Impact of Four Patient Information Leaflets (PIL) on Patient Behaviour

NCT01398696 | Completed Phase 4

• 1 other identifier: n° IRB 5891
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 23

Brief Summary

To assess the impact of four Patient Information Leaflets (PIL) on patient behaviour in primary care.

Conditions

Gastroenteritis; Pharyngitis

Keywords

Patient Information Leaflets; primary care; patient behaviour; pharyngitis; gastroenteritis

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure was the mean behaviour score

  All patients were called, ten to fifteen days after the visit, to answer a questionnaire on their behaviour related to the disease since they visited the GP. It permitted to calculate a behaviour score. Better was the score, better was the patient's behaviour related to his disease.

  In ten to fifteen days after patient after the visit

Secondary Outcomes (2)

• the mean comprehension score

  in ten to fifteen days after the visit

• number of visit of patient's family for the same pathology

  in ten to fifteen days after the visit

Study Arms (2)

Patient Information Leaflets

ACTIVE COMPARATOR

Patient Information Leaflets (PIL) is given to the patient during consultation

Procedure: Patient Information Leaflets

usual consultation without PIL

PLACEBO COMPARATOR

no particular intervention during consultation for the patient.

Procedure: usual consultation

Interventions

Patient Information Leaflets PROCEDURE

Patient Information Leaflets (PIL) about adult gastroenteritis, children gastroenteritis, adult pharyngitis or either children pharyngitis in consultation room

Patient Information Leaflets

usual consultation PROCEDURE

No particular intervention during consultation for the Patient. No Information Leaflets (PIL) is given

usual consultation without PIL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient.
• Minor child accompanied by a responsible adult.
• The patient or the caregiver must be reachable by telephone within ten to fifteen days following the consultation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (23)

General practitioner office

Beaulieu-sur-Mer, France

Location

General practitioner office

Chambéry, France

Location

General practitioner office

Charolles, France

Location

General practitioner office

Chirens, France

Location

General practitioner office

Coublevie, France

Location

General practitioner office

Échirolles, France

Location

General practitioner office

Grenoble, 38000, France

Location

University Hospital Grenoble

Grenoble, France

Location

General practitioner office

Juan-les-Pins, France

Location

General practitioner office

La Buisse, France

Location

General practitioner office

La Murette, France

Location

General practitioner office

Le Plessis-Robinson, France

Location

General practitioner office

Lyon, France

Location

General practitioner office

Massy, France

Location

General practitioner office

Megève, France

Location

General practitioner office

Saint-Étienne-de-Crossey, France

Location

General practitioner office

Saint-Marcellin, France

Location

General practitioner office

Saint-Martin-d'Hères, France

Location

General practitioner office

Saint-Priest, France

Location

General practitioner office

Saint-Sorlin, France

Location

General practitioner office

Ugine, France

Location

General practitioner office

Valence, France

Location

General practitioner office

Voiron, France

Location

Related Publications (29)

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• Leichtnam-Dugarin L, Carretier J, Delavigne V, Brusco S, Hoarau H, Philip T, Fervers B; Comite d'Organisation des Standards, Options et Recommentations SAVOIR; Federation Nationale des Centres de lutte contre le cancer; Ligue contre le Cancer; Federation Hospitaliere de France; Federation Nationale de Cancerologie des CHRU; Federation Francaise de Cancerologie. [The SOR SAVOIR Patient, a project of patient information and education]. Cancer Radiother. 2003 Jun;7(3):210-2. doi: 10.1016/s1278-3218(03)00037-4. No abstract available. French.

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  BACKGROUND

• Paul F, Jones MC, Hendry C, Adair PM. The quality of written information for parents regarding the management of a febrile convulsion: a randomized controlled trial. J Clin Nurs. 2007 Dec;16(12):2308-22. doi: 10.1111/j.1365-2702.2007.02019.x.

  PMID: 18036121 BACKGROUND

• Sustersic M, Voorhoeve M, Menuret H, Baudrant M, Meneau A, Bosson JL. Fiches d'information pour les patients: quel intérêt? L'étude EDIMAP. La Revue de la médecine générale. 2010;276:332-9.

  BACKGROUND

• Francis NA, Butler CC, Hood K, Simpson S, Wood F, Nuttall J. Effect of using an interactive booklet about childhood respiratory tract infections in primary care consultations on reconsulting and antibiotic prescribing: a cluster randomised controlled trial. BMJ. 2009 Jul 29;339:b2885. doi: 10.1136/bmj.b2885.

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• Lerman C, Ross E, Boyce A, Gorchov PM, McLaughlin R, Rimer B, Engstrom P. The impact of mailing psychoeducational materials to women with abnormal mammograms. Am J Public Health. 1992 May;82(5):729-30. doi: 10.2105/ajph.82.5.729.

  PMID: 1566953 BACKGROUND

• 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.

  PMID: 19253787 RESULT

• Sustersic M, Meneau A, Dremont R, Bosson JL. Fiches d'information patient: quelle méthodologie? La revue du praticien Médecine générale. 2007;790:1167-8.

  RESULT

• Sustersic M, Meneau A, Drémont R, Paris A, Laborde L, Bosson JL. Elaboration d'un outil d'aide à l'éducation du patient pas la réalisation de 125 fiches d'information et de conseil concernant des motifs de consultation les plus fréquents en médecin générale. Université Joseph Fourier, faculté de médecine de Grenoble. juillet 2007.

  RESULT

MeSH Terms

Conditions

Gastroenteritis; Pharyngitis

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Melanie Sustersic, GP

  University Hospital, Grenoble

  STUDY DIRECTOR

• Jean-Luc Bosson, PHD

  University Hospital, Grenoble

  STUDY DIRECTOR

• LUCILE REIN, MD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

• EVA JEANNET, MD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2011
• First Posted: July 20, 2011
• Study Start: November 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: October 12, 2011

Record last verified: 2011-10

Locations

FR (23)