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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Valve Diseases
• Intervention / Treatment: Other: Enhanced Recovery After Surgery; Other: Treatment as Usual

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg-Eppendorf
  • Bavaria
    • Augsburg, Bavaria, Germany, 86156
      • Universitätsklinikum Augsburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ERAS protocol (intervention group); 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; 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 Names: ERAS; fast track; rapid recovery
Active Comparator: Treatment as usual (control group); 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; treatment as usual according to standard care in heart valve surgery

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
European Health Literacy Questionnaire (HLS-EU-Q16)	health literacy: 16 items, min 16, max 64, higher scores indicating lower health literacy	day of discharge (approx. 5 - 10 days after operation)
European Health Literacy Questionnaire (HLS-EU-Q16)	health literacy: 16 items, min 16, max 64, higher scores indicating lower health literacy	twelve months
Brief Illnness Perception Questionnaire (BIPQ)	individual concept of illness; 8 items, min 0, max 80, higher scores indicating worse illness perception	day of discharge (approx. 5 - 10 days after operation)
Brief Illnness Perception Questionnaire (BIPQ)	individual concept of illness; 8 items, min 0, max 80, higher scores indicating worse illness perception	twelve months
Treatment Expectation Questionnaire (TEX-Q)	treatment expectations; 15 items, min 0, max 150, higher scores indicating higher expectations of effects of the treatment	day of discharge (approx. 5 - 10 days after operation)
Treatment Expectation Questionnaire (TEX-Q)	treatment expectations; 15 items, min 0, max 150, higher scores indicating higher expectations of effects of the treatment	three months
Treatment Expectation Questionnaire (TEX-Q)	treatment expectations; 15 items, min 0, max 150, higher scores indicating higher expectations of effects of the treatment	twelve months
Patient Health Questionnaire-9 (PHQ-9)	depressive symptoms; 9 items, min 0, max 27, higher scores indicating higher depressive symptoms	day of discharge (approx. 5 - 10 days after operation)
Patient Health Questionnaire-9 (PHQ-9)	depressive symptoms; 9 items, min 0, max 27, higher scores indicating higher depressive symptoms	three months
Patient Health Questionnaire-9 (PHQ-9)	depressive symptoms; 9 items, min 0, max 27, higher scores indicating higher depressive symptoms	twelve months
Generalized Anxiety Disorder-2 (GAD-2)	anxiety symptoms; 2 items, min 0, max 6, higher scores indicating higher anxiety symptoms	day of discharge (approx. 5 - 10 days after operation)
Generalized Anxiety Disorder-2 (GAD-2)	anxiety symptoms; 2 items, min 0, max 6, higher scores indicating higher anxiety symptoms	three months
Generalized Anxiety Disorder-2 (GAD-2)	anxiety symptoms; 2 items, min 0, max 6, higher scores indicating higher anxiety symptoms	twelve months
Cardiac Anxiety Questionnaire (CAQ)	cardiac anxiety; 17 items, min 0, max 68, higher scores indicating higher cardiac anxiety	day of discharge (approx. 5 - 10 days after operation)
Cardiac Anxiety Questionnaire (CAQ)	cardiac anxiety; 17 items, min 0, max 68, higher scores indicating higher cardiac anxiety	three months
Cardiac Anxiety Questionnaire (CAQ)	cardiac anxiety; 17 items, min 0, max 68, higher scores indicating higher cardiac anxiety	twelve months
Life Orientation Test - revised (LOT-R)	optimism; 10 items, min 0, max 24, higher scores indicating higher optimism	day of discharge (approx. 5 - 10 days after operation)
Somatic Symptom Scale-8 (SSS-8)	somatic symptom burden; 8 items, min 0, max 32, higher scores indicating higher somatic symptom burden	day of discharge (approx. 5 - 10 days after operation)
Somatic Symptom Scale-8 (SSS-8)	somatic symptom burden; 8 items, min 0, max 32, higher scores indicating higher somatic symptom burden	three months
Somatic Symptom Scale-8 (SSS-8)	somatic symptom burden; 8 items, min 0, max 32, higher scores indicating higher somatic symptom burden	twelve months
Somatic Symptom Disorder - B Criteria Scale (SSD-12)	coping with somatic symptoms; 12 items, min 0, max 48, higher scores indicating worse coping with somatic symptoms	day of discharge (approx. 5 - 10 days after operation)
Somatic Symptom Disorder - B Criteria Scale (SSD-12)	coping with somatic symptoms; 12 items, min 0, max 48, higher scores indicating worse coping with somatic symptoms	three months
Somatic Symptom Disorder - B Criteria Scale (SSD-12)	coping with somatic symptoms; 12 items, min 0, max 48, higher scores indicating worse coping with somatic symptoms	twelve months
International Physical Activity Questionnaire Short Form (IPAQ)	level of physical activity	day of discharge (approx. 5 - 10 days after operation)
International Physical Activity Questionnaire Short Form (IPAQ)	level of physical activity	twelve months
Hand Dynamometer	hand grip strength	day of discharge (approx. 5 - 10 days after operation)
Hand Dynamometer	hand grip strength	twelve months
1 Minute Sit to Stand Test (1STS)	physical capacity expressed with the number of repetitions	day of discharge (approx. 5 - 10 days after operation)
1 Minute Sit to Stand Test (1STS)	physical capacity expressed with the number of repetitions	twelve months
Timed Up and Go (TUG)	physical capacity expressed with the duration in seconds	day of discharge (approx. 5 - 10 days after operation)
Timed Up and Go (TUG)	physical capacity expressed with the duration in seconds	twelve months
Six Minute Walk Test	physical capacity expressed with the walking distance in meters	twelve 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	day of discharge (approx. 5 - 10 days after operation)
Readiness for Hospital Discharge Scale (RHDS)	readiness for hospital discharge; 9 items, min 0, max 36, higher scores indicating higher readniss to discharge	day of discharge (approx. 5 - 10 days after operation)
5-level EQ-5D Health-related Quality of Life Questionnaire (EQ-5D-5L)	health-related quality of life; 6 items, interpretation following an algorythm between 1 (best possible health condition) and <0 (worst possible health condition)	three months
5-level EQ-5D Health-related Quality of Life Questionnaire (EQ-5D-5L)	health-related quality of life; 6 items, interpretation following an algorythm between 1 (best possible health condition) and <0 (worst possible health condition)	twelve months
Questionnaire for Health-Related Resource Use in an Elderly Population (FIMA)	use of health care services; 11 items collecting numbers of health care services and days of usage, min 0, higher scores indicating higher usage of services	twelve months

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: BARMER; University Hospital Augsburg
• Investigators: Principal Investigator: Evaldas Girdauskas, Prof., Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Erratum In: Trials. 2022 Oct 5;23(1):853. doi: 10.1186/s13063-022-06813-9.

Helpful Links

• summary of the project on the sponsor's website

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): March 24, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: June 18, 2021
• First Submitted That Met QC Criteria: July 21, 2021
• First Posted (Actual): July 26, 2021

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 8, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: randomized controlled trial; physiotherapy; minimally invasive surgery; enhanced recovery after surgery; postanesthesia care unit
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases
• Other Study ID Numbers: 1564/108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No