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Trial registered on ANZCTR


Registration number
ACTRN12610000613000
Ethics application status
Approved
Date submitted
17/06/2010
Date registered
28/07/2010
Date last updated
28/07/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of a training and communication-network nephrology program for community pharmacists
Scientific title
Development and impact of PROFIL ("Programme de Formation et de Liaison"), a training and communication network program for community pharmacists, on the clinical follow-up of moderate to severe chronic renal insufficiency patients: a cluster randomized controlled trial
Secondary ID [1] 252291 0
CRG090600086 (Cochrane Renal Group registry)
Universal Trial Number (UTN)
Trial acronym
PROFIL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic kidney disease 256720 0
Condition category
Condition code
Renal and Urogenital 256879 256879 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ProFiL (Programme de Formation et de Liaison) is a training and communication-network program designed to facilitate pharmaceutical care by community pharmacists. It comprises: 1) a training workshop; 2) a communication network to facilitate transfer of clinical information between a predialysis clinic and community pharmacies; and 3) a consultation service by hospital pharmacists with nephrology expertise.

Between September and November 2004, all Laval (Canada) community pharmacies were asked to participate and randomly assigned to the ProFiL or usual-care (UC) group. ProFiL pharmacists attended a training workshop in November or December 2004. Patients of participating pharmacies attending a predialysis clinic were recruited between January and May 2005 and evaluated at baseline and six months.

A three-hour workshop was developed by pharmacists and nephrologists. The objectives were to: 1) update basic knowledge on drug therapy in CKD to facilitate detection, prevention and management of DRPs; 2) familiarize pharmacists with ProFiL; 3) review administrative rules governing pharmaceutical opinions; and 4) meet the predialysis health care professionals. The workshop was offered on three occasions in November 2004 and December 2004. Pharmacists received 5.4 continuing education credits from the Quebec Order of Pharmacists. By the end of the workshop, it was expected that pharmacists would be able to: 1) identify nephrotoxic medications and propose alternatives to avoid their use; 2) adjust medication dosage in CKD; 3) write a pharmaceutical opinion; and 4) provide counselling on over-the-counter medications. The workshop included lecture presentations on: 1) clinical presentation of CKD (15 minutes) by a nephrologist; 2) management of DRPs in CKD (15 minutes) by a hospital pharmacist with expertise in nephrology; 3) writing of pharmaceutical opinions (15 minutes) by a community pharmacist; and 4) presentation of the ProFiL clinical tools (10 minutes by a pharmacist, including medication dosage adjustment tables for prescribed medications, over-the-counter medications and natural products. Two case studies (60 minutes) on the management of moderate and severe CKD were discussed in group of three or four pharmacists and within the entire group. Pharmacists had to use the information provided on the ProFiL clinical tools to identify DRPs and write a pharmaceutical opinion. If needed pharmacists responsible for the consultation service were available to answer questions.
Intervention code [1] 255947 0
Other interventions
Comparator / control treatment
Usual care community pharmacists (control group) did not have access to the ProFiL program.
Control group
Active

Outcomes
Primary outcome [1] 240877 0
Mean number of pharmacist interventions (refusals and pharmaceutical opinions) per patient (community pharmacy prescribing renewal charts)
Timepoint [1] 240877 0
For the 6 months prior to baseline, and from the baseline to 6 months during the study period
Secondary outcome [1] 257547 0
Proportion of the different types of refusals and pharmaceutical opinions issued (community pharmacy prescribing renewal charts)
Timepoint [1] 257547 0
For the 6 months prior to baseline, and from the baseline to 6 months during the study period
Secondary outcome [2] 263127 0
Mean changes in the clinical variables (predialysis medical charts)
Timepoint [2] 263127 0
At baseline (at patient enrolment), and 6 months
Secondary outcome [3] 263128 0
Mean number of telephone contacts per patient between the community pharmacists and the consultation service offered by the pre-dialysis clinic's pharmacists (pharmacist's diary)
Timepoint [3] 263128 0
During the 6 month study period
Secondary outcome [4] 263129 0
Patient satisfaction with community pharmaceutical services (self-administered questionnaire)
Timepoint [4] 263129 0
After the 6 month study period
Secondary outcome [5] 263130 0
Community pharmacists' satisfaction with the PROFIL program (self-administered questionnaire)
Timepoint [5] 263130 0
Once all their study patients had completed the study
Secondary outcome [6] 263131 0
Change in knowledge about the pharmacological treatment of chronic kidney disease and pharmaceutical opinions and refusals in the PROFIL group pharmacists (self-administered questionnaire)
Timepoint [6] 263131 0
Before and immediately after the training
Secondary outcome [7] 263132 0
Direct cost of the PROFIL program to the community pharmacist obtained from 1) pharmacy medication renewal charts; 2) liaison pharmacist diary; 3) self-administered questionnaire from community pharmacist
Timepoint [7] 263132 0
During the 6 month study period

Eligibility
Key inclusion criteria
1) The patient is a regular customer at one of the participating community pharmacies;
2) Is attending the study pre-dialysis clinic;
3) Is at least 18 years of age;
4) Is covered by the Regie de l'assurance maladie du Quebec (RAMQ) with regard to his/her drugs for the entire duration of the study (employment insurance recipient, person aged 65 or older or member) and at least six months prior to study entry;
5) Agrees to use his/her usual community pharmacy for the entire duration of the study (six months);
6) Speaks and reads French;
7) Agrees to participate in the study and has signed the consent form.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Unable to speak and read French andEnglish;
2) Unable to follow the study requirement

