NCT04977362

Interdisciplinary Perioperative Care in Minimally-invasive Heart Valve Surgery

Interdisciplinary and Cross-sectoral Perioperative Care Model in the Cardiac Surgery: Implementation in the Setting of Minimally-invasive Heart Valve Surgery (INCREASE)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Heart Valve Diseases

Interventions

Type	Name	Description
OTHER	Enhanced Recovery After Surgery	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.
OTHER	Treatment as Usual	treatment as usual according to standard care in heart valve surgery

Timeline

• Start date: 2021-07-01
• Primary completion: 2024-03-24
• Completion: 2024-06-30
• First posted: 2021-07-26
• Last updated: 2024-12-12

Locations

2 sites across 1 country: Germany