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Implementation of an Integrated Primary Care Network for Prevention and Management of Cardiometabolic Risks (RCM)

This study is not yet open for participant recruitment.
Verified March 2011 by Public Health Department, Montreal
Sponsor:
Collaborators:
Agence de la santé et des services sociaux de Montréal
Fonds de la Recherche en Santé du Québec
Ministère de santé et des services sociaux du Québec
Information provided by:
Public Health Department, Montreal
ClinicalTrials.gov Identifier:
NCT01326130
First received: March 28, 2011
Last updated: March 29, 2011
Last verified: March 2011
  Purpose

CONTEXTE: L'Agence de la santé et des services sociaux de Montréal (ASSS) invited our research team to evaluate the implementation of an integrated and interdisciplinary primary care network for prevention and management of cardiometabolic risks (diabetes and hypertension) (PCR). The intervention is based on the Chronic Care Model and the development of an integrated services network. PCR is to be implemented in 6 territories of "Centre de santé et de services sociaux (CSSS)". A first application for funding was made to Fonds Pfizer-FRSQ-MSSS for an evaluation that has to be completed in the first 24 month after the beginning of the implementation. This application to the PHSI program at CIHR is complementary and will ensure an evaluation of the sustainability of PCR and of long term effects (40 months after the beginning of the implementation) for patients and for their primary care physicians.

In each CSSS, PCR plans for : 1- an interdisciplinary team in an education center working with primary care physicians and offering to referred patients a pre-determined sequence of clinical interventions over a 2-year-period; 2- a program supporting primary care physicians (continuing education, documentation and clinical guidelines, referral system to second line of care); 3- networking between actors of "Réseau local de services (RLS)" insuring clinical information transfer required for efficient patient management.

OBJECTIVES: 1-evaluate PCR effects according to territory, time and degree of exposure (specifically benefits to registered patients and support to participating primary care physicians); 2- identify the degree of implementation of PCR in each CSSS territory and the related contextual factors; 3- examine the relationship between the effects identified, the degree of implementation of PCR and the related contextual factors; 4- assess the impact of implementing PCR on the strengthening of RLS.

METHODS: The proposed evaluation will be done through a mixed design including two complementary strategies. Using a "quasi-experiment/before-after" design, the first strategy is a quantitative approach looking at the program effects and their variation between territories. This analysis will use data from the PCR clinical database (ex.: HbA1c, BP, lifestyle) and from patient questionnaire inquiring about care experience, utilization of services, chronic care follow-up, self-management and quality of life. Around 3000 patients will be enlisted. A primary care physician questionnaire will enquire about PCR effects on their practice. Using primarily a qualitative and a case study approach, each of the 6 territories being one case, the second strategy will identify the degree of implementation of PCR and the explanatory contextual factors. This analysis with use data obtained from semi-structured interviews with program managers. The results of this analysis will be summarized in a monograph for each territory. According to the type of indicator analyzed, objective 3 will be fulfilled using linear models or longitudinal multilevel models supplemented with an interpretive approach using the information from monographs and discussion groups. The impact of implementing PCR on RLS will be assessed through interviews with key informants.

RESULTS AND EXPECTED IMPACT: Our study will identify the effectiveness of PCR and contextual factors associated with successful implementation and sustainability of PCR. Detailed contextual information will allow application of our results to other environments that have similar context and to other chronic conditions that could benefit from an integrated services network.

KNOWLEDGE TRANSFER: Since decision makers, clinicians and researchers did and will take part in all phases of PRC evaluation (planning, data collection, analysis and interpretation), diffusion of information regarding the program is an integral part of the research process. In addition, results will be presented at local, regional, provincial and national conferences and published in reports and articles widely distributed. More specifically, a regional symposium will be organized to share evaluation results with all CSSS in the region (n=12) and with all our local and regional partners.


Condition Intervention
Diabetes
Hypertension
Behavioral: Chronic care management 1-6

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Implementation of an Integrated Primary Care Network for Prevention and Management of Cardiometabolic Risks (RCM)

Resource links provided by NLM:


Further study details as provided by Public Health Department, Montreal:

Primary Outcome Measures:
  • Diabetes and Hypertension control [ Time Frame: 24 months after registration ] [ Designated as safety issue: No ]
    Biomedical indicators of diabetes (Hb A1c ≤7%) and hypertension (blood pressure ≤ 140/90) control


Secondary Outcome Measures:
  • Effects on patient's behavior [ Time Frame: 24 months after registration ] [ Designated as safety issue: No ]
    Life-style improvement (physical activity, nutrition, smoking)

  • Effects on patient's autonomy [ Time Frame: 24 months after registration ] [ Designated as safety issue: No ]
    Self-care

  • Effects on patient's health [ Time Frame: 24 months after registration ] [ Designated as safety issue: No ]
    Quality of live

  • Effects on follow-up of chronic diseases [ Time Frame: 24 months after registration ] [ Designated as safety issue: No ]
    Chronic care management

