Research >> SP15 - INH-Study

Disease Manifestation and Disease Management in Chronic Heart Failure - Project description

Background

There are hardly any structured care and support programs for patients with chronic heart failure. However, these are urgently needed: the prevalence of heart failure is steadily increasing, due to demographic change and advancements in acute therapy. Treatment of these frequently multimorbid patients is complex, time-consuming and requires innovative strategies that improve continuity between different of health care, and interrelate in particular in- and outpatient treatment.

Objective

A randomized, open trial is investigating the impact of a structured disease management program (Network Care [NC]) compared to Usual Care (UC). Network care includes evidence-based medication, enhancement of compliance via specialized nursing staff, patient monitoring by telephone and patient education. In order to document the sustainability of the intervention, an extension of the post-observation from 6 to 18 months and an increase in the number of cases to n=1000 was requested and approved, even before the end of recruitment of the first cohort of n=700. The study clarifies the effect of Network Care compared to Usual Care with regard to 1) death and hospitalization due to any cause (combined primary end point) and 2) components of the primary end point separately, cardiovascular death, quality of life, depression, days alive and out of hospital, guideline-compliant pharmacotherapy according to guidelines, health economy.

Implementation

In this multidisciplinary patient care and support network, 9 internal medicine and cardiological hospitals screen and recruit all patients hospitalized for symptomatic heart failure. Specialist nurses at the study headquarters recruit the patients into the program, if after best possible cardiac recompensation the left ventricular ejection fraction has remained significantly impaired (< 40%); all patients receive the INH study pass, in which all consumption of medical resources is to be documented. NC patients receive, in addition, an educational booklet containing relevant information on heart failure and a symptom calendar. After discharge, patients are regularly monitored via telephone by the nurses according to a pre-defined schedule, and receive education about self-empowerment and -monitoring. typical signs of worsening disease, medication, life style aspects including diet and heart-failure-related psychological issues.

Six-month follow-up of the primary cohort (n=700): The average age of the patients was 68 years; 29% were women, and 40% had severe heart failure. In 180 days, 51 patients (14%) died under Usual Care, while 28 patients (8%) died in Network Care (relative risk reduction 43%; p=0.018). While there was an initial increase in the number of days hospitalized among the NC patients, this figure declined from the third month onward, so that days alive and out of hospital gained per patient amounted to 4.6 days after 6 months. In the group of NC patients, the severity of heart failure decreased to a significantly greater extent and the quality of life increased (all p<0.03). After six months, NC patients were treated with higher mean equivalence doses of betablockers and ACE inhibitors / ARBs.

Added value via Networking

Broad supraregional implementation of the program should be further investigated within the competence network heart failure to facilitate better estimation of the potential for use in routine care. By means of networking of 9 hospitals, 30 cardiologists in private practice and more than 400 primary care physicians and internists working as primary care physicians, a local high-performance research and health care network was created thus providing a sustainable basis for the processing of scientific issues and the care of patients with heart failure in the future as well. The implementation of the program is documented in detail (HeartNetCare HF Würzburg©), and is currently being tested in a non-university setting under expert supervision. The results could be implemented in the national health care guideline. Furthermore, it is expected that public insurance companies will recognize the importance of this non-pharmacological intervention and will help to facilitate sustainable reimbursement strategies.