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CompletedNCT02237573Updated Jun 22, 2015

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

An interventional study of Written medical report and standardized medical advices and Control in Viral Gastro Enteritis and Pharyngitis, sponsored by University Paris 7 - Denis Diderot. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-22.

Sponsored by University Paris 7 - Denis Diderot · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Viral Gastro Enteritis
  • Pharyngitis

Keywords

  • general practice
  • viral infections
  • consultation reports
  • drug prescription
03

In context

Pharyngitis

226 studies on the registry are indexed under Pharyngitis; 35 are open to participants now.

This study's enrollment of 75 is below the median of 144 across 188 interventional studies indexed under Pharyngitis.

Browse Pharyngitis studies →

Lead sponsor

University Paris 7 - Denis Diderot is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
75 participants (actual)

Study arms

  • Experimental
    Intervention

    Written medical report and standardized medical advices

    Other: Written medical report and standardized medical advices

  • Active comparator
    Control

    Standardized medical advice only

    Other: Control

Interventions

  • OtherWritten 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: 1. a detailed report of the consultation (motive, case history, clinical examination, conclusion) 2. written standardized medical advices from evidence published in the literature. Interventions will be designed by several general practitioners and tested by few patients.

  • OtherControl

    Other: Oral standardized medical advices from evidence published in the literature. Physicians will be trained by a single investigator.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day

Secondary outcomes

  1. 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.

    Time frame: 1 day

  2. 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.

    Time frame: 30 days

  3. 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

    Time frame: 30 days

  4. 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.

    Time frame: 30 days

07

Study locations

1 site
  • Faculté Xavier Bichat
    Paris, 75018, France
08

References and documents

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. PubMed 11786454 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02237573
Lead sponsor
University Paris 7 - Denis Diderot
Responsible party
TRAN Viet thi (assistant professor, University Paris 7 - Denis Diderot) — Principal investigator
First posted
Sep 11, 2014
Start date
Dec 2014
Primary completion
May 2015
Completion
May 2015
Last update
Jun 22, 2015

Study contacts

Viet-Thi Tran, MD
principal investigator · Paris Diderot University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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