- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Pierre Tousignant Tousignant, MD
- Telefonnummer: 3569 514-528-2400
- E-Mail: ptousi@santepub-mtl.qc.ca
Studieren Sie die Kontaktsicherung
- Name: Raynald Pineault, Md
- Telefonnummer: 3480 514-528-2400
- E-Mail: rpineaul@santepub-mt.qc.ca
Studienorte
-
-
Quebec
-
Montreal, Quebec, Kanada, H2L 1M3
- Public Health Department
-
Kontakt:
- Pierre Tousignant, MD
- Telefonnummer: 3569 514-528-2400
- E-Mail: ptousi@santepub-mtl.qc.ca
-
Hauptermittler:
- Pierre Tousignant, MD
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Aktiver Komparator: 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.
|
Aktiver Komparator: 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.
|
Aktiver Komparator: 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.
|
Aktiver Komparator: 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.
|
Aktiver Komparator: 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.
|
Aktiver Komparator: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Diabetes and Hypertension control
Zeitfenster: 24 months after registration
|
Biomedical indicators of diabetes (Hb A1c ≤7%) and hypertension (blood pressure ≤ 140/90) control
|
24 months after registration
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Effects on patient's behavior
Zeitfenster: 24 months after registration
|
Life-style improvement (physical activity, nutrition, smoking)
|
24 months after registration
|
Effects on patient's autonomy
Zeitfenster: 24 months after registration
|
Self-care
|
24 months after registration
|
Effects on patient's health
Zeitfenster: 24 months after registration
|
Quality of live
|
24 months after registration
|
Effects on follow-up of chronic diseases
Zeitfenster: 24 months after registration
|
Chronic care management
|
24 months after registration
|
Effects on process of care
Zeitfenster: 24 months after registration
|
Indexes of continuity, accessibility, comprehensiveness and perceived quality of care
|
24 months after registration
|
Effects on physician practice
Zeitfenster: 24 months after registration
|
Physician perception regarding effects of program on patients, inter-professional collaboration, development of knowledge, management of diabetes and hypertension
|
24 months after registration
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Pierre Tousignant, MD, Public Health Department, Montreal
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- RisqueCardioMetabolique
- FRSQ 22425 (Andere Kennung: Fonds de la recherche en santé du Québec)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Hypertonie
-
Nantes University HospitalBeendetZirrhotischer Patient mit Verdacht auf portale Hypertension und im Rahmen eines OV-ScreeningsFrankreich
Klinische Studien zur Chronic care management 1-6
-
Qure Healthcare, LLCAktiv, nicht rekrutierendKardiometabolisches SyndromVereinigte Staaten
-
University of AarhusTRYG Foundation; Danish Committee for Health EducationAbgeschlossenChronischer SchmerzDänemark
-
Qure Healthcare, LLCAbgeschlossenChronische Erkrankung | Medikamentenhaftung | ArzneimittelwechselwirkungVereinigte Staaten
-
University of WashingtonNational Center for Complementary and Integrative Health (NCCIH)Aktiv, nicht rekrutierendChronischer SchmerzVereinigte Staaten
-
Medical College of WisconsinNoch keine Rekrutierung
-
Medical College of WisconsinChildren's Hospital and Health System Foundation, WisconsinRekrutierungAkute lymphatische Leukämie | Akute lymphoblastische Leukämie, Pädiatrie | Akute lymphoblastische Leukämie, im Rückfall | Rezidivierende akute lymphoblastische Leukämie | Akute lymphoblastische Leukämie mit gescheiterter Remission | Akute lymphoblastische Leukämie, die keine Remission erreicht...Vereinigte Staaten
-
Xuzhou Medical UniversityRekrutierungAkute myeloische Leukämie, im Rückfall | Refraktär bei akuter myeloischer LeukämieChina
-
Beijing Boren HospitalRekrutierung
-
Kaiser PermanenteAbgeschlossenChronischer SchmerzVereinigte Staaten
-
Shenzhen Fifth People's HospitalRekrutierung