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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 237
- 试验地点
- 2
- 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
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)
研究者
Esther Boudewijns
Principal investigator
Maastricht University