NCT04127383

Effectiveness and Implementation of the Assessment of Burden of Chronic Conditions (ABCC)-Tool

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 237 (actual)
• Sponsor: Maastricht University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Obstructive Pulmonary Disease
• Asthma
• Diabetes Mellitus, Type 2
• Heart Failure

Interventions

Type	Name	Description
DEVICE	Assessment of Burden of Chronic Conditions (ABCC)-tool	The tool consists of a questionnaire, a visualisation using balloons, and treatment advice. A patient completes the questionnaire before consultation. The questionnaire measures the experienced burden of the chronic condition(s), and several risk factors. The questionnaire consists of a generic part and disease-specific parts. The generic questionnaire will be combined with any amount of disease-specific questionnaires (i.e. COPD, asthma, diabetes type 2 and heart failure), to form a single personalised scale and balloon chart for each individual patient. Outcomes of the questionnaire are visualised using balloons. The healthcare provider opens the visualisation during consultation. A balloon represents a domain, and the colour and height indicate a score on that domain. If a patient and healthcare provider select a balloon by clicking on it, treatment advice is shown by means of pop-ups. Based on the discussion following treatment advice, personal care plans can be determined.

Timeline

• Start date: 2019-11-01
• Primary completion: 2022-11-01
• Completion: 2022-11-01
• First posted: 2019-10-15
• Last updated: 2023-03-16

Locations

1 site across 1 country: Netherlands