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ISRCTN
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ISRCTN74420611
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ClinicalTrials.gov identifier
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Public title
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Impact of pharmacists ACCESs to clinical information on the quality and the continuity of care in poly-medicamented community patients: a randomised controlled trial
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Scientific title
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Acronym
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ACCES
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Serial number at source
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N/A
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Study hypothesis
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Drug-related problems (DRP) are associated with an increased morbidity and mortality. In the primary care setting, the number of poly-medicamented patients is constantly increasing, resulting in an increased risk of DRP.
Access to clinical information, such as laboratory results and health problems, should help the community pharmacist detect more DRPs. The detection of these DRPs, and better documented pharmacist's suggestions, can result in an increase of the acceptance rate by general practitioners. To our knowledge, there are few studies on the impact of access to clinical information on the detection of DRPs by community pharmacists.
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Ethics approval
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Ethics approval received from the local medical ethics committee (Centre de santé et de services sociaux [CSSS] de Laval Ethics Committee) on the 24th September 2007.
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Study design
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Randomised controlled trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Drug-related problems from multiple prescription drugs
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Participants - inclusion criteria
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Family doctors or residents:
1. Practicing at the Family Medicine Clinic of CSSS de Laval
2. Agree to participate and sign the consent form
Community pharmacists:
1. Practicing in one of the pharmacies in the area of Laval or surrounding areas
2. Have one or more patients eligible for the study
3. Agree to participate and sign the consent form
Patients:
1. 18 years old or older, either sex
2. Have an appointment at the Family Medicine Clinic of CSSS de Laval between October 2007 and March 2008
3. Takes at least five chronic medications
4. Reports being a patient of one of the participating pharmacies
5. Agrees to participate and sign the consent form
6. Is considered eligible by his family doctor
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Participants - exclusion criteria
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1. Is not able to speak or read French
2. Is a patient of more than one community pharmacy
3. Is not able to give a informed consent
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Anticipated start date
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01/10/2007
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Anticipated end date
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24/04/2008
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Status of trial
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Completed
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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170
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Interventions
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All pharmacists in the area of Laval were invited to a three-hour workshop on the interpretation of laboratory results. They also have access to a consultation service with pharmacists currently working at the Family Medicine Clinic of CSSS de Laval. For all patients, the family doctor asked the community pharmacist to perform an analysis of the pharmacotherapy.
To help the pharmacist analyse the drug profile, the intervention group received the following clinical information:
1. Most recent laboratory results:
1.1. Creatinine clearance
1.2. Potassium
1.3. Sodium
1.4. Lipid profile
1.5. Alanine aminotransferase (ALT)
1.6. Creatine kinase (CK)
1.7. Glycosylated haemoglobin (HbA1c)
1.8. Thyroid stimulating hormone (TSH) and free thyroxine (FT4)
1.9. Complete blood count
1.10. Blood levels of certain drugs (phenytoin, digoxin, lithium)
2. Health problems
3. Drug profile as figured in the medical record
The control group received usual care.
The duration of follow-up was 8 weeks in both groups.
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Primary outcome measure(s)
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The following will be assessed after two months of follow-up:
1. Compare the mean number of DRP per patient identified by community pharmacists in both groups (intervention group and control group)
2. Compare the mean number of pharmacotherapy changes per patient between both groups (intervention group and control group)
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Secondary outcome measure(s)
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The following will be assessed after two months of follow-up:
1. Compare the proportion of patients in each group for whom at least one intervention was made by the community pharmacists
2. For each type of intervention, compare the proportion of interventions made by the community pharmacists in both groups
3. Compare the proportion of pharmaceutical opinions that resulted in a pharmacotherapy change in both groups
4. Describe and compare the type of contact made between community pharmacists and Family Medicine Clinic’s pharmacists in both groups
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Sources of funding
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Pfizer (Canada)
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Trial website
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Publications
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Contact name
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Dr
Lyne
Lalonde
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Address
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Resaerch Team in Primary Care
CSSS de Laval, Hôpital de la Cité-de-la-Santé
1755 René-Laennec, room D-S145
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City/town
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Laval
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Zip/Postcode
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H7M 3L9
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Country
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Canada
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Tel
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+1 450 668 1010 ext. 2743
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Fax
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+1 450 975 5089
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Email
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lyne.lalonde@umontreal.ca
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Sponsor
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Pfizer (Canada)
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Address
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c/o Chideh Motallebi, PhD, MBA
Spécialiste régional médical et de la recherche Cardiovasculaire - QC
Pfizer Canada Inc. Division Médicale
17300, autoroute Transcanadienne
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City/town
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Kirkland
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Zip/Postcode
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H9J 2M5
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Country
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Canada
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Tel
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+1 450 466 3952
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Fax
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+1 450 466 8568
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Email
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Chideh.Motallebi@Pfizer.com
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Sponsor website:
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http://www.pfizer.ca
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Date applied
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16/04/2008
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Last edited
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18/06/2008
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Date ISRCTN assigned
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18/06/2008
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