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Interdisciplinary and Cross-sectoral Perioperative Care Model in the Cardiac Surgery: Implementation in the Setting of Minimally-invasive Heart Valve Surgery (INCREASE)
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Universitätsklinikum Augsburg
Augsburg, Bavaria, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Start Date
July 1, 2021
Primary Completion Date
March 24, 2024
Completion Date
June 30, 2024
Last Updated
December 12, 2024
201
ACTUAL participants
Enhanced Recovery After Surgery
OTHER
Treatment as Usual
OTHER
Lead Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
NCT05208567
NCT03142152
Data Source & Attribution
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