TRANSforming InTerprofessional Cardiovascular Prevention in Primary Care

STUDY DESIGN:

Pragmatic cluster randomized clinical trial

SETTING:

Nine Family Medicine Groups (FMGs) take part in the study. FMGs are primary care clinics delivering family medicine services. They include physicians and nurses, and collaborate with other health professionals.

Eligible FMGs meet the following criteria:

• 2 physicians, 1 nurse, 1 community pharmacist, 1 member of the medical administrative support, and 1 other health professional (nutritionist, kinesiologist, or psychologist) accept to participate by collaborating to the facilitation activities, if the FMG is assigned to the facilitation group;
• 1 physician, 1 nurse, 1 community pharmacist and 1 other health professional (nutritionist, psychologist, kinesiologist) accept to play a role in the internal facilitation team, if the FMG is assigned to the facilitation group;
• a room is available for the case manager nurse for the equivalent of one day/week over 15 months;
• 100 eligible patients accept to participate in the study, with a minimum of 15 patients per physician participant.

All FMGs in the TRANSIT study are given access to the TRANSIT program, to the supportive clinical tools cliniques, and to a case manager nurse. Training will be offered on the use of the electronic directory of health resources and on motivational interview.

RANDOMIZATION:

Prior to randomization, each clinician is assigned to one FMG only. Each FMG will be paired with 2 others of the same level of CVD preventive care (score <6 or ≥6), as estimated with the questionnaire "Assessment of Chronic Illness Care" (ACIC). Usually, medical clinics report a score of 5 or less at baseline.

Participating FMGs (n=9) will be randomly assigned to facilitation (n=6) and to passive diffusion (n=3). FMGs will be randomized simultaniously in blocs of 3. For each bloc, 2:1 ratio (facilitation:passive diffusion) will be respected. Randomization will be stratified in fonction of the ACIC score (score <6 or score ≥6). Because of the small number of participating FMGs, grouping GMFs in blocs of 3 according to the ACIC score will ensure complete blocs are found in each randomization stratum.

ANALYSIS:

For all variables, multivariable analysis models taking account the intracluster correlation (linear/SAS PROC MIXED) for continuous and categorical variables (logistic/PROC GENMOD) will be developed. Significative variables (p<0.2) in bivariable model including the study group will be included in the multivariable model. We will then apply a backward selection procedure and include in the final model those variables that were statistically significant at p < 0.1.

Inclusion criteria

• patient is registered in a Family Medicine Group;
• 10-year Framingham risk score (FRS) moderate (11-19%) to high (≥ 20%);
• at least one of the following condition uncontrolled:

• Diabetes: HbA1C > 7% OR fasting blood glucose > 7 mmol/L OR 2-hour postprandial blood glucose > 10 mmol/L (OR > 8 mmol/L if HbA1C target is not acheived)(Canadian Diabetes Association Clinical Practice Guidelines Expert Committee, Canadian Journal of Diabetes, 2008)
• Dyslipidemia: C-LDL ≥ 2 mmol/L in moderate to high risk patients OR less than 50% reduction of C-LDL compared to initial value OR Apo-B ≥ 0,8 g/L (Genest, McPherson et al. 2009)
• Hypertension: blood pressure ≥ 140/90 ou ≥ 130/80 in diabetic patients or with chronic kidney disease (TFG < 60mL/min/1,73m2; (Cloutier & Poirier 2011)
• Patient with at least two chronic disease or chronic health problem other than type II diabetes, dyslipidemia, hypertension, or cardiovascular disease (e.g. : angina, previous history of myocard infarct, stroke, and intermittent claudication).

Exclusion criteria

• Patient followed for a cardiovascular disease in a specialized clinic in secondary care (ex.: cardiology, endocrinology etc).