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

Pharyngitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02237573
• Other study ID #: DMG003
• Status: Completed
• Phase: N/A
• First received: August 14, 2014
• Last updated: June 19, 2015
• Start date: December 2014
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: University Paris 7 - Denis Diderot
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of HealthFrance: Ministère de l'Enseignement supérieur et de la Recherche
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenovirus Infections, Human
• Enteritis
• Enterovirus Infections
• Gastroenteritis
• Pharyngitis
• Respiratory Tract Infections
• Viral Gastro Enteritis

Intervention

Other:
• Written medical report and standardized medical advices
The intervention will include: 1) handing the patient at the end of the consultation a copy of the consultation report which will be composed of: a detailed report of the consultation (motive, case history, clinical examination, conclusion) written standardized medical advices from evidence published in the literature. Interventions will be designed by several general practitioners and tested by few patients.
• Control
Other: Oral standardized medical advices from evidence published in the literature. Physicians will be trained by a single investigator.

Locations

Country	Name	City	State
France	Faculté Xavier Bichat	Paris

Sponsors (1)

Lead Sponsor	Collaborator
University Paris 7 - Denis Diderot

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean number of medications prescribed by the physician	We will assess the mean number of medications prescribed by the physician during the consultation.; Two independent investigators will assess, aposteriori from medical records, each prescription to determine the number of prescribed drugs (including rhino pharyngeal desobstruction). In case of discrepancy in their assessments, a third investigator will help in consensus.	1 day	No
Secondary	Number (Proportion) of each class of prescribed drug	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.	1 day	No
Secondary	Number (Proportion) of reconsultation	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.	30 days	No
Secondary	Number (Proportion) of patients resorting to self-treatment	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	30 days	No
Secondary	Number (Proportion) of adverse effects	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.	30 days	Yes