Healt status guided COPD (March)

Chronic Obstructive Pulmonary Disease (COPD) is a disease state characterized
by airflow limitation that is not fully reversible. The airflow limitation is
usually progressive and associated with an abnormal inflammatory response of
the lungs to noxious particles or gases. COPD has a considerable impact on
health status. Impaired exercise tolerance, fatigue, muscle weakness,
depression and sleeping disorders are all features that characterize the
disease.
The treatment strategies suggested by current guidelines are based primarily on
a categorization on lung function impairment, more specifically the FEV1, while
it is well known that the FEV1 has a poor correlation with many features of
COPD, and therefore the impact the disease has on the patient. Neither symptoms
nor impact of disease on the patients wellbeing have, however, been
incorporated in treatment algorithms so far

We hypothesize that a treatment algorithm that is based on a simple validated
measure of health status (CCQ) improves quality of life (as measured on a
separate scale) and other classical COPD outcome measurement parameters such as
exacerbation frequency, patient satisfaction, and health care utilization
compared to care based on current GOLD guidelines.
The research questions addressed are:
1. Does a treatment algorithm that is based on CCQ measurements alone and
provides tailor-made patient guidance on both non-pharmaceutical and
pharmaceutical interventions described in guidelines, improve health status as
measured by SGRQ after two years of use compared to care based on guidelines?
2. Does such a treatment algorithm improve other parameters of COPD care such
as exacerbation frequency, patient satisfaction, and health care utilization
compared care based on current GOLD guidelines?

This is a prospective randomized controlled trial with two arms: (i) the
intervention group and (ii) the FEV1-guided care group. The interventiongroup
will get treatment advice bases on a treatment algorithm that is based on the
CCQ-score (health status), the controlgroup will get standard treatment advice
based on the FEV1 only (according to GOLD-guidelines).
This study will take place in the adherence area of LabNoord, which includes
all general practices in the northern part of the Netherlands. Patients will be
followed up for 2 years. There will be 4 visits per year (a total of 9 visits)


The following information will be displayed to the general practitioner for the
intevention group:
• The current CCQ score and scores on each domain of the scale (symptoms,
functional score and mental score).
• A graph of scores of previous visits where available.
• A warning appears if compared to the previous visit, the current CCQ has
changed in excess of the minimal clinically important difference of the CCQ
scale (0.4).
• The algorithm steps and treatment advice.

For the control group: The GP receives the result from the patient*s visit to
LabNoord. The feedback to the GP consists out of the FEV1 values, and the
advice to treat according to the current guidelines.

Individual treatment advice which is based on a treatment algorithm based on
the CCQ-score

No risk for the patient, only some extra visits