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

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

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.

Study Overview

• Status: Completed
• Conditions: Pharyngitis; Viral Gastro Enteritis
• Intervention / Treatment: Other: Written medical report and standardized medical advices; Other: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75018
    • Faculté Xavier Bichat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Written medical report and standardized medical advices	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.
Active Comparator: Control; Standardized medical advice only	Other: Control; Other: Oral standardized medical advices from evidence published in the literature. Physicians will be trained by a single investigator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University Paris 7 - Denis Diderot
• Investigators: Principal Investigator: Viet-Thi Tran, MD, Paris Diderot University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: August 14, 2014
• First Submitted That Met QC Criteria: September 9, 2014
• First Posted (Estimate): September 11, 2014

Study Record Updates

• Last Update Posted (Estimate): June 22, 2015
• Last Update Submitted That Met QC Criteria: June 19, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: general practice; viral infections; consultation reports; drug prescription
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Intestinal Diseases; Gastroenteritis; Enteritis; Pharyngitis
• Other Study ID Numbers: DMG003