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

Primary Purpose

Ankle Sprain, Infectious Colitis, Diverticulitis

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Patient Information Leaflet (PIL)
Sponsored by
Floralis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ankle Sprain focused on measuring 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

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Groupe Hospitalier Mutualiste, service des urgences
  • Centre Hospitalier

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Phase 1 (without PIL)

Phase 2

Arm Description

No particular intervention during consultation for the patient

Patient Information Leaflet is given to the patient during the consultation

Outcomes

Primary Outcome Measures

Doctor Patient Communication score
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

Adherence score
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.
Satisfaction score
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.
Doctor Patient Communication score
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.

Full Information

First Posted
September 18, 2014
Last Updated
August 26, 2015
Sponsor
Floralis
Collaborators
Groupe Hospitalier Mutualiste de Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02246361
Brief Title
Impact of Six Patient Information Leaflets (PIL) on Doctor Patient Communication
Acronym
EDIFIP
Official Title
Impact of Six Patient Information Leaflets (PIL) on Doctor Patient Communication and Adherence in Emergency Ward
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Floralis
Collaborators
Groupe Hospitalier Mutualiste de Grenoble

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprain, Infectious Colitis, Diverticulitis, Pyelonephritis, Prostatitis, Pneumonitis
Keywords
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1 (without PIL)
Arm Type
No Intervention
Arm Description
No particular intervention during consultation for the patient
Arm Title
Phase 2
Arm Type
Experimental
Arm Description
Patient Information Leaflet is given to the patient during the consultation
Intervention Type
Procedure
Intervention Name(s)
Patient Information Leaflet (PIL)
Intervention Description
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 Measure Information:
Title
Doctor Patient Communication score
Description
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.
Time Frame
In seven to ten days after delivery
Secondary Outcome Measure Information:
Title
Adherence score
Description
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.
Time Frame
In seven to ten days after the delivery
Title
Satisfaction score
Description
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.
Time Frame
In seven to ten days after the delivery
Title
Doctor Patient Communication score
Description
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.
Time Frame
Just after the visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie Sustersic, MD
Organizational Affiliation
Floralis France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Mutualiste, service des urgences
City
Grenoble
State/Province
Isere
ZIP/Postal Code
38000
Country
France
Facility Name
Centre Hospitalier
City
Chambery
State/Province
Savoie
ZIP/Postal Code
74000
Country
France

12. IPD Sharing Statement

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

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