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Chronic kidney disease patients attending a predyalisis clinics and patients of one of the participating community pharmacies were sollicited. Joelle Brossard, a research officer on the Primary Care Research Team, will be responsible for generating the randomization lists and preparing the envelopes containing the study group assignment instructions. Together with the Director of Research (Lyne Lalonde), she will determine the pharmacy group size. Thus, the members of the care team and the project's research officer will be blinded to the size of the groups. Each envelope will be identified by a number. The numbers will be assigned in sequential order, from the smallest to the largest.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once all the pharmacists at a given community pharmacy have been invited to participate in the study, the pharmacy will be randomized to one of the two study groups: the PROFIL group or usual care (UC) group. Each pharmacy will have a 50% chance of being assigned to the UC group and a 50% chance of being assigned to the PROFIL program. The randomization will be stratified according to the number of prescriptions per hour per pharmacist: less than or equal to 25 prescriptions per hour per pharmacist and more than 25 prescriptions per hour per pharmacist. For each stratum, the randomization will be performed with a group of "x" pharmacies. Joelle Brossard, a research officer on the Primary Care Research Team, will be responsible for generating the randomization lists using computerised sequence generation, and preparing the envelopes containing the study group assignment instructions. Together with the Director of Research (Lyne Lalonde), she will determine the pharmacy group size. Thus, the members of the care team and the project's research officer will be blinded to the size of the groups. Each envelope will be identified by a number. The numbers will be assigned in sequential order, from the smallest to the largest.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Cluster randomized trial. A cluster was defined as a community pharmacy and its participating pharmacists and patients.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 2129 0
Canada
State/province [1] 2129 0

Funding & Sponsors
Funding source category [1] 256444 0
University
Name [1] 256444 0
Cercle du doyen
Country [1] 256444 0
Canada
Funding source category [2] 257127 0
Commercial sector/Industry
Name [2] 257127 0
Pharmaceutical Partners of Canada
Country [2] 257127 0
Canada
Primary sponsor type
Commercial sector/Industry
Name
Pfizer Canada
Address
17300 Trans-Canada Highway
Kirkland, Quebec, H9J 2M5
Country
Canada
Secondary sponsor category [1] 255744 0
Commercial sector/Industry
Name [1] 255744 0
Merck Frosst Canada
Address [1] 255744 0
16711 Trans-Canada Highway
Kirkland, Quebec, H9H 3L1
Country [1] 255744 0
Canada
Other collaborator category [1] 1096 0
Commercial sector/Industry
Name [1] 1096 0
Amgen Canada
Address [1] 1096 0
6775 Financial Drive, bureau 100
Mississauga, Ontario, L5N 0A4
Country [1] 1096 0
Canada
Other collaborator category [2] 1097 0
Commercial sector/Industry
Name [2] 1097 0
Bristol Myers Squibb-Sanofi
Address [2] 1097 0
2344 Alfred-Nobel Blvd, bureau 300
Montreal, Quebec, H4S 0A4
Country [2] 1097 0
Canada
Other collaborator category [3] 1098 0
Commercial sector/Industry
Name [3] 1098 0
ProDoc
Address [3] 1098 0
2925 Industriel Blvd.
Laval, Quebec, H7L 3W9
Country [3] 1098 0
Canada
Other collaborator category [4] 1099 0
Commercial sector/Industry
Name [4] 1099 0
Leo Pharma
Address [4] 1099 0
123 Commerce Valley Drive E., Suite 400
Thornhill, Ontario, L3T 7W8
Country [4] 1099 0
Canada
Other collaborator category [5] 1100 0
Commercial sector/Industry
Name [5] 1100 0
Sabex
Address [5] 1100 0
145 Jules-Leger
Boucherville, Quebec, J4B 7K8
Country [5] 1100 0
Canada
Other collaborator category [6] 1101 0
Commercial sector/Industry
Name [6] 1101 0
Roche
Address [6] 1101 0
2455 Meadowpine Blvd.
Mississauga, Ontario, L5N 6L7
Country [6] 1101 0
Canada
Other collaborator category [7] 1102 0
Commercial sector/Industry
Name [7] 1102 0
Shire Biochem
Address [7] 1102 0
275 Armand-Frappier
Laval, Quebec, H7V 4A7
Country [7] 1102 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259180 0
Scientific and Research Ethics Committee
Ethics committee address [1] 259180 0
Ethics committee country [1] 259180 0
Canada
Date submitted for ethics approval [1] 259180 0
Approval date [1] 259180 0
15/06/2004
Ethics approval number [1] 259180 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30262 0
Address 30262 0
Country 30262 0
Phone 30262 0
Fax 30262 0
Email 30262 0
Contact person for public queries
Name 13509 0
Dr, Lyne, Lalonde
Address 13509 0
Associate professor; Sanofi aventis Endowment Research Chair in ambulatory pharmaceutical care; Research team in primary care of the Centre de sante et de services sociaux de Laval; Faculty of Pharmacy, University of Montreal, Universite de Montreal, Pavillon Jean-Coutu, 2940 chemin de Polytechnique, bureau 2238, Montreal (Quebec), H3T 1J4
Country 13509 0
Canada
Phone 13509 0
+1-514-343-6111 ext. 5315
Fax 13509 0
Email 13509 0
lyne.lalonde@umontreal.ca
Contact person for scientific queries
Name 4437 0
Dr, Lyne, Lalonde
Address 4437 0
Associate professor; Sanofi aventis Endowment Research Chair in ambulatory pharmaceutical care; Research team in primary care of the Centre de sante et de services sociaux de Laval; Faculty of Pharmacy, University of Montreal, Universite de Montreal, Pavillon Jean-Coutu, 2940 chemin de Polytechnique, bureau 2238, Montreal (Quebec), H3T 1J4
Country 4437 0
Canada
Phone 4437 0
+1-514-343-6 111 ext. 5315
Fax 4437 0
Email 4437 0
lyne.lalonde@umontreal.ca

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