis in NSAID chronic users. As secondary outcome, opioids use was also monitored to see. Aim of the study is to test if allowing prescription of free paracetamol decreases the prescription of NSAID in osteoarthritic patients.
    Detailed Description
    The trial was conducted in two primary care units of the province of Reggio Emilia. The units have about 34.000 inhabitants. In this units 16 General Practitioners are active, the average beneficiaries per General Practitioner are 1500, about one fourth over 65 years old.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis
    Keywords
    Paracetamol, PPI, Opioids, NSAID, Drug Prescription

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    free paracetamol
    Arm Type
    Experimental
    Arm Description
    the General Practitioners can prescribe paracetamol for free (covered by NHS). Patients can receive monthly dose at the local hospital
    Arm Title
    standard drug prescription
    Arm Type
    No Intervention
    Arm Description
    Paracetamol is not included in the list of drugs than can be prescribed in charge of National Health System by General Practitioners. The General Practitioners can prescribe other drugs or recommend paracetamol payed by the patient (out of pocket) at the chemistry.
    Intervention Type
    Other
    Intervention Name(s)
    free paracetamol
    Intervention Description
    General Practitioners can prescribe paracetamol and the patient had to pick up the drug at the local hospital.
    Primary Outcome Measure Information:
    Title
    Consumption of NSAID
    Description
    Difference in defined daily dose (DDD) per patient between the control and the intervention
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    Consumption of PPI
    Description
    Difference in defined daily dose (DDD) per patient between the control and the intervention
    Time Frame
    one year
    Title
    Consumption of opioids
    Description
    Difference in defined daily dose (DDD) per patient between the control and the intervention
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with osteoarthritis assisted by a General Practitioners working in Reggio Emilia Province who agreed to participate in the study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alessandra Ferretti, MSc
    Organizational Affiliation
    Inter-Institutional Pharmaceutical Department, Local Health Authority, Reggio Emilia, Italy
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31810456
    Citation
    Vicentini M, Mancuso P, Giorgi Rossi P, Di Pede S, Pellati M, Gandolfi A, Zoboli D, Ricco D, Busani C, Ferretti A. A cluster randomized trial to measure the impact on nonsteroidal anti-inflammatory drug and proton pump inhibitor prescribing in Italy of distributing cost-free paracetamol to osteoarthritic patients. BMC Fam Pract. 2019 Dec 6;20(1):169. doi: 10.1186/s12875-019-1050-4.
    Results Reference
    derived

    Learn more about this trial

    Impact of a Free Distribution of Paracetamol to Osteoarthritic Patients on Non-steroidal Anti-inflammatory Drugs (NSAID) and Proton Pump Inhibitors (PPI) Prescription

    We'll reach out to this number within 24 hrs