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Impact of Six Patient Information Leaflets (PIL) on Doctor Patient Communication (EDIFIP)

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ClinicalTrials.gov Identifier: NCT02246361
Recruitment Status : Completed
First Posted : September 22, 2014
Last Update Posted : August 27, 2015
Sponsor:
Collaborator:
Groupe Hospitalier Mutualiste de Grenoble
Information provided by (Responsible Party):
Floralis

Brief Summary:
The purpose of this "before-after" prospective multicenter study is to assess the impact of six Patient Information Leaflets (PILs) on Doctor Patient Communication scale (DPC) and adherence scale for common acute illnesses in emergency ward.

Condition or disease Intervention/treatment Phase
Ankle Sprain Infectious Colitis Diverticulitis Pyelonephritis Prostatitis Pneumonitis Procedure: Patient Information Leaflet (PIL) Phase 4

Detailed Description:

Assessing the impact of six Patient Information Leaflets (PILs) on Doctor Patient Communication scale (DPC) and adherence scale for common acute illnesses (infectious colitis, diverticulitis, pneumonitis, prostatitis, pyelonephritis , ankle sprain) in two emergency ward.

For "before" study without intervention : usual consultation without PIL .

For "after study" with intervention : the patient is given a PIL related to his disease during the consultation.

Data collection will take place the same day as the consultation by self-administered questionnaire for DPC scale and also between 7 to 10 days after the consultation by phone survey for DPC scale and adherence scale.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Impact of Six Patient Information Leaflets (PIL) on Doctor Patient Communication and Adherence in Emergency Ward
Study Start Date : September 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Arm Intervention/treatment
No Intervention: Phase 1 (without PIL)
No particular intervention during consultation for the patient
Experimental: Phase 2
Patient Information Leaflet is given to the patient during the consultation
Procedure: Patient Information Leaflet (PIL)
Patient Information Leaflet (PIL) about infectious colitis, diverticulitis, pneumonitis, prostatitis or either pyelonephritis is given to the patient related to his disease during the consultation




Primary Outcome Measures :
  1. Doctor Patient Communication score [ Time Frame: In seven to ten days after delivery ]
    All patients will be called seven to ten days after the delivery of a PIL during the visit to answer a questionnaire on their perception of Doctor Patient Communication (DPC) since they visit the GP. Il will permit to calculate a DPC score.


Secondary Outcome Measures :
  1. Adherence score [ Time Frame: In seven to ten days after the delivery ]
    All patients will be called seven to ten days after the delivery of a PIL during the visit, to answer a questionnaire on their adherence related to the disease since they visit the GP. Il will permit to calculate a adherence score.

  2. Satisfaction score [ Time Frame: In seven to ten days after the delivery ]
    All patients will be called seven to ten days after the visit, to answer a questionnaire on their satisfaction about since they visit the GP. Il will permit to calculate a satisfaction score.

  3. Doctor Patient Communication score [ Time Frame: Just after the visit ]
    All patients will answer to a self questionnaire on their perception of Doctor Patient Communication (DPC) just after the visit of the GP. Il will permit to calculate a DPC score.



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patient.
  • Minor aged over 15 years accompanied by a responsible adult.
  • The patient must be reachable by telephone within seven to ten days following the consultation.

Exclusion Criteria:

  • Illiterate patient.
  • Patient refusing follow-up call.
  • Patient with visual or hearing impairment.
  • Patient non-Francophone.
  • Private patient of liberty by judicial or administrative.
  • Person being a measure of legal protection.

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): NCT02246361


Locations
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France
Groupe Hospitalier Mutualiste, service des urgences
Grenoble, Isere, France, 38000
Centre Hospitalier
Chambery, Savoie, France, 74000
Sponsors and Collaborators
Floralis
Groupe Hospitalier Mutualiste de Grenoble
Investigators
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Principal Investigator: Melanie Sustersic, MD Floralis France

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Floralis
ClinicalTrials.gov Identifier: NCT02246361     History of Changes
Other Study ID Numbers: N°IRB 5891
First Posted: September 22, 2014    Key Record Dates
Last Update Posted: August 27, 2015
Last Verified: August 2015
Keywords provided by Floralis:
Ankle sprain
Infectious colitis
Diverticulitis
Pyelonephritis
Prostatitis
Pneumonitis
Patient Information Leaflet (PIL)
Doctor Patient Communication
Adherence
Satisfaction
Scale
Doctor Patient Communication scale
Adherence scale
Satisfaction scale
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Diverticulitis
Colitis
Pneumonia
Prostatitis
Pyelonephritis
Ankle Injuries
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Wounds and Injuries
Leg Injuries
Diverticular Diseases
Intraabdominal Infections
Prostatic Diseases
Genital Diseases, Male
Nephritis, Interstitial
Nephritis
Kidney Diseases
Urologic Diseases
Pyelitis
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections