Interdisciplinary Perioperative Care in Minimally-invasive Heart Valve Surgery

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Heart Valve Diseases

Intervention / Treatment
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* Other: Enhanced Recovery After Surgery
* Other: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ERAS protocol (intervention group)<br>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. | Other: Enhanced Recovery After Surgery<br>* 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.<br>* Other names: ERAS;|
| Active Comparator: Treatment as usual (control group)<br>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. | Other: Treatment as Usual<br>* treatment as usual according to standard care in heart valve surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization | number of hospitalized days due to cardiac reasons | twelve months | 
| Six Minute Walk Test | physical capacity expressed with the walking distance in meters | day of discharge (approx. 5 - 10 days after operation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | twelve months | 
| HeartQoL | health-related quality of life; 14 items, min 0, max 42, higher scores indicating better health-related quality of life | three months | 
| HeartQoL | health-related quality of life; 14 items, min 0, max 42, higher scores indicating better health-related quality of life | 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 | up to 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized controlled trial, enhanced recovery after surgery, minimally invasive surgery, postanesthesia care unit, physiotherapy