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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Osteoarthritis

Intervention / Treatment
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* Other: free paracetamol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with osteoarthritis assisted by a General Practitioners working in Reggio Emilia Province who agreed to participate in the study

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: free paracetamol<br>the General Practitioners can prescribe paracetamol for free (covered by NHS). Patients can receive monthly dose at the local hospital | Other: free paracetamol<br>* General Practitioners can prescribe paracetamol and the patient had to pick up the drug at the local hospital.<br>|
| No Intervention: standard drug prescription<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consumption of NSAID | Difference in defined daily dose (DDD) per patient between the control and the intervention | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consumption of PPI | Difference in defined daily dose (DDD) per patient between the control and the intervention | one year | 
| Consumption of opioids | Difference in defined daily dose (DDD) per patient between the control and the intervention | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paracetamol, PPI, Opioids, NSAID, Drug Prescription