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临床试验/NCT04127383
NCT04127383已完成不适用

Effectiveness, Cost-effectiveness and Implementation of the Assessment of Burden of Chronic Conditions (ABCC)-Tool in Patients With COPD, Asthma, Diabetes Mellitus Type 2 and Heart Failure: a Pragmatic Clustered Quasi-experimental Study

Maastricht University1 个研究点 分布在 1 个国家目标入组 237 人开始时间: 2019年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
237
试验地点
1
主要终点
Perceived quality of care (PACIC): Patient Assessment of Chronic Illness Care

研究概览

简要总结

This study is designed to evaluate the effectiveness and implementation of the Assessment of Burden of Chronic Conditions (ABCC)-tool for patients with COPD, asthma, diabetes mellitus type 2 or heart failure (and any combination of these conditions) in real-life routine practice. The ABCC-tool consists of a questionnaire, a visualisation using balloons that is based on cut-off points, and treatment advice. The ABCC-tool is intended to be used in daily healthcare practice, is designed to monitor a patient's integrated health status over time, to facilitate shared decision making, and to stimulate self-management. The study has a pragmatic clustered quasi-experimental design with two arms. The intervention group will use the ABCC-tool and the control group will receive usual care. The study will be implemented at a general practice-level, and has a follow-up period of 18 months. The primary outcome is change in perceived quality of care, as measured with the Patient Assessment of Chronic Illness Care (PACIC), as compared to usual care after 18 months. It is hypothesized that the change in perceived quality of care is significantly higher in the group using the ABCC-tool as compared to the group that receives usual care. Additionally the implementation of the ABCC-tool in general practices will be evaluated in 12 general practices. The implementation study will evaluate the context of caregivers with the Consolidated Framework for Implementation Research, the process of implementation with the RE-AIM framework, and fidelity to the intervention with the fidelity framework.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Blinding of healthcare providers and patients is not possible due to the nature of the intervention, but the study team will be blind to treatment arms in the data set during data cleaning, handling of missing data, statistical analyses and drawing of conclusions.

入排标准

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

入选标准

  • •diagnosis COPD, asthma, Diabetes Mellitus type 2 and/or heart failure
  • •can understand and read the Dutch language

排除标准

  • •COPD or asthma: used prednisone due to an exacerbation less than six weeks ago
  • •Heart failure or diabetes mellitus type 2: hospitalized less than six weeks ago
  • •Healthcare providers or patients who have already used the Assessment of Burden of COPD-tool are excluded from the control group
  • •Patients who have already used the Assessment of Burden of COPD-tool will be excluded from the intervention group

研究组 & 干预措施

ABCC-tool

Experimental

The intervention group will use the ABCC-tool during consultation with their healthcare provider. Healthcare providers in the intervention group will receive a short instructional film about the ABCC-tool before the start of the study. Additionally, healthcare providers from 12 practices will be invited for interviews, evaluating the context and process of implementation.

干预措施: Assessment of Burden of Chronic Conditions (ABCC)-tool (Device)

Usual care

No Intervention

The control group will receive usual care, and healthcare providers will not be instructed

结局指标

主要结局

Perceived quality of care (PACIC): Patient Assessment of Chronic Illness Care

时间窗: 0 months (baseline), 18 months

Measured with the Patient Assessment of Chronic Illness Care, for total group. The scale has 20 items. Answers range from 1 to 5. Average scores (range 1-5) will be calculated. Higher scores mean more frequent presence of the aspect of structured chronic care.

次要结局

  • Perceived quality of care (PACIC): Patient Assessment of Chronic Illness Care(0 months (baseline), 18 months)
  • Quality of life (EQ-5D-5L)(0 months (baseline), 6 months, 12 months, 18 months)
  • Capability well-being (ICECAP-A)(0 months (baseline), 6 months, 12 months, 18 months)
  • Patients' activation (PAM)(0 months (baseline), 6 months, 12 months, 18 months)
  • Medical Consumption within Health Care(0 (baseline), 3, 6, 9, 12, 15 and 18 months)
  • Productivity losses(0 (baseline), 3, 6, 9, 12, 15 and 18 months)
  • Perceived quality of care (PACIC): Patient Assessment of Chronic Illness Care(0 months (baseline), 6 months, 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Esther Boudewijns

Principal investigator

Maastricht University

研究点 (1)

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