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

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ClinicalTrials.gov Identifier: NCT02237573
Recruitment Status : Completed
First Posted : September 11, 2014
Last Update Posted : June 22, 2015
Sponsor:
Information provided by (Responsible Party):
TRAN Viet thi, University Paris 7 - Denis Diderot

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.


Condition or disease Intervention/treatment Phase
Viral Gastro Enteritis Pharyngitis Other: Written medical report and standardized medical advices Other: Control Not Applicable

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  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gastroenteritis

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:

  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.

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.





Primary Outcome Measures :
  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 Outcome Measures :
  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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02237573


Locations
France
Faculté Xavier Bichat
Paris, France, 75018
Sponsors and Collaborators
University Paris 7 - Denis Diderot
Investigators
Principal Investigator: Viet-Thi Tran, MD Paris Diderot University

Publications:
Responsible Party: TRAN Viet thi, assistant professor, University Paris 7 - Denis Diderot
ClinicalTrials.gov Identifier: NCT02237573     History of Changes
Other Study ID Numbers: DMG003
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: June 22, 2015
Last Verified: June 2015

Keywords provided by TRAN Viet thi, University Paris 7 - Denis Diderot:
general practice
viral infections
consultation reports
drug prescription

Additional relevant MeSH terms:
Respiratory Tract Infections
Pharyngitis
Enteritis
Gastroenteritis
Infection
Respiratory Tract Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases