Protocol for Regional Implementation of Community-based Collaborative Management of Complex Chronic Patients (CCP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- Reduction of early hospital-related events after hospital discharge
研究概览
简要总结
Background/Aims: Large scale adoption of integrated care for chronic patients constitutes a key milestone to accelerate adaptation of current healthcare systems to the evolving needs triggered by population ageing and high prevalence of chronic conditions. Lessons learnt from deployment experiences are being disseminated as "good practices". But, there is need for further assessment of implementation strategies in real world scenarios. Moreover, progresses achieved in disease-oriented integrated care cannot be automatically transferred to management of complex chronic patients (CCP). The protocol addresses five aims: 1) implementation of two integrated care interventions using a collaborative and adaptive case management (ACM) approach (i) Community-based management of CCP; and, ii) Integrated care for patients under long-term oxygen therapy (LTOT)); 2) adoption of information and communication technologies (ICT) required to support collaborative ACM; 3) to evaluate the impact of enhanced clinical health risk assessment and stratification; 5) to generate a roadmap for regional adoption of the CCP program.
Methods/Design: the CCP program will be deployed in three healthcare sector of Barcelona-Esquerra (AISBE) (520 k citizens) and in two other areas of Catalonia: Badalona Serveis Assistencials (BSA) (420 k citizens) and Lleida (366 k citizens) following Plan-Do-Study-Act iterative cycles, using the Model for Assessment of Telemedicine for evaluation purposes. The study also addresses the steps for scale-up of integrated care in the entire Catalan region (7.5 M citizens). Observational studies with matched controls have been planned for both Community-based management of CCP (n=3.000) and for Integrated care for patients under LTOT (n=500). Moreover, clustered randomized controlled trials (RCT) are planned on top of the observational studies to test specific questions (i.e. performance of the ICT platform providing ACM functionalities). Main components of CCP program are: a) patient stratification; b) comprehensive assessment strategies; c) ICT supported adaptive Case management; d) Roadmap for regional adoption.
Hypothesis: the CCP program will generate guidelines for large scale deployment of the CCP program, including transferability analysis, facilitating adoption of integrated care services for management of multi-morbidity.
详细描述
Rationale & hypothesis - Both, management of multi-morbidity and efficient collaboration between specialized care and community-based services are unmet needs that can be overcome by implementation of structured, but flexible, service workflows. That is, an ACM approach, as well as appropriate patient health risks assessment and stratification.
The service workflow has two sequential phases with specific target outcomes for each of them: i) Short-term (30 and 90 days after hospital discharge) prevention of hospital-related events after hospital discharge; and ii) Intervention aiming at long-term enhanced CCP management.
Objectives - To assess the impact of ICT-supported ACM on: i) reduction of early hospital-related events including hospital re-admissions, visits to emergency department and mortality; and, ii) Health value generation of the long-term intervention, defined as target outcomes achieved relative to their costs.Detailed outcomes include the eleven indicators recommended by the Spanish Health System covering the following dimensions: i) Characteristics of the study groups and health status (i.e, Users attended in primary care and, Health-related quality of life of patients and caregivers); ii) Intermediate outcomes (Emergency Department visits; General Practitioner visits; Cumulative days per year admitted in hospital; Poli-medication; Potentially avoidable hospitalizations; Hospital readmissions; Needs for social support); iii) Empowerment (Unhealthy life styles); and, iv) Structure (Access to ICT-supported integrated care). Moreover, through the program lifespan progresses consolidated by the International Consortium for Health Outcomes Measurement (ICHOM) will be incorporated.
Study design - The large-scale deployment will be evaluated as an observational study with a matched control group. Assessment will be done by an independent team. The number of patients to be included in the implementation study is approximately one-thousand individuals per year, including both conventional hospitalization and home hospitalization as recruitment sources.
Intervention - The general structure of the service workflow for the intervention group is as follows:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patients and LACE index ≥7.
排除标准
- •Severe psychiatric disorders
结局指标
主要结局
Reduction of early hospital-related events after hospital discharge
时间窗: 30 and 90 days and 12 months
Hospital re-admissions
次要结局
未报告次要终点
研究者
Carme Hernandez
Director Integrated Care Unit
Hospital Clinic of Barcelona