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

Study 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.

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

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

Intervention / Treatment
-----------------
* Device: Assessment of Burden of Chronic Conditions (ABCC)-tool


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic clustered quasi-experimental study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABCC-tool<br>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. | Device: Assessment of Burden of Chronic Conditions (ABCC)-tool<br>* 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.<br>|
| No Intervention: Usual care<br>The control group will receive usual care, and healthcare providers will not be instructed | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived quality of care (PACIC): Patient Assessment of Chronic Illness Care | 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. | 0 months (baseline), 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived quality of care (PACIC): Patient Assessment of Chronic Illness Care | Measured with the Patient Assessment of Chronic Illness Care, for total group and for each condition separately. 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. | 0 months (baseline), 6 months, 12 months | 
| Perceived quality of care (PACIC): Patient Assessment of Chronic Illness Care | Measured with the Patient Assessment of Chronic Illness Care, for each condition separately. 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. | 0 months (baseline), 18 months | 
| Quality of life (EQ-5D-5L) | Measured with the EuroQol-5D-5L, for total group and for each condition separately. The scale consists of the EQ-5D-5L descriptive system with 5 questions, and a VAS-scale. Answers range from 1 (best) to 5 (worst). EQ-5D-5L health states, defined by the EQ-5D-5L descriptive system, will be converted into a single index value (Dutch values). The EQ-5D-5L VAS will also be determined. | 0 months (baseline), 6 months, 12 months, 18 months | 
| Capability well-being (ICECAP-A) | Measured with the ICEpop CAPability measure for Adults, for total group and for each condition separately. The questionnaire consists of 5 questions. Answers range from 1 (no capability) to 4 (full capability for an attribute). A tariff value for an overall state can be calculated by summing the values across the individual attributes. This code will allow calculation of ICECAP-A tariffs for each respondent in a study | 0 months (baseline), 6 months, 12 months, 18 months | 
| Patients' activation (PAM) | Measured with the Patient Activation Measure, for total group and for each condition separately. The questionnaire consists of 13 questions on a 5-point scale. The scores range from 0 to 100. The higher the score, the more capable a person is in self-management. | 0 months (baseline), 6 months, 12 months, 18 months | 
| Medical Consumption within Health Care | Measured with the Medical Consumption Questionnaire (MCQ), for total group and for each condition separately. The questionnaire includes 16 questions related to frequently occurring contacts with health care providers. The items will be valued using standard cost prices in the Netherlands. The costs of medical consumption are calculated by multiplying the volumes of care by the cost per unit of care. This will be used for a cost-effectiveness analysis. | 0 (baseline), 3, 6, 9, 12, 15 and 18 months | 
| Productivity losses | Measured with the Productivity Costs Questionnaire (PCQ), for total group and for each condition separately. The questionnaire includes 9 questions related to the impact of disease on the ability of a person to perform work. The items will be valued using standard cost prices in the Netherlands. Productivity lossess are calculated by multiplying the volumes by cost prices per unit. This will be used for a cost-effectiveness analysis. | 0 (baseline), 3, 6, 9, 12, 15 and 18 months |