Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001088033
Ethics application status
Approved
Date submitted
7/12/2010
Date registered
13/12/2010
Date last updated
8/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the impact of a training-and-communication network program in nephrology to facilitate the detection and management of drug-related problems by community pharmacists.
Scientific title
Evaluating the impact of a training-and-communication network program (ProFiL : "Programme de Formation et de Liaison" ) in nephrology to facilitate the detection and management of drug-related problems by community pharmacists: A multicenter cluster randomized controlled trial
Secondary ID [1] 253271 0
There is no secondary IDs
Universal Trial Number (UTN)
Trial acronym
ProFiL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic kidney disease 258798 0
Condition category
Condition code
Renal and Urogenital 258663 258663 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For the studied year, the intervention will includes: 1) a Web-based interactive training program for community pharmacists on the prevention, detection and management of highly relevant DRPs in CKD patients, as defined by the PAIR criteria, as well as a Web-discussion forum once at the start of the study; 2) a communication-network program to facilitate the transfer of clinical information between the predialysis clinic and community pharmacists, when needed by the pharmacist during the stydied year; and 3) a seamless-care service offered to community pharmacists by predialysis pharmacists and/or nurses when needed by the pharmacist during the stydied year.

1) Web-based interactive training program: It is entirely based on the PAIR criteria and is specifically designed to: a) familiarize community pharmacists with the PAIR criteria; and b) propose a systematic approach to detect/prevent/managed highly relevant DRPs included in the PAIR criteria. The Web-based program lasts about 60 minutes. After a brief overview of the pathophysiology of CKD, the 8 categories of the PAIR criteria are presented. Thereafter, 2 case studies are presented and the pharmacists are asked to consider each category of the PAIR criteria to detect and manage highly relevant DRPs and to complete a pharmaceutical opinion. As in real life, to do so, pharmacists have access to various tools and sources of information available within the ProFiL program: a) ProFiL clinical guide; b) ProFiL clinical summary including a list of health problems and medications as documented by the nephrologist as well as the GFR or CrCl result); c) pharmacy chart; d) direct interview with patient; and e) seamless-care service. The clinical guide includes all the information presented in the Web-based program, including the PAIR criteria, along with several clinical tools designed to facilitate the detection and management of highly relevant DRPs.
In this study, a Web discussion forum will be made available to ProFiL pharmacists. The seamless-care pharmacists will be responsible for preparing electronic case studies. Each one will present an actual ProFiL patient with highly relevant DRPs and describe its management within the ProFiL program. Pharmacists will be invited to comment on a Web fo-rum and will have the opportunity to ask questions and discuss issues of interest to them.
2) Communication-network program: It is designed to facilitate the transfer of clinical information between pharmacies and predialysis clinics. For each ProFiL patient, the community pharmacist will receive a clinical summary at baseline and month-12. It will include: a) a list of the patient’s medications as documented in the predialysis clinic chart; b) a list of the patient’s health problems; and c) the patient’s GFR or CrCl. The pre-dialysis clinicians (nephrologists, nurses and/or pharmacists) will be responsible for updating the list of medications and health problems. In addition, a pharmaceutical opinion form was specifically developed for CKD patients to facilitate the work of community pharmacist.
3) Seamless-care service: It will be offered from Monday to Friday during regular working hours by predialyis pharmacists and/or nurses from each clinic. Seamless-care clinicians will act as resource persons to answer questions from community pharmacists. They will also facilitate communication between the predialysis clinic and the community pharmacies. They will receive a copy of each pharmaceutical opinion, ensure that the community pharmacist’s recommendations are considered and provide appropriate feedback to the community pharmacist.
During the study, all seamless-care clinicians will record their interventions in a diary. For each communication they will record: a) the date; b) initials and number of patient; c) the initiator of the contact (pharmacist or seamless-care clinician); and d) a brief description of the discussion.
Intervention code [1] 257730 0
Other interventions
Comparator / control treatment
Usual care (UC) community pharmacists will not be able to access the Web-based training program, clinical guide, and discussion forum; the communication-network program; and the seamless-care service. However, at the end of the study, they will be invited to complete the training program and will be given a copy of the clinical guide
Control group
Active

