Impact of Handing to Patients a Copy of the Consultation Report on Their Medicine Consumption
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2014
CompletedFirst Posted
Study publicly available on registry
September 11, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedJune 22, 2015
June 1, 2015
5 months
August 14, 2014
June 19, 2015
Conditions
Keywords
Outcome Measures
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.
1 day
Secondary Outcomes (4)
Number (Proportion) of each class of prescribed drug
1 day
Number (Proportion) of reconsultation
30 days
Number (Proportion) of patients resorting to self-treatment
30 days
Number (Proportion) of adverse effects
30 days
Study Arms (2)
Intervention
EXPERIMENTALWritten medical report and standardized medical advices
Control
ACTIVE COMPARATORStandardized medical advice only
Interventions
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.
Other: Oral standardized medical advices from evidence published in the literature. Physicians will be trained by a single investigator.
Eligibility Criteria
You may qualify if:
- All consecutive patients with \>18 ans Diagnosis of gastroenteritis or rhinopharyngitis by the physician Written consent by patient
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculté Xavier Bichat
Paris, 75018, France
Related Publications (1)
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.
PMID: 11786454BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Viet-Thi Tran, MD
Paris Diderot University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
August 14, 2014
First Posted
September 11, 2014
Study Start
December 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
June 22, 2015
Record last verified: 2015-06