Heart Valve Diseases
Conditions
Keywords
randomized controlled trial, enhanced recovery after surgery, minimally invasive surgery, postanesthesia care unit, physiotherapy
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.
Interventions
OTHEREnhanced 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.
OTHERTreatment as Usual
treatment as usual according to standard care in heart valve surgery
Sponsors
BARMER
University Hospital Augsburg
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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.
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization | twelve months | number of hospitalized days due to cardiac reasons |
| Six Minute Walk Test | day of discharge (approx. 5 - 10 days after operation) | physical capacity expressed with the walking distance in meters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Goal Attainment Scale (GAS) | 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 |
| HeartQoL | three months | health-related quality of life; 14 items, min 0, max 42, higher scores indicating better health-related quality of life |
| Costs | 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
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Anxiety Questionnaire (CAQ) | day of discharge (approx. 5 - 10 days after operation) | cardiac anxiety; 17 items, min 0, max 68, higher scores indicating higher cardiac anxiety |
| Life Orientation Test - revised (LOT-R) | day of discharge (approx. 5 - 10 days after operation) | optimism; 10 items, min 0, max 24, higher scores indicating higher optimism |
| Somatic Symptom Scale-8 (SSS-8) | 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 |
| Somatic Symptom Disorder - B Criteria Scale (SSD-12) | 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 |
| International Physical Activity Questionnaire Short Form (IPAQ) | day of discharge (approx. 5 - 10 days after operation) | level of physical activity |
| Hand Dynamometer | day of discharge (approx. 5 - 10 days after operation) | hand grip strength |
| European Health Literacy Questionnaire (HLS-EU-Q16) | day of discharge (approx. 5 - 10 days after operation) | health literacy: 16 items, min 16, max 64, higher scores indicating lower health literacy |
| Timed Up and Go (TUG) | day of discharge (approx. 5 - 10 days after operation) | physical capacity expressed with the duration in seconds |
| Six Minute Walk Test | twelve months | physical capacity expressed with the walking distance in meters |
| Goal Attainment Scale (GAS) | 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 |
| Readiness for Hospital Discharge Scale (RHDS) | 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 |
| 5-level EQ-5D Health-related Quality of Life Questionnaire (EQ-5D-5L) | 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) |
| Questionnaire for Health-Related Resource Use in an Elderly Population (FIMA) | 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 |
| 1 Minute Sit to Stand Test (1STS) | day of discharge (approx. 5 - 10 days after operation) | physical capacity expressed with the number of repetitions |
| Brief Illnness Perception Questionnaire (BIPQ) | 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 |
| Treatment Expectation Questionnaire (TEX-Q) | 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 |
| Patient Health Questionnaire-9 (PHQ-9) | day of discharge (approx. 5 - 10 days after operation) | depressive symptoms; 9 items, min 0, max 27, higher scores indicating higher depressive symptoms |
| Generalized Anxiety Disorder-2 (GAD-2) | day of discharge (approx. 5 - 10 days after operation) | anxiety symptoms; 2 items, min 0, max 6, higher scores indicating higher anxiety symptoms |
Countries
Germany
Outcome results
None listed