Contact information
Type
Scientific
Primary contact
Dr Lyne Lalonde
ORCID ID
Contact details
Équipe de recherche
Soins de première ligne
Centre de santé et de services sociaux de Laval (Cité de la Santé de Laval)
1755 René-Laennec
Local D-S145
Laval
H7M 3L9
Canada
+1 514 343 6111 ext. 5315
lyne.lalonde@umontreal.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
UCT-58955
Study information
Scientific title
Optimising thromboembolic and stroke prevention: a randomised controlled trial of pharmacist-managed oral anticoagulotherapy
Acronym
PHARMA
Study hypothesis
Compared to the centralised care model, the integrated care model may be associated with similar anticoagulation control, similar incidence of major haemorrhagic and thromboembolic events and similar patients quality of life. However, the integrated care may represent a more efficient use of the health-care system. It may be less costly.
Ethics approval
Cité de la Santé de Laval, Comité d'éthique et de la recherche (conditional approval of the project: 18th December 2001). Full approval as on 12th November 2002 until 11th November 2003; amendments to the protocol made on 16th September 2003. Reapprobation of the project on the following dates:
18th November 2003: reapprobation of the project until 11th November 2004
9th October 2004: reapprobation of the project until 15th September 2005
11th October 2005: reapprobation of the project until 11th November 2006
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Thromboembolism and stroke
Intervention
A three-year randomised controlled trial (RCT) will be conducted. All patients registering at the PMAS with a first prescription of warfarin for a minimum of six months and who agree to participate (n = 500) will be randomised to the integrated or the centralised PMAS model of care.
Integrated care model: Patients will be monitored by PMAS pharmacists until stabilisation of their international normalised ratio (INR) within their prescribed therapeutic range (six to eight weeks). Thereafter, they will be transferred to their treating physician.
Centralised care model: Patients will be monitored by PMAS for the entire duration of the study.
All patients will be followed for a total of six months. We will monitor the quality of INR control, the incidence of major thromboembolic and haemorrhagic events, the patients health-related quality of life, and direct health-care costs associated with each model of care.
Intervention type
Drug
Phase
Not Applicable
Drug names
Warfarin
Primary outcome measure
The percentage of time spent within the target INR range.
Secondary outcome measures
1. Incidence and severity of major thromboembolic and haemorrhagic events
2. Health-related quality of life
3. Direct medical-care costs
Overall trial start date
01/01/2001
Overall trial end date
31/03/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. The patient is referred to the Pharmacy Managed Anticoagulation Service (PMAS) with a prescription of warfarin for at least six months
2. The patient is aged 18 years and older, either sex
3. The patient agrees to go to the Cité de la Santé de Laval, the Centre Hospitalier Ambulatoire Régional de Laval, or one of the four Laval Centre Local de Services Communautaire for blood drawing during participation in the study (six months)
4. The patient lives in the Laval area
5. The patient is able to read and speak French or English
6. The patient agrees to participate in the study and has signed the informed consent form
7. The patient's treating physician has agreed to participate and has signed the informed consent form
8. It is expected that the patient will be transferred to the treating physician
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
500
Participant exclusion criteria
1. The patient participates to another study
2. The patient is referred to the PMAS for a pre-admission
Recruitment start date
01/01/2001
Recruitment end date
31/03/2005
Locations
Countries of recruitment
Canada
Trial participating centre
Équipe de recherche
Laval
H7M 3L9
Canada
Sponsor information
Organisation
Cité de la Santé de Laval (Canada)
Sponsor details
University of Montreal
Laval
H3C 3J7
Canada
Sponsor type
Government
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: UCT-58955)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Taro Pharmaceutical Inc. (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18585510
Publication citations
-
Results
Lalonde L, Martineau J, Blais N, Montigny M, Ginsberg J, Fournier M, Berbiche D, Vanier MC, Blais L, Perreault S, Rodrigues I, Is long-term pharmacist-managed anticoagulation service efficient? A pragmatic randomized controlled trial., Am. Heart J., 2008, 156, 1, 148-154, doi: 10.1016/j.ahj.2008.02.009.