Valvular heart diseases are among the most common cardiac pathologies in adult patients in Germany. Currently, the process of care before, during and after heart valve surgery does not follow a standardized and interdisciplinary optimal approach. An approach already established in other surgical disciplines is the Enhanced Recovery After Surgery (ERAS) protocol, which aims at optimizing the recovery process of patients. Within the INCREASE study, a care process inspired by the ERAS protocol will be established at the University Heart and Vascular Center (UHZ) of the University Medical Center Hamburg-Eppendorf (UKE) and the University Medical Center Augsburg (UKA). Executing the study at two facilities in different regions in Germany will help to demonstrate transferability of the process of care. The effectiveness of this process compared to the current treatment approach will be investigated in a randomized controlled trial. A total of 186 patients will be allocated by chance either to the intervention group (ERAS protocol) or the control group (treatment as usual). Patients in the intervention group will receive an optimized interdisciplinary care protocol including medical, nursing, physiotherapeutical and psychotherapeutical interventions. Measurements of effectiveness are the number of hospitalized days (due to cardiac causes) within one year and the physical condition of the patient as measured by the 6-minute walk test (6MWT) on the day of discharge.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
201
Enhanced recovery after surgery is a multimodal, transdisciplinary care approach for patients undergoing surgical procedures. It is implemented in various surgical specialties, among others in cardiac surgery. The care approach aims at promotion of recovery of the patients throughout their perioperative process, reduction of complications, and early return to normal activities.
treatment as usual according to standard care in heart valve surgery
Universitätsklinikum Augsburg
Augsburg, Bavaria, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Hospitalization
number of hospitalized days due to cardiac reasons
Time frame: twelve months
Six Minute Walk Test
physical capacity expressed with the walking distance in meters
Time frame: day of discharge (approx. 5 - 10 days after operation)
Goal Attainment Scale (GAS)
level of attainment of individual goal: +2 = much more than expected, +1 = somewhat more than expected, 0 = goal achieved than expected, -1 = somewhat less than expected, -2 = much less than expected
Time frame: three months
Goal Attainment Scale (GAS)
level of attainment of individual goal: +2 = much more than expected, +1 = somewhat more than expected, 0 = goal achieved than expected, -1 = somewhat less than expected, -2 = much less than expected
Time frame: twelve months
HeartQoL
health-related quality of life; 14 items, min 0, max 42, higher scores indicating better health-related quality of life
Time frame: three months
HeartQoL
health-related quality of life; 14 items, min 0, max 42, higher scores indicating better health-related quality of life
Time frame: twelve months
Costs
direct costs in € associated with the operative procedure and the initial hospitalization using diagnosis related groups as classification system, in which diagnoses and treatments are valued according to their necessary economical expenditure
Time frame: up to 10 days
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