RECODE, cluster Randomized clinical trial on Effectiveness of integrated COPD management in primary carE

COPD is a worldwide growing healthcare problem, which according to the World
Health Organization will be the third leading cause of death by 2020. Given the
rise in prevalence and complex treatment, COPD also constitutes an important
financial burden that confronts health care providers with increasing treatment
capacity shortages. The most effective treatment of COPD is, besides smoking
cessation,
pulmonary rehabilitation, of which elements can be implemented successfully in
primary care setting. Pulmonary rehabilitation consists of an integrated,
multidisciplinary treatment of COPD. Beneficial effects are well established in
severe to very severe patients and significant improvements in exercise
capacity, dyspnoea and health-related quality of life have been
reported.Pulmonary rehabilitation relieves dyspnea and fatigue, improves
emotional function and enhances patients' control over their condition.
However, it is a costly intervention, is mainly applied in secondary and
tertiary care, and progressively leads to healthcare capacity shortages. In
addition, patients are not intrinsically motivated to continue a more active
and healthy lifestyle after treatment, as is it is organized in secondary and
tertiary care, mostly during only limited periods of time. In past few years,
elements of pulmonary rehabilitation like physiotherapeutic reactivation,
patient education, exacerbation management, assisted smoking cessation and
selfmanagement have been applied in primary care COPD management programmes,
which are also accessible for mild to moderate patients. Encouraging results
have been reported for patients with less advanced COPD: one-year clinically
relevant improvements of exercise tolerance, dyspnea and disease-specific
quality of life.
In conclusion, especially the highly prevalent early stages of GOLD I and II,
together representing approximately 80% of the Dutch COPD-population, are
eligible for such primary care interventions. The largest expected changes in
care will be achieved in shifting the current over prescription of inhaled
steroids (according to the Dutch NHG COPD Guideline only indicated in <20% of
the primary care COPD-population in the Netherlands) towards structural
application of important non-medical interventions. These interventions include
smoking cessation, reactivation and selfmanagement, supported by symptom-driven
bronchodilator therapy. COPD-care constitutes an increasingly important topic
in Dutch primary healthcare, driven by a large-scale shift of secondary and
tertiary care towards treatment in primary care. In the majority of cases
effective interventions are possible, but a proper evidence-base of
cost-effectiveness is currently lacking.
In conclusion, favorable long-term effects on exercise tolerance and quality of
life have been demonstrated, but wide introduction in the Dutch primary care
setting still needs further justification in the form of a proper
cost-effectiveness analysis.

RECODE aims to assess the (cost) effectiveness of an ICT-supported, integrated,
multidisciplinary two-year treatment of COPD in primary care as compared to
usual care.

This study will be structured according to a two-group cluster-randomized
design. Participating general practices will be divided in strata according to
the characteristics both of the practice and of the GPs (age, gender, practice
population size, practice situation, percentage ethnic minorities). Within
these strata, practices will be randomized (by computer), either to the
intervention group or to the control group. Randomization will be done after
base line measurements have taken place. The effects of the 2-day course and
the consecutive feedback and support, using the full application and the
refresher course after one year will be measured versus usual care. The primary
endpoint has been chosen at 12 months, while the total study duration provides
two years of follow-up.

The intervention consists of the aforementioned multidisciplinary course,
clinical and logistical feedback and support of implementation of an ICT-based
web application. During this course, Dutch primary teams will be trained during
a multidisciplinary (general practitioners, practice assistants, specialized
physiotherapists) 2-day course. This course will emphasize on efficient task
delegation within the team, active involvement of the patient in treatment
planning and designing time-contingent practice plans to improve COPD
management. The accrediting course was developed according to the recent
national NHG Guidelines, and is provided by experienced teachers who have taken
part in the development of NHG Guidelines. This course was fine-tuned
successfully in the South and West of the Netherlands during the past four
years. The intervention will be provided with a flexible web-based disease
management application. This application has been tested extensively by
end-users in the past year and is named Zorgdraad (www.zorgdraad.nl). Zorgdraad
is essentially an optimally secured electronic patient file, accessible for
patients and authorized healthcare providers. It is available free of cost for
course participants and their patients. The application stimulates
selfmanagement by patients, generates automated feedback on correct use of
guidelines, and provides clinically relevant indicators to promote structural
application of a chronic care optimalisation model. The application will
continuously generate automated feedback and regular tailored benchmark
reports. An additional refresher course will be offered after one year. Control
primary care teams will not receive the 2-day course, nor the consecutive
feedback from the Zorgdraad application.

Patients: At 0, 6, 9, 12, 18, and 24 months research nurses will deploy a
45-minute questionnaire package in all patients including the abovementioned
questionnaires.
At 0, 6 and 12 months these will be scheduled individually with patients, while
at 9, 18 and 24 months these measurements will be postal. Besides paper
versions of the questionnaire, we will provide electronic versions of the
questionnaires, which can be deployed depending on the preference of a patient.
In the intervention group, patients will receive access to a flexible web-based
application which will provide them education and space for personal notes,
which can be used according to ones personal preferences. In addition, the
research nurses will extract data regarding lung-function measurements,
exacerbations, pulmonary medication use, hospital admissions, current smoking
behavior and 6MWD results from practice patient files at 0, 6, and 12 months,
taking approximately one-hour per patient each time.

For health care providers, the multidisciplinary course will take 2 days and
0,5 day refresher course after one year. Implementation of ICT in their primary
practice will take one day.

There are no risks of participation. Treatment options all fall within current
guidelines.

Implementation of the integrated care program leads to improved exacerbation
management in practice and more efficient task delegation within the treatment
team. Enthusiasm among health care providers will rise, as outcomes at patient
level improve measurably. We expect healthcare workers participating in this
educational program to improve communication between different workers, better
adherence to guidelines, and by those means improve the quality of care.