Outcomes
Primary outcome [1] 259802 0
Compare the mean change in the number of highly relevant DRPs per patient, as defined by the PAIR criteria.
Timepoint [1] 259802 0
Between the baseline and the month-12 evaluations in ProFiL and UC patients.
Secondary outcome [1] 266111 0
The annual rate of DRPs resolution and appearance (as defined by the PAIR criteria).
Timepoint [1] 266111 0
Between the baseline and the month-12 evaluations in ProFiL and UC patients.
Secondary outcome [2] 266112 0
The proportion of patients having at least one highly relevant DRP.
Timepoint [2] 266112 0
At the month-12 evaluations in ProFiL and UC patients.
Secondary outcome [3] 266113 0
The annual mean number of pharmaceutical opinions issued per patient.
Timepoint [3] 266113 0
Between the baseline and the month-12 evaluations in ProFiL and UC patients.
Secondary outcome [4] 266114 0
The proportion of pharmacist recommendations implemented.
Timepoint [4] 266114 0
Between the baseline and the month-12 evaluations in ProFiL and UC patients.
Secondary outcome [5] 266115 0
The mean changes in kidney disease progression indicators (GFR, proteinuria) and CVD risk factors (low-density lipoprotein cholesterol, systolic and diastolic blood pressure, and glycosylated hemoglobin).
Timepoint [5] 266115 0
Between the baseline and the month-12 evaluations in ProFiL and UC patients.
Secondary outcome [6] 266120 0
The proportion of patients on dialysis.
Timepoint [6] 266120 0
At the month-12 evaluations in ProFiL and UC patients.
Secondary outcome [7] 266121 0
The proportion of comunity pharmacist who complete the Web-based interactive training program.
Timepoint [7] 266121 0
12 months after pharmacist entering the study.
Secondary outcome [8] 266122 0
Mean number of visits per pharmacist to Web discussion forum.
Timepoint [8] 266122 0
Between the baseline and the month-12 evaluations in ProFiL and UC pharmacists.
Secondary outcome [9] 266123 0
The change in knowledge/clinical competencies of pharmacists.
Timepoint [9] 266123 0
Between the baseline and the month-12 evaluations.
Secondary outcome [10] 268602 0
The satisfaction of ProFiL pharmacists on the Web-based interactive training program and Web discussion forum.
Timepoint [10] 268602 0
At the month-12 evaluations.
Secondary outcome [11] 273888 0
The proportion of DRPs categorised according to their level of severity.
Timepoint [11] 273888 0
At month-12 evaluations.

Eligibility
Key inclusion criteria
Patients: 1) have moderate (GFR: 30-59 ml/min/1.73 m2) or severe (GFR: 15-29 ml/min/1.73 m2) CKD based on the last laboratory test result performed; 2) are at least 18 years old; and 3) speak and read French or English; 4) have a eligible current community pharmacy that agrees to participate; 5) agree to continue being followed by their current community pharmacy for the duration of the study; and 6) are able to understand the study and provide informed consent. Patients will be excluded if they have a GFR < 15 ml/min/1.73 m2 or >59 ml/min/1.73 m2. Community pharmacy: 1) for pharmacies delivering >250 prescriptions per day: at least 60 hours are covered by participating pharmacists; OR for pharmacies delivering = 250 prescriptions per day at least 35 hours are covered by participating pharmacists; OR for pharmacies opened less than 7 days a week at least 50% of the opening hours are covered by participating pharmacists; 2) a pharmacist agrees to become in charge of the project in his/her pharmacy; 3) all participating pharmacists agree to complete the training program if assigned to the ProFiL group; 4) pharmacists agree to keep a copy of all pharmaceutical opinions issued during the study and to provide a copy of the patients’ pharmacy chart for the period covering the 12 months prior and after the baseline; 5) pharmacists working in more than one participating pharmacies agree to be assigned to the pharmacy where he/she is working most of the time; 6) a pharmacy can not recruit more than 20 patients. Finally, each participating pharmacy can only be randomized once.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients with a GFR less than 15ml/min/1,73m2 or more than 59ml/min/1,73m2 having dialysis at enrollment. All patients not fulfilling the inclusion criteria

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
454
Accrual to date
Final
Recruitment outside Australia
Country [1] 3002 0
Canada
State/province [1] 3002 0
Quebec

Funding & Sponsors
Funding source category [1] 258138 0
University
Name [1] 258138 0
Cercle du doyen
Country [1] 258138 0
Canada
Funding source category [2] 258139 0
Commercial sector/Industry
Name [2] 258139 0
Amgen Canada
Country [2] 258139 0
Canada
Funding source category [3] 258140 0
Other Collaborative groups
Name [3] 258140 0
Reseau Quebecois de recherche sur l'usage du medicament
Country [3] 258140 0
Canada
Funding source category [4] 264700 0
Government body
Name [4] 264700 0
Canadian Institutes of Health Research
Country [4] 264700 0
Canada
Funding source category [5] 264701 0
Commercial sector/Industry
Name [5] 264701 0
Leo Pharma Inc.
Country [5] 264701 0
Canada
Primary sponsor type
Government body
Name
Canadian Institutes of Health Research
Address
Room 97, 160 Elgin Street, Adress locator: 4809A Ottawa, (Ontario) K1A 0W9
Country
Canada
Secondary sponsor category [1] 257307 0
Commercial sector/Industry
Name [1] 257307 0
Amgen Canada
Address [1] 257307 0
6775, Financial Drive, bureau 100 Mississauga, Ontario, L5N 0A4
Country [1] 257307 0
Canada
Secondary sponsor category [2] 263832 0
Commercial sector/Industry
Name [2] 263832 0
Leo Pharma Inc.
Address [2] 263832 0
123, Commerce Valley Drive East, Suite 400 Thornhill, (Ontario) L3T 7W8
Country [2] 263832 0
Canada
Secondary sponsor category [3] 263833 0
University
Name [3] 263833 0
Cercle du doyen
Address [3] 263833 0
Faculty of pharmacy Universite de montreal C.P. 6128, Succ. Centre-ville Montreal, Quebec, H3C 3J7
Country [3] 263833 0
Canada
Other collaborator category [1] 251880 0
Other Collaborative groups
Name [1] 251880 0
Reseau Quebecois de recherche sur l'usage du medicament
Address [1] 251880 0
Unite de recherche en sante des populations Centre de recherche FRSQ du CHA de Quebec 1050, Chemin Ste-Foy Quebec (Quebec) G1S 4L8
Country [1] 251880 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260119 0
Sientific and Research Ethics Committee
Ethics committee address [1] 260119 0
Centre de sante et de services sociaux de Laval
1775, Rene-Laennec Blvd., Room D-S080
Laval (Quebec) H7M3L9
Ethics committee country [1] 260119 0
Canada
Date submitted for ethics approval [1] 260119 0
Approval date [1] 260119 0
18/10/2010
Ethics approval number [1] 260119 0

