Condition category
Circulatory System
Date applied
05/09/2005
Date assigned
05/09/2005
Last edited
11/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 patient’s 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 patient’s 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 measures

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

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

http://www.cssslaval.qc.ca/

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

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18585510

Publication citations

  1. 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.

Additional files

Editorial Notes