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

Maastricht University

Status: Completed

Conditions: Asthma; Chronic Obstructive Pulmonary Disease; Heart Failure; Diabetes Mellitus, Type 2

Treatments: Device: Assessment of Burden of Chronic Conditions (ABCC)-tool

Study type: Interventional

Funder types: Other

Identifiers

NCT04127383

10-10400-98-001

Details and patient eligibility

About

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.

Enrollment: 237 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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237 participants in 2 patient groups

ABCC-tool

Experimental group

Description:

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.

Treatment:

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

Usual care

No Intervention group

Description:

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