Clinical Trial: Impact of Handing to Patients a Copy of the Consultation Report on Their Medicine Consumption

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Impact of Handing to Patients With Viral Gastroenteritis or Upper Respiratory Tract Infections a Copy of the Consultation Report on Their Medicine Consumption: a Randomized Controlled Trial

Brief Summary:

In France, patients with benign viral infections (ie: gastro enteritis and/or rhinopharyngitis, etc.) often receive several prescriptions from their doctors, although there is evidence that these medicines are not efficient.

We hypothesize that patients could be reassured by health advices, especially if they are written. In addition, we believe that doctors would feel less guilty for not prescribing drugs if they could hand written consultation reports to patients, in these situations.

We aim to assess the impact of handing to patients with viral gastroenteritis or upper respiratory tract infections, a copy of the consultation report on their medicine consumption.

Detailed Summary:

In France, 90% of General practitioners' (GPs) consultations end with prescription of drugs (versus only 43,2% in Netherlands). A french medical thesis published in 2013 showed that drugs prescriptions were not a priority for patients. Rather than medicine's prescription, patients preferred attentive listening associated with personalized advices from their GPs. Several studies also showed that a commercial relationship exists between doctors and patients. The prescription is like an exchange currency against the patient money.

We aim to assess the impact of handing to patients with viral gastroenteritis or upper respiratory tract infections, a copy of the consultation report on their medicine consumption.

Sponsor: University Paris 7 - Denis Diderot

Current Primary Outcome: Mean number of medications prescribed by the physician [ Time Frame: 1 day ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Number (Proportion) of each class of prescribed drug [ Time Frame: 1 day ]

  We will assess the frequency of each class of medications prescribed by the physician during the consultation.

  Classes will be: 1)paracetamol, 2)non steroidal anti inflammatory drug, 3)antibiotics, 4)physiological serum, 5)vasoconstrictor nasal spray, 6)oral spray, 7)cough syrup, 8)loperamide, 9)phloroglucinol, 10)antiemetic drugs, 11) antiseptic lozenges.

  Two independent investigators will assess each prescription made by physicians to determine the different prescribed drugs (including rhinopharyngeal desobstruction). In case of discrepancy in their assessments, a third investigator will help in consensus.

• Number (Proportion) of reconsultation [ Time Frame: 30 days ]

  A single investigator will recontact all included patients by telephone to assess if they reconsulted a doctor for the same motive in the period. If they cannot be contacted by phone, they will be contacted by e-mail. A second call will be done after 7 days in case they did not answer the first call.

  We will compare proportion of reconsultation between the two groups.

• Number (Proportion) of patients resorting to self-treatment [ Time Frame: 30 days ]

  A single investigator will recontact all included patients by telephone to assess if included patients self treated themselves using drugs they had at their disposal or using non prescription drugs. If they cannot be contacted by phone, they will be contacted by e-mail. A second call will be done after 7 days in case they did not answer the first call.

  We will compare proportion of self treatment between the two groups

• Number (Proportion) of adverse effects [ Time Frame: 30 days ]

  One investigator will assess, aposteriori from medical records, if patients reconsulted for a motive that could be associated with an aggravation of the viral infection (gastro enteritis or rhinopharyngitis).

  In addition, all included patients will be recontacted by telephone (or e-mail in case they do not answer the phone) We will assess nature and number of cases.

Original Secondary Outcome: Same as current

Information By: University Paris 7 - Denis Diderot

Dates:
Date Received: August 14, 2014
Date Started: December 2014
Date Completion:
Last Updated: June 19, 2015
Last Verified: June 2015