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

Gastroenteritis Clinical Trial

— PIL  

Official title:

Impact of Four Patient Information Leaflets (PIL) on Patient Behaviour : a Randomised Controlled Trial in Primary Care.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01398696
• Other study ID #: n° IRB 5891
• Status: Completed
• Phase: Phase 4
• First received: April 19, 2011
• Last updated: October 11, 2011
• Start date: November 2009
• Est. completion date: January 2011

Study information

• Verified date: October 2011
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Commission nationale de l' informatique et des libertés
• Study type: Interventional

Clinical Trial Summary

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

Description:

A patient who visited, for a gastroenteritis or a pharyngitis, one GP of the intervention group, received a Patient Information Leaflets (PIL) related to his disease and his age: either the gastroenteritis leaflet for adult or the one for child, either the pharyngitis leaflet for adult or the one for child.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Gastroenteritis
• Pharyngitis

Intervention

Procedure:
• Patient Information Leaflets
Patient Information Leaflets (PIL) about adult gastroenteritis, children gastroenteritis, adult pharyngitis or either children pharyngitis in consultation room
• usual consultation
No particular intervention during consultation for the Patient. No Information Leaflets (PIL) is given

Locations

Country	Name	City	State
France	General practitioner office	Antibes Juan Les Pins
France	General practitioner office	Beaulieu Sur Mer
France	General practitioner office	Chambery
France	General practitioner office	Charolles
France	General practitioner office	Chirens
France	General practitioner office	Coublevie
France	General practitioner office	Echirolles
France	General practitioner office	Grenoble
France	University Hospital Grenoble	Grenoble
France	General practitioner office	La Buisse
France	General practitioner office	La Murette
France	General practitioner office	Lyon
France	General practitioner office	Massy
France	General practitioner office	Megeve
France	General practitioner office	Plessis Robinson
France	General practitioner office	Saint Etienne de Crossey
France	General practitioner office	Saint Marcellin
France	General practitioner office	Saint Martin D'heres
France	General practitioner office	Saint Priest
France	General practitioner office	Saint Sorlin
France	General practitioner office	Ugine
France	General practitioner office	Valence
France	General practitioner office	Voiron

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (28)

Al-Asfour A, Andersson L. The effect of a leaflet given to parents for first aid measures after tooth avulsion. Dent Traumatol. 2008 Oct;24(5):515-21. doi: 10.1111/j.1600-9657.2008.00651.x. — View Citation

Carré PC, Roche N, Neukirch F, Radeau T, Perez T, Terrioux P, Ostinelli J, Pouchain D, Huchon G. The effect of an information leaflet upon knowledge and awareness of COPD in potential sufferers. A randomized controlled study. Respiration. 2008;76(1):53-60. doi: 10.1159/000115947. Epub 2008 Feb 5. — View Citation

Coudeyre E, Givron P, Vanbiervliet W, Benaïm C, Hérisson C, Pelissier J, Poiraudeau S. [The role of an information booklet or oral information about back pain in reducing disability and fear-avoidance beliefs among patients with subacute and chronic low back pain. A randomized controlled trial in a rehabilitation unit]. Ann Readapt Med Phys. 2006 Nov;49(8):600-8. Epub 2006 May 26. French. — View Citation

Coudeyre E, Poiraudeau S, Revel M, Kahan A, Drapé JL, Ravaud P. Beneficial effects of information leaflets before spinal steroid injection. Joint Bone Spine. 2002 Dec;69(6):597-603. — View Citation

Dedianne MC, Hauzanneau P, Labarere J, Moreau A. Relation médecin-malade en soins primaires: qu'attendent les patients? Investigation par la méthode qualitative des focus groups. La revue du praticien Médecine générale. 2003;17 (612):653-6.

