CClinicalTrials.gg
Status unknownNCT01326130RCMUpdated Mar 30, 2011

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

An interventional study of Chronic care management 1-6 in Diabetes and Hypertension, sponsored by Public Health Department, Montreal. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-03-30.

Sponsored by Public Health Department, Montreal · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2011), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
3,000
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Diabetes
  • Hypertension

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Keywords

  • Integrated care network
  • Chronic care model
  • Health services research
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

This is the only study on the registry with Public Health Department, Montreal as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
3,000 participants (estimated)

Study arms

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Interventions

  • BehavioralChronic 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.

06

What researchers measure

Primary outcomes

  1. Diabetes and Hypertension control

    Biomedical indicators of diabetes (Hb A1c ≤7%) and hypertension (blood pressure ≤ 140/90) control

    Time frame: 24 months after registration

Secondary outcomes

  1. Effects on patient's behavior

    Life-style improvement (physical activity, nutrition, smoking)

    Time frame: 24 months after registration

  2. Effects on patient's autonomy

    Self-care

    Time frame: 24 months after registration

  3. Effects on patient's health

    Quality of live

    Time frame: 24 months after registration

  4. Effects on follow-up of chronic diseases

    Chronic care management

    Time frame: 24 months after registration

  5. Effects on process of care

    Indexes of continuity, accessibility, comprehensiveness and perceived quality of care

    Time frame: 24 months after registration

  6. Effects on physician practice

    Physician perception regarding effects of program on patients, inter-professional collaboration, development of knowledge, management of diabetes and hypertension

    Time frame: 24 months after registration

07

Study locations

1 site
  • Public Health Department
    Montreal, Quebec H2L 1M3, Canada
08

References and documents

Publications

  • Provost S, Pineault R, Tousignant P, Hamel M, Da Silva RB. Evaluation of the implementation of an integrated primary care network for prevention and management of cardiometabolic risk in Montreal. BMC Fam Pract. 2011 Nov 10;12:126. doi: 10.1186/1471-2296-12-126. PubMed 22074614 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01326130
Lead sponsor
Public Health Department, Montreal
Collaborators
Health and Social Services Agency, Montreal, Fonds de la Recherche en Santé du Québec, Ministere de la Sante et des Services Sociaux
First posted
Mar 30, 2011
Start date
Apr 2011
Primary completion
Jun 2014 (estimated)
Completion
Jun 2014 (estimated)
Last update
Mar 30, 2011

Study contacts

Pierre Tousignant Tousignant, MD
Contact
ptousi@santepub-mtl.qc.ca
514-528-2400 ext. 3569
Raynald Pineault, Md
Contact
rpineaul@santepub-mt.qc.ca
514-528-2400 ext. 3480
Pierre Tousignant, MD
principal investigator · Public Health Department, Montreal

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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