Ambulatory integrated primary care management program for patients with dyslipidaemia

ISRCTN	ISRCTN66345533
DOI	https://doi.org/10.1186/ISRCTN66345533
Secondary identifying numbers	MCT-75427

Submission date: 09/08/2005
Registration date: 09/08/2005
Last edited: 16/04/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Lyne Lalonde
Scientific

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, Quebec
H7M 3L9
Canada

Phone	+1 514 343 6111 ext. 5315
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	Treatment
Scientific title	Randomised controlled trial to evaluate an ambulatory integrated primary care management program for patients with dyslipidaemia: TEAM Study
Study acronym	TEAM
Study objectives	Compared to the usual care (UC) patients, those assigned to the integrated primary care (IPC) intervention will have a larger reduction in low-density lipoprotein cholesterol (LDL-C) and more patients will achieve the recommended target lipid levels.
Ethics approval(s)	Ethics and research committee of the Laval Health and Social Service Centre gave approval on the 19th October 2004
Health condition(s) or problem(s) studied	Dyslipidaemia
Intervention	In the integrated primary care (IPC) intervention, family physicians will be responsible for the diagnosis and prescription of the statin treatment. Thereafter, the pharmacists will be responsible for monitoring the effectiveness and safety of the treatment. They will be allowed to request laboratory tests at predetermined time intervals and perform protocol-driven dosage adjustments. In the usual care (UC) intervention, physicians and pharmacists will receive no instructions regarding the type and frequency of patient visits.
Intervention type	Other
Primary outcome measure	Mean change in LDL-C from baseline to month 12
Secondary outcome measures	1. Achievement of the recommended target lipid levels, TC, HDL-C, TC/HDL-C, triglyceride, blood pressure, body mass index, fasting blood glucose, adherence and persistence to statin treatment, patient satisfaction, knowledge and decisional conflict, professionals' satisfaction 2. Application of the IPC intervention
Overall study start date	01/02/2006
Completion date	01/01/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	224
Key inclusion criteria	1. Aged greater than or equal to 18 years, either sex 2. Speak and read French or English 3. Are able to give informed consent and understand and follow study procedures 4. Agree to participate and sign the informed consent 5. According to the results of their last laboratory tests (performed in the previous three months), are candidate for initiating statin monotherapy or are currently on statin monotherapy at a non-optimal dose and are not adequately controlled according to one of the following criteria: 5.1. High risk (10-year coronary heart disease [CHD] risk greater than 20%): LDL-C greater than 2.5 mmol/l and total cholesterol (TC):high-density lipoprotein (HDL-C) ratio greater than 4 5.2. Moderate risk (10-year CHD risk between 11 - 19%): LDL-C greater than 3.5 mmol/l and TC:HDL-C ratio greater than 5 6. Agree to be followed by one of the participating family physicians and one of the pharmacists for the duration of the study (12 months) 7. IPC physician agrees to refer the patient to a participating pharmacist for dyslipidaemia-treatment follow-up 8. Physician agrees to delay the beginning or change of pharmacotherapy until the initial study visit 9. Patients are not patients of a particular pharmacy or report being patients of one of the participating pharmacies
Key exclusion criteria	1. Patients already taking lipid-lowering medication and adequately controlled according to the most recent Canadian guidelines for the treatment of dyslipidaemia 2. Patients taking more than one lipid-lowering medication 3. Patients with acute cardiovascular disease (CVD) event (e.g. myocardial infarction, stroke and revascularisation) in the previous 6 months 4. Patients with a life-threatening disease or another health condition (severe mental problems, chronic alcoholism, renal insufficiency [creatinine clearance less than 60 ml/min], hepatic insufficiency [aspartate aminotransferase {AST}, alanine aminotransferase {ALT} greater than 3 x the upper normal limit] etc.) that, according to the referring physician, make them unlikely to complete the study 5. Patient with triglyceride greater than 5 mmol/l 6. Patient with LDL-C greater than 5 mmol/l 7. Patient with contraindication to statin medication (elevated transaminase levels [AST or ALT greater than 3 x the upper normal limit], history of myalgia with creatinine kinase [CK] greater than 10 x the upper normal limit) 8. Participating in another clinical trial
Date of first enrolment	01/02/2006
Date of final enrolment	01/01/2008

Locations

Countries of recruitment

Canada

Study participating centre

Équipe de recherche

Laval, Quebec
H7M 3L9
Canada

Sponsor information

University of Montreal (Canada)
University/education

Faculté de Pharmacie
Université de Montréal
C.P. 6128
Succursale Centre-ville
Montreal, Quebec
H3C 3J7
Canada

Phone	+1 514 343 7497
Email	sophie.brisbois@umontreal.ca
Website	http://www.umontreal.ca/english/
"ROR"	https://ror.org/0161xgx34

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-75427)

No information available

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	23/03/2010		Yes	No