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Ankle SprainPhase 4EDIFIPNCT02246361

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

A Phase 4 study testing Patient Information Leaflet (PIL) in people with Ankle Sprain and Infectious Colitis, run by Floralis at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Ankle Sprain, Infectious Colitis, Diverticulitis
What is being tested?
Patient Information Leaflet (PIL)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
211 participants
Where
2 sitesFrance
Study dates
Sep 2014to May 2015
Phase
Phase 4
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 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Centre Hospitalier

    Chambéry, Savoie, 74000

  • Groupe Hospitalier Mutualiste, service des urgences

    Grenoble, Isere, 38000

Other trials in France

About this study

Official title: Impact of Six Patient Information Leaflets (PIL) on Doctor Patient Communication and Adherence in Emergency Ward

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.

Read the 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.

Being tested
Patient Information Leaflet (PIL)
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
Medical subject headings
Ankle Injuries, Diverticulitis, Pyelonephritis, Prostatitis, Pneumonia, Personal Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient Information Leaflet (PIL)Procedure or surgery

    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

Study groups in NCT02246361
Study groupRoleWhat they receive
Phase 1 (without PIL)No interventionNo particular intervention during consultation for the patient
Phase 2ExperimentalPatient Information Leaflet is given to the patient during the consultation
Receives: Procedure: Patient Information Leaflet (PIL)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: In seven to ten days after delivery

Secondary outcomes (3)

  1. 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.

    Measured: In seven to ten days after the delivery

  2. 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.

    Measured: In seven to ten days after the delivery

  3. 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.

    Measured: Just after the visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

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 4
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
211 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02246361
Sponsor's protocol ID
N°IRB 5891
Acronym
EDIFIP
Status last verified
Aug 2015
First submitted
18 Sep 2014
Last updated
27 Aug 2015
Results posted
No
Data monitoring committee
No

Publications

  • Sustersic M, Jeannet E, Cozon-Rein L, Marechaux F, Genty C, Foote A, David-Tchouda S, Martinez L, Bosson JL. Impact of information leaflets on behavior of patients with gastroenteritis or tonsillitis: a cluster randomized trial in French primary care. J Gen Intern Med. 2013 Jan;28(1):25-31. doi: 10.1007/s11606-012-2164-8. Epub 2012 Jul 25.

    PubMed 22829293

  • Sustersic M, Meneau A, Dremont R, Paris A, Laborde L, Bosson JL. [Developing patient information sheets in general practice. Proposal for a methodology]. Rev Prat. 2008 Dec 15;58(19 Suppl):17-24. French.

    PubMed 19253787

  • Little P, Moore M, Kelly J, Williamson I, Leydon G, McDermott L, Mullee M, Stuart B; PIPS Investigators. Delayed antibiotic prescribing strategies for respiratory tract infections in primary care: pragmatic, factorial, randomised controlled trial. BMJ. 2014 Mar 6;348:g1606. doi: 10.1136/bmj.g1606.

    PubMed 24603565

  • Coudeyre E, Tubach F, Rannou F, Baron G, Coriat F, Brin S, Revel M, Poiraudeau S. Effect of a simple information booklet on pain persistence after an acute episode of low back pain: a non-randomized trial in a primary care setting. PLoS One. 2007 Aug 8;2(8):e706. doi: 10.1371/journal.pone.0000706.

    PubMed 17684553

  • Grime J, Blenkinsopp A, Raynor DK, Pollock K, Knapp P. The role and value of written information for patients about individual medicines: a systematic review. Health Expect. 2007 Sep;10(3):286-98. doi: 10.1111/j.1369-7625.2007.00454.x.

    PubMed 17678517

  • Gauchet A, Tarquinio C, Fischer G. Psychosocial predictors of medication adherence among persons living with HIV. Int J Behav Med. 2007;14(3):141-50. doi: 10.1007/BF03000185.

    PubMed 18062057

  • Nicolson D, Knapp P, Raynor DK, Spoor P. Written information about individual medicines for consumers. Cochrane Database Syst Rev. 2009 Apr 15;2009(2):CD002104. doi: 10.1002/14651858.CD002104.pub3.

    PubMed 19370575

  • Fox R. Informed choice in screening programmes: do leaflets help? A critical literature review. J Public Health (Oxf). 2006 Dec;28(4):309-17. doi: 10.1093/pubmed/fdl066. Epub 2006 Oct 23.

    PubMed 17060352

  • Graham W, Smith P, Kamal A, Fitzmaurice A, Smith N, Hamilton N. Randomised controlled trial comparing effectiveness of touch screen system with leaflet for providing women with information on prenatal tests. BMJ. 2000 Jan 15;320(7228):155-60. doi: 10.1136/bmj.320.7228.155.

    PubMed 10634736

  • Kenny T, Wilson RG, Purves IN, Clark J Sr, Newton LD, Newton DP, Moseley DV. A PIL for every ill? Patient information leaflets (PILs): a review of past, present and future use. Fam Pract. 1998 Oct;15(5):471-9. doi: 10.1093/fampra/15.5.471.

    PubMed 9848435

  • Little P, Dorward M, Warner G, Moore M, Stephens K, Senior J, Kendrick T. Randomised controlled trial of effect of leaflets to empower patients in consultations in primary care. BMJ. 2004 Feb 21;328(7437):441. doi: 10.1136/bmj.37999.716157.44. Epub 2004 Feb 13.

    PubMed 14966078

  • Raynor DK, Blenkinsopp A, Knapp P, Grime J, Nicolson DJ, Pollock K, Dorer G, Gilbody S, Dickinson D, Maule AJ, Spoor P. A systematic review of quantitative and qualitative research on the role and effectiveness of written information available to patients about individual medicines. Health Technol Assess. 2007 Feb;11(5):iii, 1-160. doi: 10.3310/hta11050.

    PubMed 17280623

  • Paris A, Cornu C, Auquier P, Maison P, Radauceanu A, Brandt C, Salvat-Melis M, Hommel M, Cracowski JL. French adaptation and preliminary validation of a questionnaire to evaluate understanding of informed consent documents in phase I biomedical research. Fundam Clin Pharmacol. 2006 Feb;20(1):97-104. doi: 10.1111/j.1472-8206.2005.00391.x.

    PubMed 16448400

  • Zapata LB, Steenland MW, Brahmi D, Marchbanks PA, Curtis KM. Patient understanding of oral contraceptive pill instructions related to missed pills: a systematic review. Contraception. 2013 May;87(5):674-84. doi: 10.1016/j.contraception.2012.08.026. Epub 2012 Oct 4.

    PubMed 23040136

  • Ziegler A, Hadlak A, Mehlbeer S, Konig IR. Comprehension of the description of side effects in drug information leaflets: a survey of doctors, pharmacists and lawyers. Dtsch Arztebl Int. 2013 Oct;110(40):669-73. doi: 10.3238/arztebl.2013.0669. Epub 2013 Oct 4.

    PubMed 24167524

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Patient Information Leaflet (PIL) in people with Ankle Sprain and Infectious Colitis, run by Floralis at 2 sites 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 3 inclusion and 6 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 27 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Doctor Patient Communication score (time frame: In seven to ten days after delivery). 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 NCT02246361, which also lists 35 linked publications.

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 27 Aug 2015; AzTrials last refreshed its copy on 26 Oct 2026.

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