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NCT Number: NCT02237573

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

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.

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Key information

Conditions

Viral Gastro Enteritis Infections Otorhinolaryngologic Diseases Pharyngeal Diseases Pharyngitis Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculté Xavier Bichat

Paris, 75018, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Written medical report and standardized medical advices

Other

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

Other:

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

Primary outcomes

  1. Mean number of medications prescribed by the physician

    Time frame: 1 day

    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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

University Paris 7 - Denis Diderot

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 11, 2014
Registry last updated
Jun 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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