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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04977362
Recruitment Status : Recruiting
First Posted : July 26, 2021
Last Update Posted : August 24, 2022
Sponsor:
Collaborators:
BARMER
University Hospital Augsburg
Information provided by (Responsible Party):
Evaldas Girdauskas, Universitätsklinikum Hamburg-Eppendorf

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heart Valve Diseases Other: Enhanced Recovery After Surgery Other: Treatment as Usual Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: Single (Investigator)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Interdisciplinary and Cross-sectoral Perioperative Care Model in the Cardiac Surgery: Implementation in the Setting of Minimally-invasive Heart Valve Surgery (INCREASE)
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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:
  • fast track
  • rapid recovery
  • ERAS
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


Outcome Measures
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Primary Outcome Measures :
  1. Hospitalization [ Time Frame: twelve months ]
    number of hospitalized days due to cardiac reasons

  2. Six Minute Walk Test [ Time Frame: day of discharge (approx. 5 - 10 days after operation) ]
    physical capacity expressed with the walking distance in meters


Secondary Outcome Measures :
  1. Goal Attainment Scale (GAS) [ Time Frame: three months ]
    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

  2. Goal Attainment Scale (GAS) [ Time Frame: twelve months ]
    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

  3. HeartQoL [ Time Frame: three months ]
    health-related quality of life; 14 items, min 0, max 42, higher scores indicating better health-related quality of life

  4. HeartQoL [ Time Frame: twelve months ]
    health-related quality of life; 14 items, min 0, max 42, higher scores indicating better health-related quality of life

  5. Costs [ Time Frame: up to 10 days ]
    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


Other Outcome Measures:
  1. European Health Literacy Questionnaire (HLS-EU-Q16) [ Time Frame: day of discharge (approx. 5 - 10 days after operation) ]
    health literacy: 16 items, min 16, max 64, higher scores indicating lower health literacy

  2. European Health Literacy Questionnaire (HLS-EU-Q16) [ Time Frame: twelve months ]
    health literacy: 16 items, min 16, max 64, higher scores indicating lower health literacy

  3. Brief Illnness Perception Questionnaire (BIPQ) [ Time Frame: day of discharge (approx. 5 - 10 days after operation) ]
    individual concept of illness; 8 items, min 0, max 80, higher scores indicating worse illness perception

  4. Brief Illnness Perception Questionnaire (BIPQ) [ Time Frame: twelve months ]
    individual concept of illness; 8 items, min 0, max 80, higher scores indicating worse illness perception

  5. Treatment Expectation Questionnaire (TEX-Q) [ Time Frame: day of discharge (approx. 5 - 10 days after operation) ]
    treatment expectations; 15 items, min 0, max 150, higher scores indicating higher expectations of effects of the treatment

  6. Treatment Expectation Questionnaire (TEX-Q) [ Time Frame: three months ]
    treatment expectations; 15 items, min 0, max 150, higher scores indicating higher expectations of effects of the treatment

  7. Treatment Expectation Questionnaire (TEX-Q) [ Time Frame: twelve months ]
    treatment expectations; 15 items, min 0, max 150, higher scores indicating higher expectations of effects of the treatment

  8. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: day of discharge (approx. 5 - 10 days after operation) ]
    depressive symptoms; 9 items, min 0, max 27, higher scores indicating higher depressive symptoms

  9. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: three months ]
    depressive symptoms; 9 items, min 0, max 27, higher scores indicating higher depressive symptoms

  10. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: twelve months ]
    depressive symptoms; 9 items, min 0, max 27, higher scores indicating higher depressive symptoms

  11. Generalized Anxiety Disorder-2 (GAD-2) [ Time Frame: day of discharge (approx. 5 - 10 days after operation) ]
    anxiety symptoms; 2 items, min 0, max 6, higher scores indicating higher anxiety symptoms

  12. Generalized Anxiety Disorder-2 (GAD-2) [ Time Frame: three months ]
    anxiety symptoms; 2 items, min 0, max 6, higher scores indicating higher anxiety symptoms

  13. Generalized Anxiety Disorder-2 (GAD-2) [ Time Frame: twelve months ]
    anxiety symptoms; 2 items, min 0, max 6, higher scores indicating higher anxiety symptoms

  14. Cardiac Anxiety Questionnaire (CAQ) [ Time Frame: day of discharge (approx. 5 - 10 days after operation) ]
    cardiac anxiety; 17 items, min 0, max 68, higher scores indicating higher cardiac anxiety

  15. Cardiac Anxiety Questionnaire (CAQ) [ Time Frame: three months ]
    cardiac anxiety; 17 items, min 0, max 68, higher scores indicating higher cardiac anxiety

  16. Cardiac Anxiety Questionnaire (CAQ) [ Time Frame: twelve months ]
    cardiac anxiety; 17 items, min 0, max 68, higher scores indicating higher cardiac anxiety

  17. Life Orientation Test - revised (LOT-R) [ Time Frame: day of discharge (approx. 5 - 10 days after operation) ]
    optimism; 10 items, min 0, max 24, higher scores indicating higher optimism

