Clinical trial NCT02237573: Impact of Handing to Patients a Copy of the Consultation Report on Their Medicine Consumption
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Viral Gastro Enteritis
Pharyngitis
Keywords: general practice
viral infections
consultation reports
drug prescription
Lead sponsor: University Paris 7 - Denis Diderot
Sponsor class: OTHER
First posted: 2014-09-11
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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.

Eligibility criteria: Inclusion Criteria:

All consecutive patients with \>18 ans Diagnosis of gastroenteritis or rhinopharyngitis by the physician Written consent by patient

Exclusion Criteria:

Patients who have already visited the doctor in the last 15 days A given patient can only be included once Diagnostic uncertainty or need of laboratory tests Cognitive impairment Only one patient by family or visit

Primary outcomes:
measure: Mean number of medications prescribed by the physician
timeFrame: 1 day
Secondary outcomes:
measure: Number (Proportion) of each class of prescribed drug
timeFrame: 1 day
measure: Number (Proportion) of reconsultation
timeFrame: 30 days
measure: Number (Proportion) of patients resorting to self-treatment
timeFrame: 30 days
measure: Number (Proportion) of adverse effects
timeFrame: 30 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Faculté Xavier Bichat
Study officials:
affiliation: Paris Diderot University
name: Viet-Thi Tran, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Macfarlane J, Holmes W, Gard P, Thornhill D, Macfarlane R, Hubbard R. Reducing antibiotic use for acute bronchitis in primary care: blinded, randomised controlled trial of patient information leaflet. BMJ. 2002 Jan 12;324(7329):91-4. doi: 10.1136/bmj.324.7329.91.