Contact information
Type
Scientific
Primary contact
Dr Lyne Lalonde
ORCID ID
Contact details
Resaerch Team in Primary Care
CSSS de Laval
Hôpital de la Cité-de-la-Santé
1755 René-Laennec
room D-S145
Laval
H7M 3L9
Canada
+1 450 668 1010 ext. 2743
lyne.lalonde@umontreal.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
ACCES
Study hypothesis
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.
Ethics approval
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.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Drug-related problems from multiple prescription drugs
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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)
Secondary outcome measures
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 Clinics pharmacists in both groups
Overall trial start date
01/10/2007
Overall trial end date
24/04/2008
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
170
Participant exclusion criteria
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
Recruitment start date
01/10/2007
Recruitment end date
24/04/2008
Locations
Countries of recruitment
Canada
Trial participating centre
Resaerch Team in Primary Care
Laval
H7M 3L9
Canada
Sponsor information
Organisation
Pfizer (Canada)
Sponsor details
c/o Chideh Motallebi
PhD
MBA
Spécialiste régional médical et de la recherche Cardiovasculaire - QC
Pfizer Canada Inc. Division Médicale
17300
autoroute Transcanadienne
Kirkland
H9J 2M5
Canada
+1 450 466 3952
Chideh.Motallebi@Pfizer.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Pfizer (Canada)
Alternative name(s)
Pfizer Inc.
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary