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

19 juni 2015 uppdaterad av: TRAN Viet thi, University Paris 7 - Denis Diderot

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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

75

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Paris, Frankrike, 75018
        • Faculté Xavier Bichat

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Intervention
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.
Aktiv komparator: Control
Standardized medical advice only

Other:

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mean number of medications prescribed by the physician
Tidsram: 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.

1 day

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number (Proportion) of each class of prescribed drug
Tidsram: 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.

1 day
Number (Proportion) of reconsultation
Tidsram: 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.

30 days
Number (Proportion) of patients resorting to self-treatment
Tidsram: 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

30 days
Number (Proportion) of adverse effects
Tidsram: 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.

30 days

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Viet-Thi Tran, MD, Paris diderot University

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 december 2014

Primärt slutförande (Faktisk)

1 maj 2015

Avslutad studie (Faktisk)

1 maj 2015

Studieregistreringsdatum

Först inskickad

14 augusti 2014

Först inskickad som uppfyllde QC-kriterierna

9 september 2014

Första postat (Uppskatta)

11 september 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

22 juni 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 juni 2015

Senast verifierad

1 juni 2015

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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