- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01326130
Implementation of an Integrated Primary Care Network for Prevention and Management of Cardiometabolic Risks (RCM)
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Pierre Tousignant Tousignant, MD
- Numero di telefono: 3569 514-528-2400
- Email: ptousi@santepub-mtl.qc.ca
Backup dei contatti dello studio
- Nome: Raynald Pineault, Md
- Numero di telefono: 3480 514-528-2400
- Email: rpineaul@santepub-mt.qc.ca
Luoghi di studio
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Quebec
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Montreal, Quebec, Canada, H2L 1M3
- Public Health Department
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Contatto:
- Pierre Tousignant, MD
- Numero di telefono: 3569 514-528-2400
- Email: ptousi@santepub-mtl.qc.ca
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Investigatore principale:
- Pierre Tousignant, MD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore attivo: Chronic care management 1
Content of chronic care model implemented in territory 1 and level of implementation
|
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.
|
Comparatore attivo: Chronic care management 2
Content of chronic care model implemented in territory 2 and level of implementation
|
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.
|
Comparatore attivo: Chronic care management 3
Content of chronic care model implemented in territory 3 and level of implementation
|
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.
|
Comparatore attivo: Chronic care management 4
Content of chronic care model implemented in territory 4 and level of implementation
|
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.
|
Comparatore attivo: Chronic care management 5
Content of chronic care model implemented in territory 5 and level of implementation
|
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.
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Comparatore attivo: Chronic care management 6
Content of chronic care model implemented in territory 6 and level of implementation
|
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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Diabetes and Hypertension control
Lasso di tempo: 24 months after registration
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Biomedical indicators of diabetes (Hb A1c ≤7%) and hypertension (blood pressure ≤ 140/90) control
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24 months after registration
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Effects on patient's behavior
Lasso di tempo: 24 months after registration
|
Life-style improvement (physical activity, nutrition, smoking)
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24 months after registration
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Effects on patient's autonomy
Lasso di tempo: 24 months after registration
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Self-care
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24 months after registration
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Effects on patient's health
Lasso di tempo: 24 months after registration
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Quality of live
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24 months after registration
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Effects on follow-up of chronic diseases
Lasso di tempo: 24 months after registration
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Chronic care management
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24 months after registration
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Effects on process of care
Lasso di tempo: 24 months after registration
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Indexes of continuity, accessibility, comprehensiveness and perceived quality of care
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24 months after registration
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Effects on physician practice
Lasso di tempo: 24 months after registration
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Physician perception regarding effects of program on patients, inter-professional collaboration, development of knowledge, management of diabetes and hypertension
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24 months after registration
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Pierre Tousignant, MD, Public Health Department, Montreal
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- RisqueCardioMetabolique
- FRSQ 22425 (Altro identificatore: Fonds de la recherche en santé du Québec)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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