Viral Gastro EnteritisNCT02237573
Impact of Handing to Patients a Copy of the Consultation Report on Their Medicine Consumption
A study testing Written medical report and standardized medical advices in people with Viral Gastro Enteritis and Pharyngitis, run by University Paris 7 - Denis Diderot at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Viral Gastro Enteritis, Pharyngitis
- What is being tested?
- Written medical report and standardized medical advices
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All consecutive patients with >18 ans Diagnosis of gastroenteritis or rhinopharyngitis by the physician Written consent by patient
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Viral Gastro Enteritis, Pharyngitis
- Being tested
- Written medical report and standardized medical advices, Control
- Keywords
- general practice, viral infections, consultation reports, drug prescription
- Medical subject headings
- Pharyngitis, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written medical report and standardized medical advicesOther
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.
ControlOther
Other:
Oral standardized medical advices from evidence published in the literature. Physicians will be trained by a single investigator.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Written medical report and standardized medical advices Receives: Other: Written medical report and standardized medical advices |
| Control | Active comparator | Standardized medical advice only Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (4)
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.
Measured: 1 day
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.
Measured: 30 days
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
Measured: 30 days
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startDec 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Viral Gastro EnteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Paris 7 - Denis Diderot
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TRAN Viet thi, University Paris 7 - Denis Diderot
- Investigators
- Viet-Thi Tran, MD, Principal investigator, Paris Diderot University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237573
- Sponsor's protocol ID
- DMG003
- Status last verified
- Jun 2015
- First submitted
- 14 Aug 2014
- Last updated
- 22 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02237573
- Acronym / sponsor ID
- DMG003
- Conditions
- Viral Gastro Enteritis, Pharyngitis
- Keywords
- general practice, viral infections, consultation reports, drug prescription
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University Paris 7 - Denis DiderotUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 11 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Written medical report and standardized medical advicesWritten medical report and standardized medical advices |
| Control | Active comparator | Other: ControlStandardized medical advice only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All consecutive patients with >18 ans Diagnosis of gastroenteritis or rhinopharyngitis by the physician Written consent by patient
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Written medical report and standardized medical advicesThe 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 | Intervention |
| ControlOther: Oral standardized medical advices from evidence published in the literature. Physicians will be trained by a single investigator. | Other | Control |
Primary outcome
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.
4 secondary outcomes
Number (Proportion) of each class of prescribed drug
Time frame: 1 day
Number (Proportion) of reconsultation
Time frame: 30 days
Number (Proportion) of patients resorting to self-treatment
Time frame: 30 days
Number (Proportion) of adverse effects
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2015.
- Background: PubMed 11786454Macfarlane 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viet-Thi Tran, MD principal investigator
Paris Diderot University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written medical report and standardized medical advices in people with Viral Gastro Enteritis and Pharyngitis, run by University Paris 7 - Denis Diderot at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean number of medications prescribed by the physician (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02237573, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2015; AzTrials last refreshed its copy on 8 Nov 2026.