Interdisciplinary Perioperative Care in Minimally-invasive Heart Valve Surgery

Heart Valve Diseases Clinical Trial

— INCREASE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04977362
• Other study ID #: 1564/108
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: June 2024

Study information

• Verified date: December 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 201
• Est. completion date: June 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Heart Valve Diseases

Intervention

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.
• Treatment as Usual
treatment as usual according to standard care in heart valve surgery

Locations

Country	Name	City	State
Germany	Universitätsklinikum Augsburg	Augsburg	Bavaria
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg

Sponsors (3)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	BARMER, University Hospital Augsburg

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	European Health Literacy Questionnaire (HLS-EU-Q16)	health literacy: 16 items, min 16, max 64, higher scores indicating lower health literacy	twelve months
Other	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)
Other	Brief Illnness Perception Questionnaire (BIPQ)	individual concept of illness; 8 items, min 0, max 80, higher scores indicating worse illness perception	twelve months
Other	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)
Other	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
Other	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
Other	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)
Other	Patient Health Questionnaire-9 (PHQ-9)	depressive symptoms; 9 items, min 0, max 27, higher scores indicating higher depressive symptoms	three months
Other	Patient Health Questionnaire-9 (PHQ-9)	depressive symptoms; 9 items, min 0, max 27, higher scores indicating higher depressive symptoms	twelve months
Other	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)
Other	Generalized Anxiety Disorder-2 (GAD-2)	anxiety symptoms; 2 items, min 0, max 6, higher scores indicating higher anxiety symptoms	three months
Other	Generalized Anxiety Disorder-2 (GAD-2)	anxiety symptoms; 2 items, min 0, max 6, higher scores indicating higher anxiety symptoms	twelve months
Other	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)
Other	Cardiac Anxiety Questionnaire (CAQ)	cardiac anxiety; 17 items, min 0, max 68, higher scores indicating higher cardiac anxiety	three months
Other	Cardiac Anxiety Questionnaire (CAQ)	cardiac anxiety; 17 items, min 0, max 68, higher scores indicating higher cardiac anxiety	twelve months
Other	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)
Other	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)
Other	Somatic Symptom Scale-8 (SSS-8)	somatic symptom burden; 8 items, min 0, max 32, higher scores indicating higher somatic symptom burden	three months
Other	Somatic Symptom Scale-8 (SSS-8)	somatic symptom burden; 8 items, min 0, max 32, higher scores indicating higher somatic symptom burden	twelve months
Other	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)
Other	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
Other	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
Other	International Physical Activity Questionnaire Short Form (IPAQ)	level of physical activity	day of discharge (approx. 5 - 10 days after operation)
Other	International Physical Activity Questionnaire Short Form (IPAQ)	level of physical activity	twelve months
Other	Hand Dynamometer	hand grip strength	day of discharge (approx. 5 - 10 days after operation)
Other	Hand Dynamometer	hand grip strength	twelve months
Other	1 Minute Sit to Stand Test (1STS)	physical capacity expressed with the number of repetitions	day of discharge (approx. 5 - 10 days after operation)
Other	1 Minute Sit to Stand Test (1STS)	physical capacity expressed with the number of repetitions	twelve months
Other	Timed Up and Go (TUG)	physical capacity expressed with the duration in seconds	day of discharge (approx. 5 - 10 days after operation)
Other	Timed Up and Go (TUG)	physical capacity expressed with the duration in seconds	twelve months
Other	Six Minute Walk Test	physical capacity expressed with the walking distance in meters	twelve months
Other	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)
Other	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)
Other	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
Other	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
Other	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
Primary	Hospitalization	number of hospitalized days due to cardiac reasons	twelve months
Primary	Six Minute Walk Test	physical capacity expressed with the walking distance in meters	day of discharge (approx. 5 - 10 days after operation)
Secondary	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
Secondary	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
Secondary	HeartQoL	health-related quality of life; 14 items, min 0, max 42, higher scores indicating better health-related quality of life	three months
Secondary	HeartQoL	health-related quality of life; 14 items, min 0, max 42, higher scores indicating better health-related quality of life	twelve months
Secondary	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

External Links

•   summary of the project on the sponsor's website