GastroenteritisPhase 4PILNCT01398696
Impact of Four Patient Information Leaflets (PIL) on Patient Behaviour
A Phase 4 study testing Patient Information Leaflets and usual consultation in people with Gastroenteritis and Pharyngitis, run by University Hospital, Grenoble at 23 sites in France.
Trial summary
To assess the impact of four Patient Information Leaflets (PIL) on patient behaviour in primary care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastroenteritis, Pharyngitis
- What is being tested?
- Patient Information Leaflets and usual consultation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 23 sitesFrance
- Study dates
- Nov 2009to Jan 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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
23 sites in 1 country.
23 sites in 1 country
France23 sites
General practitioner office
Beaulieu-sur-Mer
General practitioner office
Chambéry
General practitioner office
Charolles
General practitioner office
Chirens
General practitioner office
Coublevie
General practitioner office
Échirolles
General practitioner office
Grenoble, 38000
University Hospital Grenoble
Grenoble
General practitioner office
Juan-les-Pins
General practitioner office
La Buisse
General practitioner office
La Murette
General practitioner office
Le Plessis-Robinson
General practitioner office
Lyon
General practitioner office
Massy
General practitioner office
Megève
General practitioner office
Saint-Étienne-de-Crossey
General practitioner office
Saint-Marcellin
General practitioner office
Saint-Martin-d'Hères
General practitioner office
Saint-Priest
General practitioner office
Saint-Sorlin
General practitioner office
Ugine
General practitioner office
Valence
General practitioner office
Voiron
About this study
Official title: Impact of Four Patient Information Leaflets (PIL) on Patient Behaviour : a Randomised Controlled Trial in Primary Care.
To assess the impact of four Patient Information Leaflets (PIL) on patient behaviour in primary care.
Read the detailed 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.
- Conditions
- Gastroenteritis, Pharyngitis
- Being tested
- Patient Information Leaflets, usual consultation
- Keywords
- Patient Information Leaflets, primary care, patient behaviour, pharyngitis, gastroenteritis
- Medical subject headings
- Gastroenteritis, Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Information LeafletsProcedure or surgery
Patient Information Leaflets (PIL) about adult gastroenteritis, children gastroenteritis, adult pharyngitis or either children pharyngitis in consultation room
usual consultationProcedure or surgery
No particular intervention during consultation for the Patient. No Information Leaflets (PIL) is given
| Study group | Role | What they receive |
|---|---|---|
| Patient Information Leaflets | Active comparator | Patient Information Leaflets (PIL) is given to the patient during consultation Receives: Procedure: Patient Information Leaflets |
| usual consultation without PIL | Placebo comparator | no particular intervention during consultation for the patient. Receives: Procedure: usual consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: In ten to fifteen days after patient after the visit
Secondary outcomes (2)
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.
Measured: in ten to fifteen days after the visit
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
Measured: in ten to fifteen days after the visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startNov 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for GastroenteritisStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melanie Sustersic, GP, Study director, University Hospital, GrenobleJean-Luc Bosson, PHD, Study director, University Hospital, GrenobleLUCILE REIN, MD, Principal investigator, University Hospital, GrenobleEVA JEANNET, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398696
- Sponsor's protocol ID
- n° IRB 5891
- Acronym
- PIL
- Status last verified
- Oct 2011
- First submitted
- 19 Apr 2011
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11032203Kitching JB. Patient information leaflets--the state of the art. J R Soc Med. 1990 May;83(5):298-300. doi: 10.1177/014107689008300506. No abstract available.
PubMed 2380944Kenny 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 9848435Little 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. doi: 10.1136/bmj.316.7149.1948.
PubMed 9641933Little 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 14966078Coudeyre E, Givron P, Vanbiervliet W, Benaim C, Herisson 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. doi: 10.1016/j.annrmp.2006.05.003. Epub 2006 May 26. French.
PubMed 16793163Coudeyre E, Poiraudeau S, Revel M, Kahan A, Drape JL, Ravaud P. Beneficial effects of information leaflets before spinal steroid injection. Joint Bone Spine. 2002 Dec;69(6):597-603. doi: 10.1016/s1297-319x(02)00457-8.
PubMed 12537268McIntosh 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. doi: 10.1046/j.1369-6513.2003.00197.x.
