Condition category
Signs and Symptoms
Date applied
16/04/2008
Date assigned
18/06/2008
Last edited
18/06/2008
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

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 Clinic’s 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

http://www.pfizer.ca

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

Publication citations

Additional files

Editorial Notes