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临床试验/NCT03332394
NCT03332394已完成不适用

Impact of Goal-Directed COPD Care Model on Clinical and Patient-Reported Outcomes : A Pilot Feasibility Study

Ottawa Hospital Research Institute1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2017年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
1
主要终点
Feasibility of the COPD Care Pathway on a hospital ward

研究概览

简要总结

This study is the first to evaluate a unique integrated care model for COPD which uses a validated clinical frailty indicator to set care goals and guide health care in hospital and in the community. The impact of this care model on patient reported outcomes, costs, and health care utilization will inform further health system re-design for patients with COPD and other chronic diseases.

详细描述

Background: Chronic obstructive pulmonary disease (COPD) is an incurable and progressive lung disease associated with poor quality of life, increased mortality, and high health system costs. Health system care for COPD patients is often fragmented, and patients report feeling isolated and lack the confidence in health services to address their needs.

Integrated COPD care programs attempt to address the many physical, psychosocial, and medical needs of COPD patients by bridging the gaps in care between hospital and community settings. These programs are tailored to patients with severe disease and involve self-management education sessions and sustained contact with a health care provider in the community. Evidence for the efficacy of integrated care programs is conflicting and there is limited information on which COPD patients would benefit from these programs. Prior integrated care programs have used a 'one size fits all' approach to care, where all patients receive the same interventions and treatments. There is a need for a more personalized approach to COPD care, as comorbidity burden, socioeconomic factors, and functional status also have a significant influence on health outcomes in this patient population.

Hypothesis: The investigators hypothesize that care-delivery tailored to a patient's goals and functional health status will improve patient engagement, and translate into both short and long-term improved health service outcomes.

Objectives: The objectives of this study are to: 1) Determine the feasibility of implementing a unique goal-directed COPD care model in the hospital setting, and 2) Determine the process measures and personnel required for successful replication of this care model intervention in other sites

Methods: This prospective cohort study will include 50 adult patients hospitalized for COPD exacerbation between November 2017 and May 2019. The investigators will determine the clinical frailty rating for each enrolled patient. The frailty rating will be matched with pre-specified care goals, and subsequent health care consultations and services will be arranged based upon these goals. COPD burden and 'health confidence' will be measured prior to the intervention and at 3 months following discharge, and also determine cost of hospitalization, length of stay, 30-day readmission rate, and mortality. The Wilcoxon's signed-rank test will be used to compare patient reported outcomes before and after the care intervention in the study cohort. An interrupted time series analysis will be used to determine the differences in health service outcomes between the study cohort and a random sample of hospitalized COPD patients from a contemporary period one year-prior to the care intervention.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hospitalized with a COPD exacerbations between November 2017 to May 2019 on the Respiratory ward of the Ottawa Hospital, General campus
  • Healthcare professional working on the Respiratory and Medicine wards of the Ottawa Hospital, General campus who used the COPD care pathway

排除标准

  • Patients not appropriate for inclusion

结局指标

主要结局

Feasibility of the COPD Care Pathway on a hospital ward

时间窗: 6 months from patient enrollment

In this practical experiment, feasibility will be defined by recruitment of 50 patients (3-4 per month x 18 months) to the care pathway, with an 85% completion rate. This will be calculated using the number of completed pathway documents divided by the total number of care pathways initiated at the time of admission. Each document will be critically reviewed for completion.

次要结局

  • Qualitative Implementation Metrics - Identification of Barriers to the Care Pathway(March 2018)
  • Qualitative Implementation Metrics - Healthcare Worker assessment of the Care Pathway(March 2018)
  • Patient Reported 'Quality of Life'(Admission to 3 months post-discharge)
  • Health Service Metrics - Cost per weighted case(3 months post-discharge)
  • Health Service Metrics - Mortality(6 months post-discharge)
  • Patient Reported 'Health Confidence'(Hospital admission to 3 months post-discharge)
  • Health Service Metrics - Length of stay in hospital(3 months post-discharge)
  • Health Service Metrics - 30-day readmission(3 months post-discharge)
  • Knowledge Translation Metrics(November 2017 to May 2019)
  • Health Service Metrics - Intensive Care Unit Admission(3 months post-discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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