TRANSforming InTerprofessional Cardiovascular Prevention in Primary Care (TRANSIT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Université de Montréal
Information provided by (Responsible Party):
Lyne Lalonde, Fonds de la Recherche en Santé du Québec
ClinicalTrials.gov Identifier:
NCT01418716
First received: August 16, 2011
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

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 nurse to coordinate and provide care and follow up;
  • clinical protocols and tools to support interprofessional and systematic follow up;
  • training for clinicians to use the electronic directory of regional health resources;
  • patient's personalized cardiovascular health booklet;
  • training for clinicians to perform motivational interviews;
  • 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.


Condition Intervention
Diabetes Mellitus, Type 2
Hypertension
Dyslipidemias
Cholesterol, LDL
Comorbitdity
Other: Facilitation
Other: Passive diffusion (usual implementation strategy)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Program to TRANSform InTerprofessional Clinical Practices to Improve Cardiovascular Prevention in Primary Care

Resource links provided by NLM:


Further study details as provided by Fonds de la Recherche en Santé du Québec:

Primary Outcome Measures:
  • Quality of the cardiovascular preventive care [ Time Frame: Baseline and 12 months after randomization ] [ Designated as safety issue: No ]
    Mean change in the composite score of the quality of the cardiovascular preventive care


Secondary Outcome Measures:
  • Organisational outcomes [ Time Frame: Baseline and 12 months after randomization ] [ Designated as safety issue: No ]

    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).

  • Blood pressure [ Time Frame: Baseline and 12 months after randomization ] [ Designated as safety issue: No ]
    Mean change in the systolic/diastolic blood pressure

  • c-LDL [ Time Frame: Baseline and 12 months after randomization ] [ Designated as safety issue: No ]
    Mean change in change in the c-LDL

  • Glycosylated hemoglobine (HgA1c) [ Time Frame: Baseline and 12 months after randomization ] [ Designated as safety issue: No ]
    Mean change in the HgA1c

  • Achieved therapeutic targets [ Time Frame: Baseline and 12 months after randomization ] [ Designated as safety issue: No ]
    Mean change in percentage of achieved therapeutic targets

  • Lifestyle habits [ Time Frame: Baseline and 12 months after randomization ] [ Designated as safety issue: No ]
    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

  • Use of public programs [ Time Frame: Baseline and 12 months after randomization ] [ Designated as safety issue: No ]
    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


Enrollment: 759
Study Start Date: April 2011
Estimated Study Completion Date: June 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Facilitation 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 Name: Plan-Do-Study-Act cycles (PDSA cycles)
Active Comparator: Passive diffusion Other: Passive diffusion (usual implementation strategy)
Clinical teams in primary care clinics implement the TRANSIT program without the help of facilitators.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01418716

Locations
Canada, Quebec
Centre de santé et de services sociaux de Laval
Laval, Quebec, Canada, H7M 3L9
Sponsors and Collaborators
Fonds de la Recherche en Santé du Québec
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
  More Information

Additional Information:
Publications:

Responsible Party: Lyne Lalonde, Professor (professeur agrégé), Fonds de la Recherche en Santé du Québec
ClinicalTrials.gov Identifier: NCT01418716     History of Changes
Other Study ID Numbers: FRSQ-22424
Study First Received: August 16, 2011
Last Updated: May 2, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Fonds de la Recherche en Santé du Québec:
Disease Management
Quality Improvement
Cooperative Behavior (collaboration)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Dyslipidemias
Hypertension
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014