Hypertension Clinical Trial
Official title:
Implementation of an Integrated Primary Care Network for Prevention and Management of Cardiometabolic Risks (RCM)
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04591808 -
Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia
|
Phase 3 | |
Recruiting |
NCT04515303 -
Digital Intervention Participation in DASH
|
||
Completed |
NCT05433233 -
Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension
|
N/A | |
Completed |
NCT05491642 -
A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses
|
Phase 1 | |
Completed |
NCT03093532 -
A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT05529147 -
The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
|
||
Recruiting |
NCT06363097 -
Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
|
||
Recruiting |
NCT05976230 -
Special Drug Use Surveillance of Entresto Tablets (Hypertension)
|
||
Completed |
NCT06008015 -
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
Recruiting |
NCT05121337 -
Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension
|
N/A | |
Withdrawn |
NCT04922424 -
Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men
|
Phase 1 | |
Active, not recruiting |
NCT05062161 -
Sleep Duration and Blood Pressure During Sleep
|
N/A | |
Completed |
NCT05087290 -
LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
|
||
Not yet recruiting |
NCT05038774 -
Educational Intervention for Hypertension Management
|
N/A | |
Completed |
NCT05621694 -
Exploring Oxytocin Response to Meditative Movement
|
N/A | |
Completed |
NCT05688917 -
Green Coffee Effect on Metabolic Syndrome
|
N/A | |
Recruiting |
NCT05575453 -
OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure
|
N/A |