Heart Failure clinics versus primary care in the long-term follow-up of patients with chronic heart failure; COACH-2

Multidisciplinary management programs within specialized HF clinics have proven
to be effective in terms of patient compliance, hospital readmission and
mortality. Most of the programs implemented in the Netherlands focus on
hospital based (outpatient) care, primary care by means of General
Practitioners (GP) or specialized HF nurses are involved in only a minority of
the programs in the Netherlands.
Since the prevalence of HF is still growing, it is now foreseen that the HF
clinics will become overloaded and will not be able to -after initial
management of new patients, treat and monitor all HF patients for longer time
periods. However, it is known that long term follow-up is vital since studies
have shown that the results of initial optimization of therapy and education
(guideline adherence and patient compliance) will decrease within the next
year, in case no appropriate follow-up is provided. Ideally, long term
follow-up should be incorporated within the primary health care system.
However, at this time it is unclear whether and when patients can be discharged
from the HF clinic to be further managed in primary care.

The aim of the current study is to determine whether long-term follow-up in
primary care, under the condition of initial optimization of pharmacological
and non-pharmacological treatment at the specialized HF clinic is equally
effective as long term follow up at the specialized HF clinic in terms of
guideline adherence, patient compliance in patients with heart failure.

Within the current study patients will be discharged from the heart failure
clinic to primary care under the following conditions; (1) patients are in a
stable condition, (2) patients are optimally up-titrated on medication
(according to the Dutch Multidisciplinary Guideline Chronic Heart Failure), (3)
patients have received optimal education and counselling on pre-specified
issues. Furthermore, close cooperation between secondary and primary care in
terms of back referral to or consultation of the HF clinic will be provided as
it is an important condition to facilitate optimal follow-up (conform the Dutch
Multidisciplinary Guideline Chronic Heart Failure).
The study objective will be addressed by using the design of a Randomized
Controlled Trial. In total 200 patients will be randomly assigned to follow-up
in primary care or to follow-up by the heart failure clinic. Data will be
collected at baseline and after a 12 months follow-up period. Additionally,
descriptive data will be collected at 18 months on limited parameters and the
natural conduct of care after disconnection from the randomization.

The intervention consists of follow-up care during 12 month by either primary
care (GP and specialized nurs) or the heart failure clinic. Both will use the
same national guideline

Patients in both study groups will receive care following the Dutch
Multidisciplinary Guideline on Chronic Heart Failure. Therefore there are no
risks involved for patients participating in the study.
The burden for patients consists of 2 assessments; at baseline and at the end
of the study. Patients will be asked to fill in questionnaires (20 minutes) and
blood samples will be taken during routine (according to the national
guideline) blood punctures. The end of study assessment will take place within
the HF clinic, an appointment will be scheduled.
Participating patients will also be asked to fill in a weight diary for a
period of 4 weeks. Also partner of patients (if available) will be asked to
fill in a questionnaire.