- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Pierre Tousignant Tousignant, MD
- 전화번호: 3569 514-528-2400
- 이메일: ptousi@santepub-mtl.qc.ca
연구 연락처 백업
- 이름: Raynald Pineault, Md
- 전화번호: 3480 514-528-2400
- 이메일: rpineaul@santepub-mt.qc.ca
연구 장소
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Quebec
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Montreal, Quebec, 캐나다, H2L 1M3
- Public Health Department
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연락하다:
- Pierre Tousignant, MD
- 전화번호: 3569 514-528-2400
- 이메일: ptousi@santepub-mtl.qc.ca
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수석 연구원:
- Pierre Tousignant, MD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: Chronic care management 1
Content of chronic care model implemented in territory 1 and level of implementation
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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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활성 비교기: Chronic care management 2
Content of chronic care model implemented in territory 2 and level of implementation
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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.
|
활성 비교기: Chronic care management 3
Content of chronic care model implemented in territory 3 and level of implementation
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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.
|
활성 비교기: Chronic care management 4
Content of chronic care model implemented in territory 4 and level of implementation
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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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활성 비교기: Chronic care management 5
Content of chronic care model implemented in territory 5 and level of implementation
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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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활성 비교기: Chronic care management 6
Content of chronic care model implemented in territory 6 and level of implementation
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Diabetes and Hypertension control
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Effects on patient's behavior
기간: 24 months after registration
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Life-style improvement (physical activity, nutrition, smoking)
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24 months after registration
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Effects on patient's autonomy
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Pierre Tousignant, MD, Public Health Department, Montreal
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Chronic care management 1-6에 대한 임상 시험
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Air Liquide Santé International완전한비침습적 가정 환기를 받는 만성 호흡 부전 환자의 치료 표준과 비교하여 의료 경로 개선을 위한 원격 의료의 원격 모니터링 및 실험 평가 연구(ETAPES 프로그램) (e-VENT)만성 폐쇄성 폐질환(COPD) | 비만 저환기 증후군(OHS) | 고칼슘혈증을 동반한 만성 호흡 부전프랑스
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Zealand University HospitalUniversity of Copenhagen; Steno Diabetes Center Copenhagen; Holbaek Sygehus모병
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University of ChicagoNational Institutes of Health (NIH); University of Houston아직 모집하지 않음자가지방이식
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Composite Interceptive Med ScienceBioxytran Inc.완전한