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Behavioral Intervention

Chronic care management 1 for High Blood Pressure (RCM Trial)

N/A
Waitlist Available
Led By Pierre Tousignant, MD
Research Sponsored by Public Health Department, Montreal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months after registration
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • High Blood Pressure
  • Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months after registration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months after registration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Diabetes and Hypertension control
Secondary study objectives
Effects on follow-up of chronic diseases
Effects on patient's autonomy
Effects on patient's behavior
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups
Active Control
Group I: Chronic care management 1Active Control1 Intervention
Content of chronic care model implemented in territory 1 and level of implementation
Group II: Chronic care management 5Active Control1 Intervention
Content of chronic care model implemented in territory 5 and level of implementation
Group III: Chronic care management 3Active Control1 Intervention
Content of chronic care model implemented in territory 3 and level of implementation
Group IV: Chronic care management 2Active Control1 Intervention
Content of chronic care model implemented in territory 2 and level of implementation
Group V: Chronic care management 6Active Control1 Intervention
Content of chronic care model implemented in territory 6 and level of implementation
Group VI: Chronic care management 4Active Control1 Intervention
Content of chronic care model implemented in territory 4 and level of implementation

Find a Location

Who is running the clinical trial?

Ministere de la Sante et des Services SociauxOTHER
17 Previous Clinical Trials
75,133 Total Patients Enrolled
Fonds de la Recherche en Santé du QuébecOTHER_GOV
82 Previous Clinical Trials
43,581 Total Patients Enrolled
Health and Social Services Agency, MontrealOTHER
1 Previous Clinical Trials
455 Total Patients Enrolled
~206 spots leftby Nov 2025