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

Primary Purpose

Viral Gastro Enteritis, Pharyngitis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Written medical report and standardized medical advices
Control
Sponsored by
University Paris 7 - Denis Diderot
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Viral Gastro Enteritis focused on measuring general practice, viral infections, consultation reports, drug prescription

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculté Xavier Bichat

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Written medical report and standardized medical advices

Standardized medical advice only

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
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.

Full Information

First Posted
August 14, 2014
Last Updated
June 19, 2015
Sponsor
University Paris 7 - Denis Diderot
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1. Study Identification

Unique Protocol Identification Number
NCT02237573
Brief Title
Impact of Handing to Patients a Copy of the Consultation Report on Their Medicine Consumption
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 Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Paris 7 - Denis Diderot

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Viral Gastro Enteritis, Pharyngitis
Keywords
general practice, viral infections, consultation reports, drug prescription

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Written medical report and standardized medical advices
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Standardized medical advice only
Intervention Type
Other
Intervention Name(s)
Written medical report and standardized medical advices
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Other: Oral standardized medical advices from evidence published in the literature. Physicians will be trained by a single investigator.
Primary Outcome Measure Information:
Title
Mean number of medications prescribed by the physician
Description
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 Outcome Measure Information:
Title
Number (Proportion) of each class of prescribed drug
Description
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
Title
Number (Proportion) of reconsultation
Description
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
Title
Number (Proportion) of patients resorting to self-treatment
Description
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
Title
Number (Proportion) of adverse effects
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Viet-Thi Tran, MD
Organizational Affiliation
Paris Diderot University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculté Xavier Bichat
City
Paris
ZIP/Postal Code
75018
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
11786454
Citation
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.
Results Reference
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Impact of Handing to Patients a Copy of the Consultation Report on Their Medicine Consumption

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