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| Name | Class |
|---|---|
| BARMER | OTHER |
| University Hospital Augsburg | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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) |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evaldas Girdauskas, Prof. | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Augsburg | Augsburg | Bavaria | 86156 | Germany | ||
| Universitätsklinikum Hamburg-Eppendorf |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32271849 | Background | 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. | |
| 33743698 |
| Label | URL |
|---|---|
| summary of the project on the sponsor's website | View source |
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| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000080482 | Enhanced Recovery After Surgery |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D013514 | Surgical Procedures, Operative |
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Randomized Controlled Trial
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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.
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| Treatment as Usual | Other | treatment as usual according to standard care in heart valve surgery |
|
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 |
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 |
| Hamburg |
| 20246 |
| Germany |
| 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. |
| 35739541 | 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. |