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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

237 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2022-11-01

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Pragmatic clustered quasi-experimental study

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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ABCC-tool

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.

Group Type EXPERIMENTAL

Assessment of Burden of Chronic Conditions (ABCC)-tool

Intervention Type DEVICE

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.

Usual care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No