  18. Somatic Symptom Scale-8 (SSS-8) [ Time Frame: day of discharge (approx. 5 - 10 days after operation) ]
    somatic symptom burden; 8 items, min 0, max 32, higher scores indicating higher somatic symptom burden

  19. Somatic Symptom Scale-8 (SSS-8) [ Time Frame: three months ]
    somatic symptom burden; 8 items, min 0, max 32, higher scores indicating higher somatic symptom burden

  20. Somatic Symptom Scale-8 (SSS-8) [ Time Frame: twelve months ]
    somatic symptom burden; 8 items, min 0, max 32, higher scores indicating higher somatic symptom burden

  21. Somatic Symptom Disorder - B Criteria Scale (SSD-12) [ Time Frame: day of discharge (approx. 5 - 10 days after operation) ]
    coping with somatic symptoms; 12 items, min 0, max 48, higher scores indicating worse coping with somatic symptoms

  22. Somatic Symptom Disorder - B Criteria Scale (SSD-12) [ Time Frame: three months ]
    coping with somatic symptoms; 12 items, min 0, max 48, higher scores indicating worse coping with somatic symptoms

  23. Somatic Symptom Disorder - B Criteria Scale (SSD-12) [ Time Frame: twelve months ]
    coping with somatic symptoms; 12 items, min 0, max 48, higher scores indicating worse coping with somatic symptoms

  24. International Physical Activity Questionnaire Short Form (IPAQ) [ Time Frame: day of discharge (approx. 5 - 10 days after operation) ]
    level of physical activity

  25. International Physical Activity Questionnaire Short Form (IPAQ) [ Time Frame: twelve months ]
    level of physical activity

  26. Hand Dynamometer [ Time Frame: day of discharge (approx. 5 - 10 days after operation) ]
    hand grip strength

  27. Hand Dynamometer [ Time Frame: twelve months ]
    hand grip strength

  28. 1 Minute Sit to Stand Test (1STS) [ Time Frame: day of discharge (approx. 5 - 10 days after operation) ]
    physical capacity expressed with the number of repetitions

  29. 1 Minute Sit to Stand Test (1STS) [ Time Frame: twelve months ]
    physical capacity expressed with the number of repetitions

  30. Timed Up and Go (TUG) [ Time Frame: day of discharge (approx. 5 - 10 days after operation) ]
    physical capacity expressed with the duration in seconds

  31. Timed Up and Go (TUG) [ Time Frame: twelve months ]
    physical capacity expressed with the duration in seconds

  32. Six Minute Walk Test [ Time Frame: twelve months ]
    physical capacity expressed with the walking distance in meters

  33. Goal Attainment Scale (GAS) [ Time Frame: day of discharge (approx. 5 - 10 days after operation) ]
    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

  34. Readiness for Hospital Discharge Scale (RHDS) [ Time Frame: day of discharge (approx. 5 - 10 days after operation) ]
    readiness for hospital discharge; 9 items, min 0, max 36, higher scores indicating higher readniss to discharge

  35. 5-level EQ-5D Health-related Quality of Life Questionnaire (EQ-5D-5L) [ Time Frame: three months ]
    health-related quality of life; 6 items, interpretation following an algorythm between 1 (best possible health condition) and <0 (worst possible health condition)

  36. 5-level EQ-5D Health-related Quality of Life Questionnaire (EQ-5D-5L) [ Time Frame: twelve months ]
    health-related quality of life; 6 items, interpretation following an algorythm between 1 (best possible health condition) and <0 (worst possible health condition)

  37. Questionnaire for Health-Related Resource Use in an Elderly Population (FIMA) [ Time Frame: twelve months ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04977362


Contacts
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Contact: Evaldas Girdauskas, Prof. +49 821 400 2671 herzchirurgie@uk-augsburg.de
Contact: Jelena Bagnjuk, MSc + 49 40 7410 58685 j.bagnjuk@uke.de

Locations
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Germany
Universitätsklinikum Augsburg Not yet recruiting
Augsburg, Bavaria, Germany, 86156
Contact: Evaldas Girdauskas, Prof.    +49 821 400 2671    herzchirurgie@uk-augsburg.de   
Universitätsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Jelena Bagnjuk, MSc    + 49 40 7410 58685    j.bagnjuk@uke.de   
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
BARMER
University Hospital Augsburg
Investigators
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Principal Investigator: Evaldas Girdauskas, Prof. Universitätsklinikum Hamburg-Eppendorf
More Information
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Additional Information:

Publications:

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Responsible Party: Evaldas Girdauskas, Prof. Dr. med., Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT04977362    
Other Study ID Numbers: 1564/108
First Posted: July 26, 2021    Key Record Dates
Last Update Posted: August 24, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Evaldas Girdauskas, Universitätsklinikum Hamburg-Eppendorf:
randomized controlled trial
enhanced recovery after surgery
minimally invasive surgery
postanesthesia care unit
physiotherapy
Additional relevant MeSH terms:
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Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases