Interdisciplinary Perioperative Care in Minimally-invasive Heart Valve Surgery (INCREASE)

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

Conditions: Heart Valve Diseases

Treatments: Other: Enhanced Recovery After Surgery; Other: Treatment as Usual

Study type: Interventional

Funder types: Other

Identifiers

NCT04977362

1564/108

Details and patient eligibility

About

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.

Enrollment: 201 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Indication for elective minimally invasive (open) aortic or mitral valve surgery
• Patient's ability to understand the nature and extent of the individual's requirements for participation in the new care setting
• Classification of the patient as "FIT" or "Pre-FRAIL" using the LUCAS functional index (frailty index) (Dapp et al. 2012)

Exclusion criteria

• Limited life expectancy less than one year (e.g., advanced tumor disease)
• Urgent or emergency interventions
• Severe chronic obstructive pulmonary disease (GOLD III or IV)
• Dialysis-dependant renal failure
• Advanced liver cirrhosis (Child stages B + C)
• Severe comorbidities or psychosocial reasons that militate against participation or do not allow for written informed consent (e. g., residual neurological impairment after prior stroke, major restrictions of mobility, neuropsychological disorders, depressive disorder, substance-related addictive disorders)
• Lack of a social environment that can provide supportive patient care
• Previous cardiac surgery (i.e., relative contraindication for minimally invasive technique)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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201 participants in 2 patient groups

ERAS protocol (intervention group)

Experimental group

Description:

The innovative care process in the intervention group is characterized by an interdisciplinary approach according to the previously established enhanced recovery after surgery protocol. This process aims at improving the clinical outcome after cardiac surgery, increasing patient satisfaction and quality of life, enabling early professional reentry and participation, and optimizing the cost-effectiveness of service provision. In addition, intersectoral barriers are being broken down in order to establish an interdisciplinary and cross-sectoral overall care process for patients with heart valve surgery as a new form of care in the future.

Treatment:

Other: Enhanced Recovery After Surgery

Treatment as usual (control group)

Active Comparator group

Description:

The control group undergoes standard heart valve surgery. In this case, no preoperative interventions take place, the patient is operated on the affected heart valve in a minimally invasive procedure without prehabilitation. After surgery, the patient is transfered to an intensive care unit (not a specialized postanesthesia care unit) depending on the individual condition and then transfered to the general ward. Patients receive medical, nursing, and physiotherapeutic care in accordance with current hospital standards.

Treatment:

Other: Treatment as Usual