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

Primary Purpose

Diabetes, Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Chronic care management 1-6
Sponsored by
Public Health Department, Montreal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes focused on measuring Integrated care network, Chronic care model, Health services research

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Public Health Department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Chronic care management 1

Chronic care management 2

Chronic care management 3

Chronic care management 4

Chronic care management 5

Chronic care management 6

Arm Description

Content of chronic care model implemented in territory 1 and level of implementation

Content of chronic care model implemented in territory 2 and level of implementation

Content of chronic care model implemented in territory 3 and level of implementation

Content of chronic care model implemented in territory 4 and level of implementation

Content of chronic care model implemented in territory 5 and level of implementation

Content of chronic care model implemented in territory 6 and level of implementation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Effects on patient's behavior
Life-style improvement (physical activity, nutrition, smoking)
Effects on patient's autonomy
Self-care
Effects on patient's health
Quality of live
Effects on follow-up of chronic diseases
Chronic care management
Effects on process of care
Indexes of continuity, accessibility, comprehensiveness and perceived quality of care
Effects on physician practice
Physician perception regarding effects of program on patients, inter-professional collaboration, development of knowledge, management of diabetes and hypertension

Full Information

First Posted
March 28, 2011
Last Updated
March 29, 2011
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
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1. Study Identification

Unique Protocol Identification Number
NCT01326130
Brief Title
Implementation of an Integrated Primary Care Network for Prevention and Management of Cardiometabolic Risks
Acronym
RCM
Official Title
Implementation of an Integrated Primary Care Network for Prevention and Management of Cardiometabolic Risks (RCM)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the 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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Hypertension
Keywords
Integrated care network, Chronic care model, Health services research

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chronic care management 1
Arm Type
Active Comparator
Arm Description
Content of chronic care model implemented in territory 1 and level of implementation
Arm Title
Chronic care management 2
Arm Type
Active Comparator
Arm Description
Content of chronic care model implemented in territory 2 and level of implementation
Arm Title
Chronic care management 3
Arm Type
Active Comparator
Arm Description
Content of chronic care model implemented in territory 3 and level of implementation
Arm Title
Chronic care management 4
Arm Type
Active Comparator
Arm Description
Content of chronic care model implemented in territory 4 and level of implementation
Arm Title
Chronic care management 5
Arm Type
Active Comparator
Arm Description
Content of chronic care model implemented in territory 5 and level of implementation
Arm Title
Chronic care management 6
Arm Type
Active Comparator
Arm Description
Content of chronic care model implemented in territory 6 and level of implementation
Intervention Type
Behavioral
Intervention Name(s)
Chronic care management 1-6
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diabetes and Hypertension control
Description
Biomedical indicators of diabetes (Hb A1c ≤7%) and hypertension (blood pressure ≤ 140/90) control
Time Frame
24 months after registration
Secondary Outcome Measure Information:
Title
Effects on patient's behavior
Description
Life-style improvement (physical activity, nutrition, smoking)
Time Frame
24 months after registration
Title
Effects on patient's autonomy
Description
Self-care
Time Frame
24 months after registration
Title
Effects on patient's health
Description
Quality of live
Time Frame
24 months after registration
Title
Effects on follow-up of chronic diseases
Description
Chronic care management
Time Frame
24 months after registration
Title
Effects on process of care
Description
Indexes of continuity, accessibility, comprehensiveness and perceived quality of care
Time Frame
24 months after registration
Title
Effects on physician practice
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre Tousignant Tousignant, MD
Phone
514-528-2400
Ext
3569
Email
ptousi@santepub-mtl.qc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Raynald Pineault, Md
Phone
514-528-2400
Ext
3480
Email
rpineaul@santepub-mt.qc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Tousignant, MD
Organizational Affiliation
Public Health Department, Montreal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Public Health Department
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 1M3
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Tousignant, MD
Phone
514-528-2400
Ext
3569
Email
ptousi@santepub-mtl.qc.ca
First Name & Middle Initial & Last Name & Degree
Pierre Tousignant, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
22074614
Citation
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.
Results Reference
derived

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

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