PubMed 12603625Watkins 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.
PubMed 3503941Roberts 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. doi: 10.1097/00007632-200209010-00002.
PubMed 12221342Johnson 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. doi: 10.1067/mob.2003.308.
PubMed 12748478Mancini J, Nogues 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. doi: 10.1016/j.ejca.2005.10.029. Epub 2006 Mar 23.
PubMed 16563745Al-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.
PubMed 18821954Carre 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.
PubMed 18253024Scala 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. doi: 10.4081/monaldi.2008.395.
PubMed 18837416
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Four Patient Information Leaflets (PIL) on Patient Behaviour : a Randomised Controlled Trial in Primary Care.
- ClinicalTrials.gov ID
- NCT01398696
- Acronym / sponsor ID
- PIL / n° IRB 5891
- Conditions
- Gastroenteritis, Pharyngitis
- Keywords
- Patient Information Leaflets, primary care, patient behaviour, pharyngitis, gastroenteritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 20 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the impact of four Patient Information Leaflets (PIL) on patient behaviour in primary care.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Information Leaflets | Active comparator | Procedure: Patient Information LeafletsPatient Information Leaflets (PIL) is given to the patient during consultation |
| usual consultation without PIL | Placebo comparator | Procedure: usual consultationno particular intervention during consultation for the patient. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Illiterate patient
- Patient refusing follow-up call.
- Patient with visual or hearing impairment.
- Patient non-Francophone.
- Private patient of liberty by judicial or administrative.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Information LeafletsPatient Information Leaflets (PIL) about adult gastroenteritis, children gastroenteritis, adult pharyngitis or either children pharyngitis in consultation room | Procedure or surgery | Patient Information Leaflets |
| usual consultationNo particular intervention during consultation for the Patient. No Information Leaflets (PIL) is given | Procedure or surgery | usual consultation without PIL |
Primary outcome
The primary outcome measure was the mean behaviour score
Time frame: In ten to fifteen days after patient after the visit
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.
2 secondary outcomes
the mean comprehension score
Time frame: in ten to fifteen days after the visit
number of visit of patient's family for the same pathology
Time frame: in ten to fifteen days after the visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2011.
- Background: PubMed 11032203Stewart 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.
- Background: PubMed 2380944Kitching JB. Patient information leaflets--the state of the art. J R Soc Med. 1990 May;83(5):298-300. doi: 10.1177/014107689008300506. No abstract available.
- Background: PubMed 9848435Kenny 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.
- Background: PubMed 9641933Little 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. doi: 10.1136/bmj.316.7149.1948.
- Background: PubMed 14966078Little 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.
- Background: PubMed 16793163Coudeyre E, Givron P, Vanbiervliet W, Benaim C, Herisson 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. doi: 10.1016/j.annrmp.2006.05.003. Epub 2006 May 26. French.
- Background: PubMed 12537268Coudeyre E, Poiraudeau S, Revel M, Kahan A, Drape JL, Ravaud P. Beneficial effects of information leaflets before spinal steroid injection. Joint Bone Spine. 2002 Dec;69(6):597-603. doi: 10.1016/s1297-319x(02)00457-8.
- Background: PubMed 12603625McIntosh 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. doi: 10.1046/j.1369-6513.2003.00197.x.
- Background: PubMed 3503941Watkins 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.
- Background: PubMed 12221342Roberts 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. doi: 10.1097/00007632-200209010-00002.
- Background: PubMed 12748478Johnson 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. doi: 10.1067/mob.2003.308.
- Background: PubMed 16563745Mancini J, Nogues 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. doi: 10.1016/j.ejca.2005.10.029. Epub 2006 Mar 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie Sustersic, GP study director
University Hospital, Grenoble
Jean-Luc Bosson, PHD study director
University Hospital, Grenoble
LUCILE REIN, MD principal investigator
University Hospital, Grenoble
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Patient Information Leaflets and usual consultation in people with Gastroenteritis and Pharyngitis, run by University Hospital, Grenoble at 23 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 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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. Some participants in this study may receive a placebo. 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?
The primary outcome measure was the mean behaviour score (time frame: In ten to fifteen days after patient after the visit). 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 NCT01398696, which also lists 28 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 12 Oct 2011.