1304: Implementing a New Nurse Co-Ordinated Transmurale Approach in Congestive Heart Failure Care. The Chance @ Home-Study;(The Congestive Heart Failure Advanced Nursing Care @ Home-Study)

Background: Congestive Heart failure [CHF] is, especially in elderly patients, an increasing problem. The quality of life [QOL] in this patient group is considerable affected by frequent (re) hospitalisation. Prevention of this hospitalisation has major benefits for the patient self and the healthcare providers; improved QOL, decreased clinical care consumption and shorter waiting lists.

Objectives: In the CHANCE @ HOME-study the feasibility and effects of, direct home based administration of intra-venous [IV] diuretics by Advanced Practice Nurses [APN] or Cardiac Nurse Specialists [CNS], will be evaluated, with the intention to prevent the traditional hospitalisation and to improve the QOL. Additional the value and feasibility of determination of B-type (N terminated) pro natriuretic peptide in the home based setting will be assessed.

Methods: In a randomised, single centre design, after screening on the emergency room [ER] and informed consent, CHF-patients (NYHA-class III/IV) with an indication for IV-diuretics (n = 152) will be randomised to:

A Immediate home based IV-therapy, education and support, performed and co-ordinated by APN/CNS. Additionally, 24/7 back-up by telephone is available.

B Traditional in hospital treatment on the cardiac care unit.

The home based intervention group will receive, in case of deterioration of the heart failure situation, after succeeded initial treatment, repeated home based IV-therapy, until a half year after inclusion in the study.

Two weeks after initial treatment and two-monthly thereafter, or more frequent when needed, the effect of the medication regime will be reassessed and education and support is given to optimise the CHF-situation, for all patients of both groups, on the APN/CNS co-ordinated heart failure outpatient-clinic.

Endpoints: The primary endpoint of the study is:

Change in QOL as assessed by a validated Dutch version of the Minnesota Living with Heart Failure Questionnaire.

The secondary endpoints of the study are:

Change in QOL as assessed by a validated Dutch version of the Short Form-36 & the ‘Cantrils ladder of life’.

Frequency of re-hospitalisation and length of stay.

Effect on primary care consumption (number of CHF related contacts with the general practitioner).

Changes in plasma levels of Nt pro-BNP.

Incidence of cardiovascular mortality.

Study schedule: The total study length is approximately 3 years including a pilot phase (n = 15). Expected study start is February 2004.