TRANSforming InTerprofessional Cardiovascular Prevention in Primary Care

NCT01418716 | Completed

• 1 other identifier: FRSQ-22424
• Study Type: interventional
• Target: 759
• Locations: 1 country
• Sites: 1

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):
• facilitation, and
• 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.

Conditions

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

Keywords

Disease Management; Quality Improvement; Cooperative Behavior (collaboration)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Organisational outcomes

  Baseline and 12 months after randomization

• Blood pressure

  Baseline and 12 months after randomization

• c-LDL

  Baseline and 12 months after randomization

• Glycosylated hemoglobine (HgA1c)

  Baseline and 12 months after randomization

• Achieved therapeutic targets

  Baseline and 12 months after randomization

Study Arms (2)

Facilitation

EXPERIMENTAL

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

Passive diffusion

ACTIVE COMPARATOR

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

Other: Passive diffusion

Interventions

Facilitation OTHER

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).

Also known as: Plan-Do-Study-Act cycles (PDSA cycles)

Facilitation

Passive diffusion OTHER

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

Passive diffusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient is registered in a Family Medicine Group;
• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Fonds de la Recherche en Santé du Québec: lead
• Université de Montréal: collaborator

Study Sites (1)

Centre de santé et de services sociaux de Laval

Laval, Quebec, H7M 3L9, Canada

Location

Related Publications (8)

• 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.

  PMID: 11816692 BACKGROUND

• 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.

  PMID: 20180826 BACKGROUND

• 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.

  PMID: 16951300 BACKGROUND

• 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.

  PMID: 19812802 BACKGROUND

• 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.

  PMID: 20485689 BACKGROUND

• 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.

  PMID: 17510108 BACKGROUND

• 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.

  PMID: 22379187 BACKGROUND

• 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.

  PMID: 26770705 BACKGROUND

Related Links

• Protocole de suivi interprofessionnel TRANSIT et outils cliniques associés (in French only)

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension; Dyslipidemias; Cooperative Behavior

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Social Behavior; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (professeur agrégé)

Study Record Dates

• First Submitted: August 16, 2011
• First Posted: August 17, 2011
• Study Start: April 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2016
• Last Updated: February 17, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)