Clinical trial NCT04977362: Interdisciplinary Perioperative Care in Minimally-invasive Heart Valve Surgery
Official title: Interdisciplinary and Cross-sectoral Perioperative Care Model in the Cardiac Surgery: Implementation in the Setting of Minimally-invasive Heart Valve Surgery (INCREASE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Valve Diseases
Keywords: randomized controlled trial
enhanced recovery after surgery
minimally invasive surgery
postanesthesia care unit
physiotherapy
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: BARMER
name: University Hospital Augsburg
First posted: 2021-07-26
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Hospitalization
timeFrame: twelve months
measure: Six Minute Walk Test
timeFrame: day of discharge (approx. 5 - 10 days after operation)
Secondary outcomes:
measure: Goal Attainment Scale (GAS)
timeFrame: three months
measure: Goal Attainment Scale (GAS)
timeFrame: twelve months
measure: HeartQoL
timeFrame: three months
measure: HeartQoL
timeFrame: twelve months
measure: Costs
timeFrame: up to 10 days
Other outcomes:
measure: European Health Literacy Questionnaire (HLS-EU-Q16)
timeFrame: day of discharge (approx. 5 - 10 days after operation)
measure: European Health Literacy Questionnaire (HLS-EU-Q16)
timeFrame: twelve months
measure: Brief Illnness Perception Questionnaire (BIPQ)
timeFrame: day of discharge (approx. 5 - 10 days after operation)
measure: Brief Illnness Perception Questionnaire (BIPQ)
timeFrame: twelve months
measure: Treatment Expectation Questionnaire (TEX-Q)
timeFrame: day of discharge (approx. 5 - 10 days after operation)
measure: Treatment Expectation Questionnaire (TEX-Q)
timeFrame: three months
measure: Treatment Expectation Questionnaire (TEX-Q)
timeFrame: twelve months
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: day of discharge (approx. 5 - 10 days after operation)
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: three months
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: twelve months
measure: Generalized Anxiety Disorder-2 (GAD-2)
timeFrame: day of discharge (approx. 5 - 10 days after operation)
measure: Generalized Anxiety Disorder-2 (GAD-2)
timeFrame: three months
measure: Generalized Anxiety Disorder-2 (GAD-2)
timeFrame: twelve months
measure: Cardiac Anxiety Questionnaire (CAQ)
timeFrame: day of discharge (approx. 5 - 10 days after operation)
measure: Cardiac Anxiety Questionnaire (CAQ)
timeFrame: three months
measure: Cardiac Anxiety Questionnaire (CAQ)
timeFrame: twelve months
measure: Life Orientation Test - revised (LOT-R)
timeFrame: day of discharge (approx. 5 - 10 days after operation)
measure: Somatic Symptom Scale-8 (SSS-8)
timeFrame: day of discharge (approx. 5 - 10 days after operation)
measure: Somatic Symptom Scale-8 (SSS-8)
timeFrame: three months
measure: Somatic Symptom Scale-8 (SSS-8)
timeFrame: twelve months
measure: Somatic Symptom Disorder - B Criteria Scale (SSD-12)
timeFrame: day of discharge (approx. 5 - 10 days after operation)
measure: Somatic Symptom Disorder - B Criteria Scale (SSD-12)
timeFrame: three months
measure: Somatic Symptom Disorder - B Criteria Scale (SSD-12)
timeFrame: twelve months
measure: International Physical Activity Questionnaire Short Form (IPAQ)
timeFrame: day of discharge (approx. 5 - 10 days after operation)
measure: International Physical Activity Questionnaire Short Form (IPAQ)
timeFrame: twelve months
measure: Hand Dynamometer
timeFrame: day of discharge (approx. 5 - 10 days after operation)
measure: Hand Dynamometer
timeFrame: twelve months
measure: 1 Minute Sit to Stand Test (1STS)
timeFrame: day of discharge (approx. 5 - 10 days after operation)
measure: 1 Minute Sit to Stand Test (1STS)
timeFrame: twelve months
measure: Timed Up and Go (TUG)
timeFrame: day of discharge (approx. 5 - 10 days after operation)
measure: Timed Up and Go (TUG)
timeFrame: twelve months
measure: Six Minute Walk Test
timeFrame: twelve months
measure: Goal Attainment Scale (GAS)
timeFrame: day of discharge (approx. 5 - 10 days after operation)
measure: Readiness for Hospital Discharge Scale (RHDS)
timeFrame: day of discharge (approx. 5 - 10 days after operation)
measure: 5-level EQ-5D Health-related Quality of Life Questionnaire (EQ-5D-5L)
timeFrame: three months
measure: 5-level EQ-5D Health-related Quality of Life Questionnaire (EQ-5D-5L)
timeFrame: twelve months
measure: Questionnaire for Health-Related Resource Use in an Elderly Population (FIMA)
timeFrame: twelve months
Locations:
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg
state: Bavaria
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Evaldas Girdauskas, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.