TRANSforming InTerprofessional Cardiovascular Prevention in Primary Care

Study Overview
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Brief Summary
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The TRANSIT program is a program to TRANSform InTerprofessional clinical practices to improve cardiovascular prevention in primary care. It addresses priorities in primary care relevant to the Chronic Care Model (Wagner 2001): self-management support, delivery-system design, and management of clinical information. The program includes : a case manager to coordinate and provide care and follow up; clinical protocols and tools to support interprofessional and systematic follow up; training for clinicians; patient's personalized cardiovascular health booklet; tools to promote group sessions for patient education on cholesterol, hypertension, and diabetes. The general OBJECTIVE of this trial is to evaluate and compare two STRATEGIES for implementing the TRANSIT program in Family Medicine Groups (FMGs): facilitation, and passive diffusion. Passive diffusion is the usual strategy where clinicians implement an intervention program by themselves. Facilitation is a strategy whereby a facilitator provides support to a team of clinicians to help them introduce the changes required to implement the program into practice. The hypothesis is that facilitation will be more efficacious to implement the program than passive diffusion: it will enhance the provision of cardiovascular preventive care; it will enhance interprofessional collaboration; it will enable more efficaciously the implementation of new clinical processes; it will improve patient clinical outcomes; it will cost more in the short term, but will have positive economic impact in the long term; there will be less undesired effects of all types related to implementation. To test the hypothesis, we assess the efficacy of the implementation strategies to enhance interprofessional collaboration and better support patients in the management of their conditions. Impact on provision of care, interprofessional collaboration, clinical processes, and patient clinical outcomes (values, therapeutic targets, and lifestyle habits) will be evaluated. Moreover, the implementation cost related to each strategy will be estimated. We complement the trial with qualitative methods to document the perceptions of clinicians, facilitators, patients and members of the family regarding the TRANSIT program, the implementation strategies and the observed changes in the clinical practices and outcomes.

Detailed Description
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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.

Official Title
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A Program to TRANSform InTerprofessional Clinical Practices to Improve Cardiovascular Prevention in Primary Care

Conditions
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Diabetes Mellitus, Type 2, Hypertension, Dyslipidemias, Cholesterol, LDL, Comorbitdity

Intervention / Treatment
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* Other: Facilitation
* Other: Passive diffusion


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Facilitation<br>Facilitation is a change management process. In the TRANSIT study, the change consist in implementing the TRANSIT program in primary care clinics. In the facilitation group, external facilitators accompany, support, and empower clinical teams so they quickly develop a sense of ownership regarding new clinical practices and sustainably implement them with lower costs. External facilitators offer counseling, coaching, and various tools to an internal facilitation team composed of clinicians of the clinical team to support their efforts in implementing change in their practices. Facilitation activities are structured in a cycle of 4 steps, the Plan-Do-Study-Act cycle (PDSA cycle). | Other: Facilitation<br>* Facilitation is a change management process. In the TRANSIT study, the change consist in implementing the TRANSIT program in primary care clinics. In the facilitation group, external facilitators accompany, support, and empower clinical teams so they quickly develop a sense of ownership regarding new clinical practices and sustainably implement them with lower costs. External facilitators offer counseling, coaching, and various tools to an internal facilitation team composed of clinicians of the clinical team to support their efforts in implementing change in their practices. Facilitation activities are structured in a cycle of 4 steps, the Plan-Do-Study-Act cycle (PDSA cycle).<br>* Other names: Plan-Do-Study-Act cycles (PDSA cycles);|
| Active Comparator: Passive diffusion<br>Clinical teams in primary care clinics implement the TRANSIT program without the help of facilitators. | Other: Passive diffusion<br>* Clinical teams in primary care clinics implement the TRANSIT program without the help of facilitators.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of the cardiovascular preventive care | Mean change in the composite score of the quality of the cardiovascular preventive care | Baseline and 12 months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Organisational outcomes | Impact of implementation strategy on: clinicians' and patients' perception of health service delivery (questionnaires: ACIC and PACIC); team work (questionnaire: TCI - short version); clinicians' perception of achievement of change (questionnaires: Herscovitch and Meyer's Affective Engagement, Bandura's Self Efficacy, and clinician's perception of achievement of the TRANSIT program [after 12 months only]); direct costs (clinician time and compensations for participation in facilitation activities, salary and training of the external facilitator). | Baseline and 12 months after randomization | 
| Blood pressure | Mean change in the systolic/diastolic blood pressure | Baseline and 12 months after randomization | 
| c-LDL | Mean change in change in the c-LDL | Baseline and 12 months after randomization | 
| Glycosylated hemoglobine (HgA1c) | Mean change in the HgA1c | Baseline and 12 months after randomization | 
| Achieved therapeutic targets | Mean change in percentage of achieved therapeutic targets | Baseline and 12 months after randomization | 
| Lifestyle habits | Mean change in lifestyle habits as measured using self-administered questionnaires to patients : Hopkin's food frequency questionnaire, International Physical Activity Questionnaire (IPAQ), smoking status | Baseline and 12 months after randomization | 
| Use of public programs | Mean change in percentage of patients using the education programs and in mean frequency of use. Programs are education to patients on diabetes, cholesterol, hypertension, and healthy weight control | Baseline and 12 months after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Disease Management, Quality Improvement, Cooperative Behavior (collaboration)