Summary
Brief summary
CONTEXT The chronic kidney disease (CKD) is an increasingly heavy burden societal. The pharmacist’s from pre-dialysis clinics can generally not offer pharmaceutical care constant to these customers, because of the limited resources. The Community pharmacist is thus the professional of choice to offer an effective follow-up and to collaborate in management the problems related to pharmacotherapy (PRPs). The ProFiL program is a training program and of connection in nephrology conceived in order to optimize the pharmaceutical care for the patients suffering from chronic kidney disease (CKD) without recourse to dialysis. A pilot study carried out beforehand suggests that the ProFiL program offers relevant tools to help the Community pharmacists to intervene more frequently and more effectively as for the prevention and the detection of PRPs at this population. OBJECTIVES ) To compare between groups Profile and SPH the average change of the full number of PRPs of the grid of Pharmacotherapy Analyzed in Impaired Renal function (PAIR) by patient, between the moment of the entry being studied and in 12 months of follow-up. 2) To compare between groups Profile and SPH: a) The quality of the use of the drugs (according to an analysis based on EVEN PRPs of the grid) b) The management of the pharmacothérapie (according to an analysis of the pharmaceutical opinions and refusal emitted for the patient by its Community pharmacist); c) Clinical variables (according to the comparison of certain clinical parameters: blood-pressure, cholesterol-LDL, glyquee haemoglobin (HbA1c), proteinurie, glomerular flow of filtration (DFG) and/or clearance of creatinin (Clcr)); d) the proportion of DRPs categorised based on their level of severity. 3) To evaluate the program Profile itself (according to the use of the clinical tools offered to the pharmacists of the Profile group, the evolution of knowledge/competences of the pharmacists and the satisfaction of the pharmacists as for the tools offered). METHOD Estimate: Open, pilot, multicentric clinical trial (6 pre-dialysis clinics), cluster randomized and controlled by parallel plan, to evaluate the impact of the program Profile on the quality of use of drugs. Study Groups: Cluster randomized with the Profile group or group SPH in a ratio 2:1 (thus 101 pharmacies Profile, 50 pharmacies SPH). The ProFiL program comprises an aspect of Web formation and a liaison department with the private clinic of pre-dialysis. The pharmacists assigned with group SPH will have access to the ProFiL program when the study is finished. Analysis: The analysis will be done as intent-to-treat. RELEVANCE The model of collaboration between hospital and community pharmacists proposed is single, simple and rests primarily on principles of formation and communication. If it proves to be efficient, it could be used like a model of reference in the management of the chronic diseases and could be applied to other types of private clinics with ambulatory customers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31837 0
Address 31837 0
Country 31837 0
Phone 31837 0
Fax 31837 0
Email 31837 0
Contact person for public queries
Name 15084 0
Dr Lyne Lalonde
Address 15084 0
Faculty of Pharmacy, Universite de Montreal,
Pavillon Jean-Coutu,
2940 chemin de la Polytechnique, bureau 2238,
Montreal (Quebec), H3T 1J4
Country 15084 0
Canada
Phone 15084 0
450-668-1010 ext. 23710
Fax 15084 0
Email 15084 0
[email protected]
Contact person for scientific queries
Name 6012 0
Dr Lyne Lalonde
Address 6012 0
Faculty of Pharmacy, Universite de Montreal,
Pavillon Jean-Coutu,
2940 chemin de la Polytechnique, bureau 2238,
Montreal (Quebec), H3T 1J4
Country 6012 0
Canada
Phone 6012 0
450-668-1010 ext. 23710
Fax 6012 0
Email 6012 0
[email protected]

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