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Diabetes Mellitus, Type 2TRANSITNCT01418716

TRANSforming InTerprofessional Cardiovascular Prevention in Primary Care

A study testing Facilitation and Passive diffusion in people with Diabetes Mellitus, Type 2 and Hypertension, run by Fonds de la Recherche en Santé du Québec at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Facilitation and Passive diffusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
759 participants
Where
1 siteCanada
Study dates
Apr 2011to Oct 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre de santé et de services sociaux de Laval

    Laval, Quebec, H7M 3L9

Other trials in Canada

About this study

Official title: 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 :

Read more
  • 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.

Read the 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.

Being tested
Facilitation, Passive diffusion
Keywords
Disease Management, Quality Improvement, Cooperative Behavior (collaboration)
Medical subject headings
Diabetes Mellitus, Type 2, Hypertension, Dyslipidemias, Cooperative Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FacilitationOther

    Also called Plan-Do-Study-Act cycles (PDSA cycles)

    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).

  • Passive diffusionOther

    Clinical teams in primary care clinics implement the TRANSIT program without the help of facilitators.

Study groups in NCT01418716
Study groupRoleWhat they receive
FacilitationExperimentalFacilitation 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).
Receives: Other: Facilitation
Passive diffusionActive comparatorClinical teams in primary care clinics implement the TRANSIT program without the help of facilitators.
Receives: Other: Passive diffusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of the cardiovascular preventive care

    Mean change in the composite score of the quality of the cardiovascular preventive care

    Measured: Baseline and 12 months after randomization

Secondary outcomes (7)

  1. Organisational outcomes

    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).

    Measured: Baseline and 12 months after randomization

  2. Blood pressure

    Mean change in the systolic/diastolic blood pressure

    Measured: Baseline and 12 months after randomization

  3. c-LDL

    Mean change in change in the c-LDL

    Measured: Baseline and 12 months after randomization

  4. Glycosylated hemoglobine (HgA1c)

    Mean change in the HgA1c

    Measured: Baseline and 12 months after randomization

  5. Achieved therapeutic targets

    Mean change in percentage of achieved therapeutic targets

    Measured: Baseline and 12 months after randomization

  6. 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

    Measured: Baseline and 12 months after randomization

  7. 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

    Measured: Baseline and 12 months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionOct 2013
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
759 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01418716
Sponsor's protocol ID
FRSQ-22424
Acronym
TRANSIT
Status last verified
Feb 2017
First submitted
16 Aug 2011
Last updated
17 Feb 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Wagner EH, Austin BT, Davis C, Hindmarsh M, Schaefer J, Bonomi A. Improving chronic illness care: translating evidence into action. Health Aff (Millwood). 2001 Nov-Dec;20(6):64-78. doi: 10.1377/hlthaff.20.6.64.

    PubMed 11816692

  • Dogherty EJ, Harrison MB, Graham ID. Facilitation as a role and process in achieving evidence-based practice in nursing: a focused review of concept and meaning. Worldviews Evid Based Nurs. 2010 Jun 1;7(2):76-89. doi: 10.1111/j.1741-6787.2010.00186.x. Epub 2010 Feb 19.

    PubMed 20180826

  • Nagykaldi Z, Mold JW, Robinson A, Niebauer L, Ford A. Practice facilitators and practice-based research networks. J Am Board Fam Med. 2006 Sep-Oct;19(5):506-10. doi: 10.3122/jabfm.19.5.506.

    PubMed 16951300

  • Genest J, McPherson R, Frohlich J, Anderson T, Campbell N, Carpentier A, Couture P, Dufour R, Fodor G, Francis GA, Grover S, Gupta M, Hegele RA, Lau DC, Leiter L, Lewis GF, Lonn E, Mancini GB, Ng D, Pearson GJ, Sniderman A, Stone JA, Ur E. 2009 Canadian Cardiovascular Society/Canadian guidelines for the diagnosis and treatment of dyslipidemia and prevention of cardiovascular disease in the adult - 2009 recommendations. Can J Cardiol. 2009 Oct;25(10):567-79. doi: 10.1016/s0828-282x(09)70715-9.

    PubMed 19812802

  • Hackam DG, Khan NA, Hemmelgarn BR, Rabkin SW, Touyz RM, Campbell NR, Padwal R, Campbell TS, Lindsay MP, Hill MD, Quinn RR, Mahon JL, Herman RJ, Schiffrin EL, Ruzicka M, Larochelle P, Feldman RD, Lebel M, Poirier L, Arnold JM, Moe GW, Howlett JG, Trudeau L, Bacon SL, Petrella RJ, Milot A, Stone JA, Drouin D, Boulanger JM, Sharma M, Hamet P, Fodor G, Dresser GK, Carruthers SG, Pylypchuk G, Burgess ED, Burns KD, Vallee M, Prasad GV, Gilbert RE, Leiter LA, Jones C, Ogilvie RI, Woo V, McFarlane PA, Hegele RA, Tobe SW; Canadian Hypertension Education Program. The 2010 Canadian Hypertension Education Program recommendations for the management of hypertension: part 2 - therapy. Can J Cardiol. 2010 May;26(5):249-58. doi: 10.1016/s0828-282x(10)70379-2.

    PubMed 20485689

  • Fortin M, Soubhi H, Hudon C, Bayliss EA, van den Akker M. Multimorbidity's many challenges. BMJ. 2007 May 19;334(7602):1016-7. doi: 10.1136/bmj.39201.463819.2C.

    PubMed 17510108

  • Lalonde L, Goudreau J, Hudon E, Lussier MT, Duhamel F, Belanger D, Levesque L, Martin E; Group for TRANSIT to Best Practices in Cardiovascular Disease Prevention in Primary Care. Priorities for action to improve cardiovascular preventive care of patients with multimorbid conditions in primary care--a participatory action research project. Fam Pract. 2012 Dec;29(6):733-41. doi: 10.1093/fampra/cms021. Epub 2012 Feb 29.

    PubMed 22379187

  • 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.

    PubMed 26770705

Questions about this trial

What is this clinical trial studying?

A study testing Facilitation and Passive diffusion in people with Diabetes Mellitus, Type 2 and Hypertension, run by Fonds de la Recherche en Santé du Québec at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of the cardiovascular preventive care (time frame: Baseline and 12 months after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01418716, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2017; AzTrials last refreshed its copy on 4 Nov 2026.

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