  • Effects on process of care [ Time Frame: 24 months after registration ] [ Designated as safety issue: No ]
    Indexes of continuity, accessibility, comprehensiveness and perceived quality of care

  • Effects on physician practice [ Time Frame: 24 months after registration ] [ Designated as safety issue: No ]
    Physician perception regarding effects of program on patients, inter-professional collaboration, development of knowledge, management of diabetes and hypertension


Estimated Enrollment: 3000
Study Start Date: April 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Chronic care management 1
Content of chronic care model implemented in territory 1 and level of implementation
Behavioral: Chronic care management 1-6
1- an interdisciplinary team in an education center working with primary care physicians and offering to referred patients a pre-determined sequence of clinical interventions over a 2-year-period; 2- a program supporting primary care physicians (continuing education, documentation and clinical guidelines, referral system to second line of care); 3- networking between actors insuring clinical information transfer required for efficient patient management.
Active Comparator: Chronic care management 2
Content of chronic care model implemented in territory 2 and level of implementation
Behavioral: Chronic care management 1-6
1- an interdisciplinary team in an education center working with primary care physicians and offering to referred patients a pre-determined sequence of clinical interventions over a 2-year-period; 2- a program supporting primary care physicians (continuing education, documentation and clinical guidelines, referral system to second line of care); 3- networking between actors insuring clinical information transfer required for efficient patient management.
Active Comparator: Chronic care management 3
Content of chronic care model implemented in territory 3 and level of implementation
Behavioral: Chronic care management 1-6
1- an interdisciplinary team in an education center working with primary care physicians and offering to referred patients a pre-determined sequence of clinical interventions over a 2-year-period; 2- a program supporting primary care physicians (continuing education, documentation and clinical guidelines, referral system to second line of care); 3- networking between actors insuring clinical information transfer required for efficient patient management.
Active Comparator: Chronic care management 4
Content of chronic care model implemented in territory 4 and level of implementation
Behavioral: Chronic care management 1-6
1- an interdisciplinary team in an education center working with primary care physicians and offering to referred patients a pre-determined sequence of clinical interventions over a 2-year-period; 2- a program supporting primary care physicians (continuing education, documentation and clinical guidelines, referral system to second line of care); 3- networking between actors insuring clinical information transfer required for efficient patient management.
Active Comparator: Chronic care management 5
Content of chronic care model implemented in territory 5 and level of implementation
Behavioral: Chronic care management 1-6
1- an interdisciplinary team in an education center working with primary care physicians and offering to referred patients a pre-determined sequence of clinical interventions over a 2-year-period; 2- a program supporting primary care physicians (continuing education, documentation and clinical guidelines, referral system to second line of care); 3- networking between actors insuring clinical information transfer required for efficient patient management.
Active Comparator: Chronic care management 6
Content of chronic care model implemented in territory 6 and level of implementation
Behavioral: Chronic care management 1-6
1- an interdisciplinary team in an education center working with primary care physicians and offering to referred patients a pre-determined sequence of clinical interventions over a 2-year-period; 2- a program supporting primary care physicians (continuing education, documentation and clinical guidelines, referral system to second line of care); 3- networking between actors insuring clinical information transfer required for efficient patient management.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetic adults with borderline fasting blood sugar or glucose intolerance or treated with diet only or treated with only one medication or treated with multiple medications but with Hb A1c ≤ 8%;
  • Adults with blood pressure in office ≥ 140/90 mm Hg (if diabetes present, BP ≥ 130/80 mm Hg)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01326130

Contacts
Contact: Pierre Tousignant Tousignant, MD 514-528-2400 ext 3569 ptousi@santepub-mtl.qc.ca
Contact: Raynald Pineault, Md 514-528-2400 ext 3480 rpineaul@santepub-mt.qc.ca

Locations
Canada, Quebec
Public Health Department Not yet recruiting
Montreal, Quebec, Canada, H2L 1M3
Contact: Pierre Tousignant, MD    514-528-2400 ext 3569    ptousi@santepub-mtl.qc.ca   
Principal Investigator: Pierre Tousignant, MD         
Sponsors and Collaborators
Public Health Department, Montreal
Agence de la santé et des services sociaux de Montréal
Fonds de la Recherche en Santé du Québec
Ministère de santé et des services sociaux du Québec
Investigators
Principal Investigator: Pierre Tousignant, MD Public Health Department, Montreal
  More Information

No publications provided by Public Health Department, Montreal

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pierre Tousignant, Médecin conseil, Public Health Department, Montréal
ClinicalTrials.gov Identifier: NCT01326130     History of Changes
Other Study ID Numbers: RisqueCardioMetabolique, FRSQ 22425
Study First Received: March 28, 2011
Last Updated: March 29, 2011
Health Authority: Canada: Ethics Review Committee
United States: Federal Government

Keywords provided by Public Health Department, Montreal:
Integrated care network
Chronic care model
Health services research

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014