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. — View Citation

Johnson LK, Edelman A, Jensen J. Patient satisfaction and the impact of written material about postpartum contraceptive decisions. Am J Obstet Gynecol. 2003 May;188(5):1202-4. — View Citation

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. Review. — View Citation

Kitching JB. Patient information leaflets--the state of the art. J R Soc Med. 1990 May;83(5):298-300. — View Citation

Leichtnam-Dugarin L, Carretier J, Delavigne V, Brusco S, Hoarau H, Philip T, Fervers B; Comité d'Organisation des Standards, Options et Recommentations SAVOIR; Fédération Nationale des Centres de lutte contre le cancer; Ligue contre le Cancer; Fédération Hospitalière de France; Fédération Nationale de Cancérologie des CHRU; Fédération Française de Cancérologie. [The SOR SAVOIR Patient, a project of patient information and education]. Cancer Radiother. 2003 Jun;7(3):210-2. French. — View Citation

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. — View Citation

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. Epub 2004 Feb 13. — View Citation

Little P, Griffin S, Kelly J, Dickson N, Sadler C. Effect of educational leaflets and questions on knowledge of contraception in women taking the combined contraceptive pill: randomised controlled trial. BMJ. 1998 Jun 27;316(7149):1948-52. — View Citation

Macfarlane J, Holmes W, Gard P, Thornhill D, Macfarlane R, Hubbard R. Reducing antibiotic use for acute bronchitis in primary care: blinded, randomised controlled trial of patient information leaflet. BMJ. 2002 Jan 12;324(7329):91-4. — View Citation

Macfarlane JT, Holmes WF, Macfarlane RM. Reducing reconsultations for acute lower respiratory tract illness with an information leaflet: a randomized controlled study of patients in primary care. Br J Gen Pract. 1997 Nov;47(424):719-22. — View Citation

Mancini J, Noguès C, Adenis C, Berthet P, Bonadona V, Chompret A, Coupier I, Eisinger F, Fricker JP, Gauthier-Villars M, Lasset C, Lortholary A, N'Guyen TD, Vennin P, Sobol H, Stoppa-Lyonnet D, Julian-Reynier C. Impact of an information booklet on satisfaction and decision-making about BRCA genetic testing. Eur J Cancer. 2006 May;42(7):871-81. Epub 2006 Mar 23. — View Citation

McIntosh A, Shaw CF. Barriers to patient information provision in primary care: patients' and general practitioners' experiences and expectations of information for low back pain. Health Expect. 2003 Mar;6(1):19-29. — View Citation

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. — View Citation

Roberts L, Little P, Chapman J, Cantrell T, Pickering R, Langridge J. The back home trial: general practitioner-supported leaflets may change back pain behavior. Spine (Phila Pa 1976). 2002 Sep 1;27(17):1821-8. — View Citation

Roland M, Dixon M. Randomized controlled trial of an educational booklet for patients presenting with back pain in general practice. J R Coll Gen Pract. 1989 Jun;39(323):244-6. — View Citation

Scala D, Cozzolino S, D'Amato G, Cocco G, Sena A, Martucci P, Ferraro E, Mancini AA. Sharing knowledge is the key to success in a patient-physician relationship: how to produce a patient information leaflet on COPD. Monaldi Arch Chest Dis. 2008 Jun;69(2):50-4. — View Citation

Stewart M, Brown JB, Donner A, McWhinney IR, Oates J, Weston WW, Jordan J. The impact of patient-centered care on outcomes. J Fam Pract. 2000 Sep;49(9):796-804. — View Citation

Sustersic M, Meneau A, Drémont 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. — View Citation

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 généra

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.

Vetto JT, Dubois PM, Vetto IP. The impact of distribution of a patient-education pamphlet in a multidisciplinary breast clinic. J Cancer Educ. 1996 Fall;11(3):148-52. — View Citation

Vuorma S, Rissanen P, Aalto AM, Hurskainen R, Kujansuu E, Teperi J. Impact of patient information booklet on treatment decision--a randomized trial among women with heavy menstruation. Health Expect. 2003 Dec;6(4):290-7. — View Citation

Watkins CJ, Papacosta AO, Chinn S, Martin J. A randomized controlled trial of an information booklet for hypertensive patients in general practice. J R Coll Gen Pract. 1987 Dec;37(305):548-50. — View Citation

* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	the mean comprehension score	All patients (or their parent) were called, ten to fifteen days after the visit, to answer a questionnaire on their comprehension related to the disease since they visited the GP. It permitted to calculate a comprehension score. Better was this score, better was the patient's comprehension.	in ten to fifteen days after the visit	No
Secondary	number of visit of patient's family for the same pathology	we get the information by a phone call to the patient, in ten to fifteen days after the visit	in ten to fifteen days after the visit	No