Clinical trial NCT04127383: Effectiveness and Implementation of the Assessment of Burden of Chronic Conditions (ABCC)-Tool
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Asthma
Diabetes Mellitus, Type 2
Heart Failure
Lead sponsor: Maastricht University
Sponsor class: OTHER
Collaborators: name: Netherlands Instititute for Health Services Research
name: TNO
name: University of Twente
First posted: 2019-10-15
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic clustered quasi-experimental study
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Perceived quality of care (PACIC): Patient Assessment of Chronic Illness Care
timeFrame: 0 months (baseline), 18 months
Secondary outcomes:
measure: Perceived quality of care (PACIC): Patient Assessment of Chronic Illness Care
timeFrame: 0 months (baseline), 6 months, 12 months
measure: Perceived quality of care (PACIC): Patient Assessment of Chronic Illness Care
timeFrame: 0 months (baseline), 18 months
measure: Quality of life (EQ-5D-5L)
timeFrame: 0 months (baseline), 6 months, 12 months, 18 months
measure: Capability well-being (ICECAP-A)
timeFrame: 0 months (baseline), 6 months, 12 months, 18 months
measure: Patients' activation (PAM)
timeFrame: 0 months (baseline), 6 months, 12 months, 18 months
measure: Medical Consumption within Health Care
timeFrame: 0 (baseline), 3, 6, 9, 12, 15 and 18 months
measure: Productivity losses
timeFrame: 0 (baseline), 3, 6, 9, 12, 15 and 18 months
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
affiliation: Maastricht University
name: Onno CP van Schayck, Prof.
role: STUDY_DIRECTOR
References:
citation: Boudewijns EA, Claessens D, Joore M, Keijsers LCEM, van Schayck OCP, Winkens B, Gidding-Slok AHM. Effectiveness and cost-effectiveness of the Assessment of Burden of Chronic Conditions (ABCC) tool in patients with COPD, asthma, diabetes mellitus type 2 and heart failure: protocol for a pragmatic clustered quasi-experimental study. BMJ Open. 2020 Nov 17;10(11):e037693. doi: 10.1136/bmjopen-2020-037693.