Clinical trial NCT01418716: TRANSforming InTerprofessional Cardiovascular Prevention in Primary Care
Official title: A Program to TRANSform InTerprofessional Clinical Practices to Improve Cardiovascular Prevention in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Hypertension
Dyslipidemias
Cholesterol, LDL
Comorbitdity
Keywords: Disease Management
Quality Improvement
Cooperative Behavior (collaboration)
Lead sponsor: Fonds de la Recherche en Santé du Québec
Sponsor class: OTHER_GOV
Collaborators: name: Université de Montréal
First posted: 2011-08-17
Enrollment: 759
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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):

1. facilitation, and
2. 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: 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:

1. 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;
2. 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;
3. a room is available for the case manager nurse for the equivalent of one day/week over 15 months;
4. 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Quality of the cardiovascular preventive care
timeFrame: Baseline and 12 months after randomization
Secondary outcomes:
measure: Organisational outcomes
timeFrame: Baseline and 12 months after randomization
measure: Blood pressure
timeFrame: Baseline and 12 months after randomization
measure: c-LDL
timeFrame: Baseline and 12 months after randomization
measure: Glycosylated hemoglobine (HgA1c)
timeFrame: Baseline and 12 months after randomization
measure: Achieved therapeutic targets
timeFrame: Baseline and 12 months after randomization
measure: Lifestyle habits
timeFrame: Baseline and 12 months after randomization
measure: Use of public programs
timeFrame: Baseline and 12 months after randomization
Other outcomes:
Locations:
city: Laval
country: Canada
facility: Centre de santé et de services sociaux de Laval
state: Quebec
Study officials:
affiliation: Centre de santé et de services sociaux de Laval ; University of Montreal
name: Lyne Lalonde, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Montréal
name: Johanne Goudreau, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: HEC Montréal
name: Céline Bareil, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Montréal
name: Éveline Hudon, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Montréal
name: Fabie Duhamel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Montréal
name: Marie-Thérèse Lussier, M.D.
role: PRINCIPAL_INVESTIGATOR
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citation: Lalonde L, Goudreau J, Hudon E, Lussier MT, Bareil C, Duhamel F, Levesque L, Turcotte A, Lalonde G; Group for TRANSIT to Best Practices in Cardiovascular Disease Prevention in Primary Care. Development of an interprofessional program for cardiovascular prevention in primary care: A participatory research approach. SAGE Open Med. 2014 Feb 17;2:2050312114522788. doi: 10.1177/2050312114522788. eCollection 2014.