Interdisciplinary Perioperative Care in Minimally-invasive Heart Valve Surgery

NCT04977362 | Completed

• 1 other identifier: 1564/108
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

randomized controlled trial; enhanced recovery after surgery; minimally invasive surgery; postanesthesia care unit; physiotherapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Goal Attainment Scale (GAS)

  three months

• Goal Attainment Scale (GAS)

  twelve months

• HeartQoL

  three months

• HeartQoL

  twelve months

• Costs

  up to 10 days

Other Outcomes (37)

• European Health Literacy Questionnaire (HLS-EU-Q16)

  day of discharge (approx. 5 - 10 days after operation)

• European Health Literacy Questionnaire (HLS-EU-Q16)

  twelve months

• Brief Illnness Perception Questionnaire (BIPQ)

  day of discharge (approx. 5 - 10 days after operation)

Study Arms (2)

ERAS protocol (intervention group)

EXPERIMENTAL

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

Treatment as usual (control group)

ACTIVE COMPARATOR

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

Interventions

Enhanced Recovery After Surgery OTHER

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.

Also known as: fast track, rapid recovery, ERAS

ERAS protocol (intervention group)

Treatment as Usual OTHER

treatment as usual according to standard care in heart valve surgery

Treatment as usual (control group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• BARMER: collaborator
• University Hospital Augsburg: collaborator

Study Sites (2)

Universitätsklinikum Augsburg

Augsburg, Bavaria, 86156, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (3)

• Kubitz JC, Schulte-Uentrop L, Zoellner C, Lemke M, Messner-Schmitt A, Kalbacher D, Sill B, Reichenspurner H, Koell B, Girdauskas E. Establishment of an enhanced recovery after surgery protocol in minimally invasive heart valve surgery. PLoS One. 2020 Apr 9;15(4):e0231378. doi: 10.1371/journal.pone.0231378. eCollection 2020.

  PMID: 32271849 BACKGROUND

• Petersen J, Kloth B, Konertz J, Kubitz J, Schulte-Uentrop L, Ketels G, Reichenspurner H, Girdauskas E. Economic impact of enhanced recovery after surgery protocol in minimally invasive cardiac surgery. BMC Health Serv Res. 2021 Mar 20;21(1):254. doi: 10.1186/s12913-021-06218-5.

  PMID: 33743698 BACKGROUND

• Klotz SGR, Ketels G, Behrendt CA, Konig HH, Kohlmann S, Lowe B, Petersen J, Stock S, Vettorazzi E, Zapf A, Zastrow I, Zollner C, Reichenspurner H, Girdauskas E. Interdisciplinary and cross-sectoral perioperative care model in cardiac surgery: implementation in the setting of minimally invasive heart valve surgery (INCREASE)-study protocol for a randomized controlled trial. Trials. 2022 Jun 23;23(1):528. doi: 10.1186/s13063-022-06455-x.

  PMID: 35739541 BACKGROUND

Related Links

• summary of the project on the sponsor's website

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

Enhanced Recovery After Surgery; Therapeutics

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Surgical Procedures, Operative

Study Officials

• Evaldas Girdauskas, Prof.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: All scientists and statisticans involved in the analysis of the study will be blinded to the allocation of participants and will receive only pseudomized data from the study coordinator, who organises data collection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: July 26, 2021
• Study Start: July 1, 2021
• Primary Completion: March 24, 2024
• Study Completion: June 30, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)