TRANSforming InTerprofessional Cardiovascular Prevention in Primary Care (TRANSIT)

February 15, 2017 updated by: Lyne Lalonde, Fonds de la Recherche en Santé du Québec

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

759

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Laval, Quebec, Canada, H7M 3L9
        • Centre de santé et de services sociaux de Laval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Facilitation
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
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 Names:
  • Plan-Do-Study-Act cycles (PDSA cycles)
ACTIVE_COMPARATOR: Passive diffusion
Clinical teams in primary care clinics implement the TRANSIT program without the help of facilitators.
Other: Passive diffusion
Clinical teams in primary care clinics implement the TRANSIT program without the help of facilitators.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of the cardiovascular preventive care
Time Frame: Baseline and 12 months after randomization
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
Time Frame: Baseline and 12 months after randomization

Impact of implementation strategy on:

  1. clinicians' and patients' perception of health service delivery (questionnaires: ACIC and PACIC);
  2. team work (questionnaire: TCI - short version);
  3. 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]);
  4. 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
Time Frame: Baseline and 12 months after randomization
Mean change in the systolic/diastolic blood pressure
Baseline and 12 months after randomization
c-LDL
Time Frame: Baseline and 12 months after randomization
Mean change in change in the c-LDL
Baseline and 12 months after randomization
Glycosylated hemoglobine (HgA1c)
Time Frame: Baseline and 12 months after randomization
Mean change in the HgA1c
Baseline and 12 months after randomization
Achieved therapeutic targets
Time Frame: Baseline and 12 months after randomization
Mean change in percentage of achieved therapeutic targets
Baseline and 12 months after randomization
Lifestyle habits
Time Frame: Baseline and 12 months after randomization
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
Time Frame: Baseline and 12 months after randomization
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fonds de la Recherche en Santé du Québec

Collaborators

Université de Montréal

Investigators

  • Principal Investigator: Lyne Lalonde, Ph.D., Centre de santé et de services sociaux de Laval ; University of Montreal
  • Principal Investigator: Johanne Goudreau, Ph.D., Université de Montréal
  • Principal Investigator: Céline Bareil, Ph.D., HEC Montréal
  • Principal Investigator: Éveline Hudon, M.D., Université de Montréal
  • Principal Investigator: Fabie Duhamel, Ph.D., Université de Montréal
  • Principal Investigator: Marie-Thérèse Lussier, M.D., Université de Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

August 16, 2011

First Submitted That Met QC Criteria

August 16, 2011

First Posted (ESTIMATE)

August 17, 2011

Study Record Updates

Last Update Posted (ACTUAL)

February 17, 2017

Last Update Submitted That Met QC Criteria

February 15, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRSQ-22424

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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