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 design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronym	ACCES
Study objectives	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(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) studied	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
Primary outcome measure	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 Clinics pharmacists in both groups
Overall study start date	01/10/2007
Completion date	24/04/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	170
Key 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
Key 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
Date of first enrolment	01/10/2007
Date of final enrolment	24/04/2008

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"	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 share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan