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

Sponsor
Floralis (Industry)
Overall Status
Completed
CT.gov ID
NCT02246361
Collaborator
Groupe Hospitalier Mutualiste de Grenoble (Other)
211
2
2
8
105.5
13.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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.

Study Design

Study Type:
Interventional
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 :
Sep 1, 2014
Actual Primary Completion Date :
May 1, 2015
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Doctor Patient Communication score [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Groupe Hospitalier Mutualiste, service des urgences Grenoble Isere France 38000
2 Centre Hospitalier Chambery Savoie France 74000

Sponsors and Collaborators

  • Floralis
  • Groupe Hospitalier Mutualiste de Grenoble

Investigators

  • Principal Investigator: Melanie Sustersic, MD, Floralis France

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Floralis
ClinicalTrials.gov Identifier:
NCT02246361
Other Study ID Numbers:
  • N°IRB 5891
First Posted:
Sep 22, 2014
Last Update Posted:
Aug 27, 2015
Last Verified:
Aug 1, 2015

Study Results

No Results Posted as of Aug 27, 2015