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Clinical Trials/NCT04127383
NCT04127383
Completed
Not Applicable

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

Maastricht University1 site in 1 country237 target enrollmentNovember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Maastricht University
Enrollment
237
Locations
1
Primary Endpoint
Perceived quality of care (PACIC): Patient Assessment of Chronic Illness Care
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2019
End Date
November 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Esther Boudewijns

Principal investigator

Maastricht University

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

Outcomes

Primary Outcomes

Perceived quality of care (PACIC): Patient Assessment of Chronic Illness Care

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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