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Medizinische Fakultät Effectiveness of the Assessment of Burden of COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled trial in primary and hospital care Prof. Dr. Daniel Kotz 24 March 2017 Heinrich-Heine-University Düsseldorf, Institute of General Practice, Centre for Addiction Research and Clinical Epidemiology Maastricht University | University College London | University of Edinburgh www.daniel-kotz.de

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Page 1: Medizinische Fakultät Effectiveness of the Assessment of ...Mar 24, 2017  · COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled

Medizinische Fakultät

Effectiveness of the Assessment of Burden of COPD (ABC) tool on health-related quality of life

in patients with COPD: a cluster randomised controlled trial in primary and hospital care

Prof. Dr. Daniel Kotz 24 March 2017

Heinrich-Heine-University Düsseldorf, Institute of General Practice,

Centre for Addiction Research and Clinical Epidemiology

Maastricht University | University College London | University of Edinburgh

www.daniel-kotz.de

Page 2: Medizinische Fakultät Effectiveness of the Assessment of ...Mar 24, 2017  · COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled

Medizinische Fakultät

DEBRA symposium 30 June 2017 Theme: tobacco smoking and e-cigarette use in Germany: findings from a new national survey (DEBRA) in an international perspective. Düsseldorf, 30 June 2017, 12.00-16.30h Keynote lecture: Prof. Robert West, University College London Free registration: www.debra-study.info

Page 3: Medizinische Fakultät Effectiveness of the Assessment of ...Mar 24, 2017  · COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled

Medizinische Fakultät

Disclosures

Funding sources for presented work

Lung Alliance Netherlands (www.longalliantie.nl)

Industry funding to the investigator in the last 5 years

None

Page 4: Medizinische Fakultät Effectiveness of the Assessment of ...Mar 24, 2017  · COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled

Medizinische Fakultät

COPD

• COPD affects millions of people worldwide, having major impact on daily life

• COPD is more than airway limitation (FEV1)

burden of COPD as experienced by the patient

• how to measure this burden and treat accordingly ("control panel" for physicians)?

[Agusti, Thorax 2013; GOLD 2017]

Page 5: Medizinische Fakultät Effectiveness of the Assessment of ...Mar 24, 2017  · COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled

Medizinische Fakultät

Assessment of Burden of COPD (ABC) tool

• quantification and visualisation of the burden of COPD, thereby

• facilitating the integrated approach crucial for assessment and individualised treatment of COPD

Page 6: Medizinische Fakultät Effectiveness of the Assessment of ...Mar 24, 2017  · COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled

Medizinische Fakultät

ABC tool: development

1. definition of burden Burden of disease is the physical, emotional, psychological and/or social experiences of a patient with COPD. These experiences influence the patient's ability to cope with the consequences of COPD and its treatment.

2. face validity check (patients, healthcare providers)

[Slok, Npj Primary Care Resp Med 2014]

Page 7: Medizinische Fakultät Effectiveness of the Assessment of ...Mar 24, 2017  · COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled

Medizinische Fakultät

ABC tool: development 3. condition a

burden of COPD tool should meet

4. literature review > Clinical COPD Questionnaire (CCQ) comes close [Van der Molen, Health Qual Life Outcomes 2003]

[Slok, Npj Primary Care Resp Med 2014]

Page 8: Medizinische Fakultät Effectiveness of the Assessment of ...Mar 24, 2017  · COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled

Medizinische Fakultät

ABC tool: development

5. development ABC scale = CCQ - symptoms - functional state - mental state + 3 items to measure emotions + 1 item to measure fatigue

[Slok, Npj Primary Care Resp Med 2014]

Page 9: Medizinische Fakultät Effectiveness of the Assessment of ...Mar 24, 2017  · COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled

Medizinische Fakultät

Page 10: Medizinische Fakultät Effectiveness of the Assessment of ...Mar 24, 2017  · COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled

Medizinische Fakultät

ABC tool: development

6. development ABC tool = ABC scale + objective parameters - smoking - exacerbations - dyspnoea (MRC) - body mass index - lung function - physical activity > computer algorithm > visualisation (treatment advice)

[Slok, Npj Primary Care Resp Med 2014]

Page 11: Medizinische Fakultät Effectiveness of the Assessment of ...Mar 24, 2017  · COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled

Medizinische Fakultät

Page 12: Medizinische Fakultät Effectiveness of the Assessment of ...Mar 24, 2017  · COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled

Medizinische Fakultät

ABC tool: rationale

• ABC tool = basis for shared decision making

• to support personalised care planning, including a personal treatment goal

• treatment goals often include lifestyle changes

• ABC tool = communication tool in primary and hospital care

Page 13: Medizinische Fakultät Effectiveness of the Assessment of ...Mar 24, 2017  · COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled

Medizinische Fakultät

Aim current study

Assess effectiveness in pragmatic study:

P patients with COPD

I use of ABC tool

C care as usual

O disease-specific quality of life based St. George’s Resp. Questionnaire (SGRQ) over 18 months

Page 14: Medizinische Fakultät Effectiveness of the Assessment of ...Mar 24, 2017  · COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled

Medizinische Fakultät

Netherlands Trial Register, NTR3788

Page 15: Medizinische Fakultät Effectiveness of the Assessment of ...Mar 24, 2017  · COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled

Medizinische Fakultät

Trial design

• pragmatic, two-armed, cluster randomised controlled trial

• 56 healthcare centres across the Netherlands

– 39 primary care

– 17 hospital care

• March 2013 to May 2015

Page 16: Medizinische Fakultät Effectiveness of the Assessment of ...Mar 24, 2017  · COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled

Medizinische Fakultät

Patient in/exclusion criteria

• spirometry-confirmed diagnosis

• 40 years of age or over

• understand and read the Dutch language

• exacerbation <6 weeks before study

• addiction to hard drugs

• life-threatening comorbid condition or pregnancy

Page 17: Medizinische Fakultät Effectiveness of the Assessment of ...Mar 24, 2017  · COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled

Medizinische Fakultät

Intervention vs. control

Intervention: instruction healthcare providers to use ABC tool during routine consultations (min. every 6 months)

Control: care as usual (Dutch COPD healthcare guidelines)

Page 18: Medizinische Fakultät Effectiveness of the Assessment of ...Mar 24, 2017  · COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled

Medizinische Fakultät

Outcomes

Primary: clinically relevant improvement on the SGRQ = decrease of at least 4 points on the total score of the SGRQ between baseline and the 18-month follow-up

Secondary: (amongst others)

• COPD Assessment Test (CAT)

• Patient Assessment of Chronic Illness Care (PACIC)

Page 19: Medizinische Fakultät Effectiveness of the Assessment of ...Mar 24, 2017  · COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled

Medizinische Fakultät

Page 20: Medizinische Fakultät Effectiveness of the Assessment of ...Mar 24, 2017  · COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled

Medizinische Fakultät

Slok, BMJ Open 2016

Page 21: Medizinische Fakultät Effectiveness of the Assessment of ...Mar 24, 2017  · COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled

Medizinische Fakultät

Slok, BMJ Open 2016

Page 22: Medizinische Fakultät Effectiveness of the Assessment of ...Mar 24, 2017  · COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled

Medizinische Fakultät Slok, BMJ Open 2016

Page 23: Medizinische Fakultät Effectiveness of the Assessment of ...Mar 24, 2017  · COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled

Medizinische Fakultät

Secondary outcomes

CAT not significant difference: −0.26 points (95%CI: −1.52 to 0.99)

PACIC

higher improvement in intervention group:

0.32 points (95%CI: 0.14 to 0.50)

Page 24: Medizinische Fakultät Effectiveness of the Assessment of ...Mar 24, 2017  · COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled

Medizinische Fakultät

Discussion

• ABC tool seems to have added value for patients with COPD

• patients treated with ABC tool were more likely to report clinically relevant improvement in their quality of life

• in the Netherlands: nationwide implementation in daily care ongoing

Page 25: Medizinische Fakultät Effectiveness of the Assessment of ...Mar 24, 2017  · COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled

Medizinische Fakultät

Discussion

ABC tool for Germany?

Opportunities:

• improved patient care?

Threats:

• lack of time?

• lack of communication skills?

Page 26: Medizinische Fakultät Effectiveness of the Assessment of ...Mar 24, 2017  · COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled

Medizinische Fakultät

Download today's presentation at

www.daniel-kotz.de