Impact of pharmacists ACCESs to clinical information on the quality and the continuity of care in poly-medicamented community patients: a randomised controlled trial

ISRCTN ISRCTN74420611
DOI https://doi.org/10.1186/ISRCTN74420611
Secondary identifying numbers N/A
Submission date
16/04/2008
Registration date
18/06/2008
Last edited
18/06/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Lyne Lalonde
Scientific

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

Phone +1 450 668 1010 ext. 2743
Email lyne.lalonde@umontreal.ca

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronymACCES
Study objectivesDrug-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(s)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.
Health condition(s) or problem(s) studiedDrug-related problems from multiple prescription drugs
InterventionAll 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 typeOther
Primary outcome measureThe 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 measuresThe 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 study start date01/10/2007
Completion date24/04/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants170
Key inclusion criteriaFamily 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
Key exclusion criteria1. 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
Date of first enrolment01/10/2007
Date of final enrolment24/04/2008

Locations

Countries of recruitment

  • Canada

Study participating centre

Resaerch Team in Primary Care
Laval
H7M 3L9
Canada

Sponsor information

Pfizer (Canada)
Industry

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

Phone +1 450 466 3952
Email Chideh.Motallebi@Pfizer.com
Website http://www.pfizer.ca
ROR logo "ROR" https://ror.org/059g90c15

Funders

Funder type

Industry

Pfizer (Canada)
Government organisation / For-profit companies (industry)
Alternative name(s)
Pfizer Inc., Pfizer Consumer Healthcare, Davis, Charles Pfizer & Company, Warner-Lambert, King Pharmaceuticals, Wyeth Pharmaceuticals, Seagen
Location
United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan