Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Heart Surgery | Study protocol

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

Authors: Susanne G. R. Klotz, Gesche Ketels, Christian A. Behrendt, Hans-Helmut König, Sebastian Kohlmann, Bernd Löwe, Johannes Petersen, Sina Stock, Eik Vettorazzi, Antonia Zapf, Inke Zastrow, Christian Zöllner, Hermann Reichenspurner, Evaldas Girdauskas

Published in: Trials | Issue 1/2022

Login to get access

Abstract

Background

Valvular heart diseases are frequent and increasing in prevalence. Minimally invasive heart valve surgery embedded in an interdisciplinary enhanced recovery after surgery (ERAS) program may have potential benefits with regard to reduced length of stay and improved patient reported outcomes. However, no prospective randomized data exist regarding the superiority of ERAS program for the patients’ outcome.

Methods

We aim to randomize (1:1) a total of 186 eligible patients with minimally invasive heart valve surgery to an ERAS program vs. standard treatment at two centers including the University Medical Center Hamburg-Eppendorf, Germany, and the University Hospital Augsburg, Germany. The intervention is composed out of pre-, peri-, and postoperative components. The preoperative protocol aims at better preparation for the operation with regard to physical activity, nutrition, and psychological preparedness. Intraoperative anesthesiologic and surgical management are trimmed to enable an early extubation. Patients will be transferred to a specialized postoperative anesthesia care unit, where first mobilization occurs 3 h after surgery. Transfer to low care ward will be at the next day and discharge at the fifth day. Participants in the control group will receive treatment as usual. Primary endpoints include functional discharge at discharge and duration of in-hospital care during the first 12 months after index surgery. Secondary outcomes include health-related quality of life, health literacy, and level of physical activity.

Discussion

This is the first randomized controlled trial evaluating the effectiveness of an ERAS process after minimally invasive heart valve surgery. Interprofessional approach is the key factor of the ERAS process and includes in particular surgical, anesthesiological, physiotherapeutic, advanced nursing, and psychosocial components. A clinical implication guideline will be developed facilitating the adoption of ERAS model in other heart teams.

Trial registration

The study has been registered in ClinicalTrials.gov (NCT04977362 assigned July 27, 2021).
Literature
1.
Shipton B, Wahba H. Valvular heart disease: review and update. Am Fam Physician. 2001;63(11):2201–8.PubMed
2.
Coffey S, Roberts-Thomson R, Brown A, Carapetis J, Chen M, Enriquez-Sarano M, et al. Global epidemiology of valvular heart disease. Nat Rev Cardiol. 2021;18(12):853–64.PubMedCrossRef
3.
Beckmann A, Meyer R, Lewandowski J, Markewitz A, Gummert J. German Heart Surgery Report 2020: the annual updated registry of the German Society for Thoracic and Cardiovascular Surgery. Thorac Cardiovasc Surg. 2021;69(4):294–307.PubMedCrossRef
4.
5.
Nakajima M, Totsugawa T, Sakaguchi T, Yuguchi S, Matsuo T, Ujikawa T, et al. Changes in the amount of physical activity in minimally invasive cardiac surgery. J Phys Ther Sci. 2017;29(11):2035–8.PubMedPubMedCentralCrossRef
6.
Abeles A, Kwasnicki RM, Pettengell C, Murphy J, Darzi A. The relationship between physical activity and post-operative length of hospital stay: a systematic review. Int J Surg. 2017;44:295–302.PubMedCrossRef
7.
Chen J, Zhang T, Bao W, Zhao G, Chen Z. The effect of in-hospital physiotherapy on handgrip strength and physical activity levels after cardiac valve surgery: a randomized controlled trial. Ann Palliat Med. 2021;10(2):2217–23.PubMedCrossRef
8.
Auer CJ, Laferton JAC, Shedden-Mora MC, Salzmann S, Moosdorf R, Rief W. Optimizing preoperative expectations leads to a shorter length of hospital stay in CABG patients: further results of the randomized controlled PSY-HEART trial. J Psychosom Res. 2017;97:82–9.PubMedCrossRef
9.
Rief W, Shedden-Mora MC, Laferton JA, Auer C, Petrie KJ, Salzmann S, et al. Preoperative optimization of patient expectations improves long-term outcome in heart surgery patients: results of the randomized controlled PSY-HEART trial. BMC Med. 2017;15(1):4.PubMedPubMedCentralCrossRef
10.
Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: a review. JAMA Surg. 2017;152(3):292–8.PubMedCrossRef
11.
Baxter R, Squiers J, Conner W, Kent M, Fann J, Lobdell K, et al. Enhanced Recovery After Surgery: a narrative review of its application in cardiac surgery. Ann Thorac Surg. 2020;109(6):1937–44.PubMedCrossRef
12.
Kamal YA, Hassanein A. Do perioperative protocols of enhanced recovery after cardiac surgery improve postoperative outcome? Interact Cardiovasc Thorac Surg. 2020;30(5):706–10.PubMedCrossRef
13.
Zaouter C, Oses P, Assatourian S, Labrousse L, Rémy A, Ouattara A. Reduced length of hospital stay for cardiac surgery-implementing an optimized perioperative pathway: prospective evaluation of an Enhanced Recovery After Surgery program designed for mini-invasive aortic valve replacement. J Cardiothorac Vasc Anesth. 2019;33(11):3010–9.PubMedCrossRef
14.
Kubitz JC, Schulte-Uentrop L, Zoellner C, Lemke M, Messner-Schmitt A, Kalbacher D, et al. Establishment of an enhanced recovery after surgery protocol in minimally invasive heart valve surgery. PLoS One. 2020;15(4):e0231378.PubMedPubMedCentralCrossRef
15.
Petersen J, Kloth B, Konertz J, Kubitz J, Schulte-Uentrop L, Ketels G, et al. Economic impact of enhanced recovery after surgery protocol in minimally invasive cardiac surgery. BMC Health Serv Res. 2021;21(1):254.PubMedPubMedCentralCrossRef
16.
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7.PubMedPubMedCentralCrossRef
17.
World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310(20):2191–4.CrossRef
18.
Dapp U, Anders J, Golgert S, von Renteln-Kruse W, Minder CE. Ressourcen und Risiken im Alter. Die LUCAS-I Marker zur Klassifizierung älterer Menschen als FIT, pre-FRAIL und FRAIL. Validierung und erste Ergebnisse aus der Longitudinalen Urbanen Cohorten-Alters-Studie (LUCAS). Z Gerontol Geriat. 2012;45(4):262–70.CrossRef
19.
Fiorina C, Vizzardi E, Lorusso R, Maggio M, De Cicco G, Nodari S, et al. The 6-min walking test early after cardiac surgery. reference values and the effects of rehabilitation programme. Eur J Cardiothorac Surg. 2007;32(5):724–9.PubMedCrossRef
20.
Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, et al. Guidelines for perioperative care in cardiac surgery: Enhanced Recovery After Surgery Society recommendations. JAMA Surg. 2019;154(8):755–66.PubMedCrossRef
21.
Miller WR, Rollnick S. Motivierende Gesprächsführung Motivational Interviewing. Freiburg: Lambertus; 2015.
22.
Salzmann S, Laferton J, Auer C, Shedden-Mora M, Wambach K, Rief W. Patientenerwartungen optimieren: Beschreibung einer präoperativen Kurzintervention am Beispiel von Patienten vor einer Bypass-Operation. Verhaltenstherapie 2018;28:157–65. https://​doi.​org/​10.​1159/​000485430.
23.
24.
American Thoracic Society. ATS Statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002;166(1):111–7.CrossRef
25.
Kiresuk TJ, Sherman RE. Goal attainment scaling: a general method for evaluating comprehensive community mental health programs. Community Ment Health J. 1968;4(6):443–53.PubMedCrossRef
26.
Huber A, Oldridge N, Benzer W, Saner H, Höfer S. Validation of the German HeartQoL: a short health-related quality of life questionnaire for cardiac patients. Qual Life Res. 2020;29(4):1093–105.PubMedCrossRef
27.
Oldridge N, Höfer S, McGee H, Conroy R, Doyle F, Saner H. The HeartQoL: Part I. Development of a new core health-related quality of life questionnaire for patients with ischemic heart disease. Eur J Prev Cardiol. 2014;21(1):90–7.PubMedCrossRef
28.
29.
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727–36.PubMedPubMedCentralCrossRef
30.
Timmermans I, Versteeg H, Meine M, Pedersen SS, Denollet J. Illness perceptions in patients with heart failure and an implantable cardioverter defibrillator: dimensional structure, validity, and correlates of the brief illness perception questionnaire in Dutch, French and German patients. J Psychosom Res. 2017;97:1–8.PubMedCrossRef
31.
Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006;60(6):631–7.PubMedCrossRef
32.
Gierk B, Kohlmann S, Kroenke K, Spangenberg L, Zenger M, Brähler E, et al. The somatic symptom scale-8 (SSS-8): a brief measure of somatic symptom burden. JAMA Intern Med. 2014;174(3):399–407.PubMedCrossRef
33.
Toussaint A, Murray AM, Voigt K, Herzog A, Gierk B, Kroenke K, et al. Development and validation of the Somatic Symptom Disorder-B Criteria Scale (SSD-12). Psychosom Med. 2016;78(1):5–12.PubMedCrossRef
34.
Hoyer J, Eifert GH. Herzangstfragebogen (HAF-17) – überarbeitete deutsche Version. Dresden: Technische Universität; 2004.
35.
Eifert GH, Thompson RN, Zvolensky MJ, Edwards K, Frazer NL, Haddad JW, et al. The cardiac anxiety questionnaire: development and preliminary validity. Behav Res Ther. 2000;38(10):1039–53.PubMedCrossRef
36.
Löwe B, Kroenke K, Herzog W, Gräfe K. Measuring depression outcome with a brief self-report instrument: sensitivity to change of the Patient Health Questionnaire (PHQ-9). J Affect Disord. 2004;81(1):61–6.PubMedCrossRef
37.
Kroenke K, Spitzer RL, Williams JB, Monahan PO, Löwe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007;146(5):317–25.PubMedCrossRef
38.
Glaesmer H, Hoyer J, Klotsche J, Herzberg PY. Die deutsche Version des Life-Orientation-Tests (LOT-R) zum dispositionellen Optimismus und Pessimismus. Zeitschrift für Gesundheitspsychologie. 2008;16(1):26–31.CrossRef
39.
Scheier MF, Carver CS, Bridges MW. Distinguishing optimism from neuroticism (and trait anxiety, self-mastery, and self-esteem): a reevaluation of the Life Orientation Test. J Pers Soc Psychol. 1994;67(6):1063–78.PubMedCrossRef
40.
Mäder U, Martin BW, Schutz Y, Marti B. Validity of four short physical activity questionnaires in middle-aged persons. Med Sci Sports Exerc. 2006;38(7):1255–66.PubMedCrossRef
41.
Craig CL, Marshall AL, Sjöström M, Bauman AE, Booth ML, Ainsworth BE, et al. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003;35(8):1381–95.PubMedCrossRef
42.
Podsiadlo D, Richardson S. The timed “Up & Go”: a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991;39(2):142–8.PubMedCrossRef
43.
Bohannon RW, Crouch R. 1-minute sit-to-stand test: systematic review of procedures, performance, and clinimetric properties. J Cardiopulm Rehabil Prev. 2019;39(1):2–8.PubMedCrossRef
44.
Bohannon RW. Muscle strength: clinical and prognostic value of hand-grip dynamometry. Curr Opin Clin Nutr Metab Care. 2015;18(5):465–70.PubMedCrossRef
45.
Röthlin F, Pelikan JM, Ganahl K. Die Gesundheitskompetenz der 15-jährigen Jugendlichen in Österreich. Abschlussbericht der österreichischen Gesundheitskompetenz Jugendstudie im Auftrag des Hauptverbands der österreichischen Sozialversicherungsträger (HVSV). Wien: Ludwig Boltzmann Institut Health Promotion Research (LBIHPR); 2013.
46.
Alberts J, Löwe B, Glahn MA, Petrie K, Laferton J, Nestoriuc Y, et al. Development of the generic, multidimensional Treatment Expectation Questionnaire (TEX-Q) through systematic literature review, expert surveys and qualitative interviews. BMJ Open. 2020;10(8):e036169.PubMedPubMedCentralCrossRef
47.
Kleinknecht-Dolf M, Lendner I, Müller R, Horlacher K, Martin JS, Spirig R. Einschätzung der Austrittsbereitschaft von Patienten in akutsomatischen Spitälern in der Schweiz durch Pflegefachpersonen: Eine Pilotstudie und Querschnittserhebung mit der deutschsprachigen Übersetzung der Kurzform der “Readiness for Hospital Discharge Scale”. Pflegewissenschaft. 2019;21(1/2):30–40.
48.
Weiss ME, Costa LL, Yakusheva O, Bobay KL. Validation of patient and nurse short forms of the Readiness for Hospital Discharge Scale and their relationship to return to the hospital. Health Serv Res. 2014;49(1):304–17.PubMedCrossRef
49.
Seidl H, Bowles D, Bock JO, Brettschneider C, Greiner W, König HH, et al. FIMA – Fragebogen zur Erhebung von Gesundheitsleistungen im Alter: Entwicklung und Pilotstudie. Gesundheitswesen. 2015;77(01):46–52.PubMed
50.
Coleman SR, Chen M, Patel S, Yan H, Kaye AD, Zebrower M, et al. Enhanced recovery pathways for cardiac surgery. Curr Pain Headache Rep. 2019;23(4):28.PubMedCrossRef
51.
Maj G, Regesta T, Campanella A, Cavozza C, Parodi G, Audo A. Optimal management of patients treated with minimally invasive cardiac surgery in the era of Enhanced Recovery After Surgery and fast-track protocols: a narrative review. J Cardiothorac Vasc Anesth. 2022;36(3):766–75.PubMedCrossRef
52.
Bouhout I, Morgant MC, Bouchard D. Minimally invasive heart valve surgery. Can J Cardiol. 2017;33(9):1129–37.PubMedCrossRef
53.
Yadgir S, Johnson CO, Aboyans V, Adebayo OM, Adedoyin RA, Afarideh M, et al. Global, regional, and national burden of calcific aortic valve and degenerative mitral valve diseases, 1990-2017. Circulation. 2020;141(21):1670–80.PubMedCrossRef
54.
Li Y, Yan C, Li J, Wang Q, Zhang J, Qiang W, et al. A nurse-driven enhanced recovery after surgery (ERAS) nursing program for geriatric patients following lung surgery. Thorac Cancer. 2020;11(4):1105–13.PubMedPubMedCentralCrossRef
55.
Khandhar SJ, Schatz CL, Collins DT, Graling PR, Rosner CM, Mahajan AK, et al. Thoracic enhanced recovery with ambulation after surgery: a 6-year experience. Eur J Cardiothorac Surg. 2018;53(6):1192–8.PubMedCrossRef
56.
Mayor MA, Khandhar SJ, Chandy J, Fernando HC. Implementing a thoracic enhanced recovery with ambulation after surgery program: key aspects and challenges. J Thorac Dis. 2018;10(Suppl 32):S3809–s14.PubMedPubMedCentralCrossRef
57.
Mackay MR, Ellis E, Johnston C. Randomised clinical trial of physiotherapy after open abdominal surgery in high risk patients. Aust J Physiother. 2005;51(3):151–9.PubMedCrossRef
58.
Silva YR, Li SK, Rickard MJ. Does the addition of deep breathing exercises to physiotherapy-directed early mobilisation alter patient outcomes following high-risk open upper abdominal surgery? Cluster randomised controlled trial. Physiotherapy. 2013;99(3):187–93.PubMedCrossRef
59.
Svensson-Raskh A, Schandl AR, Ståhle A, Nygren-Bonnier M, Fagevik Olsén M. Mobilization started within 2 hours after abdominal surgery improves peripheral and arterial oxygenation: a single-center randomized controlled trial. Phys Ther. 2021;101(5):pzab094.PubMedPubMedCentralCrossRef
60.
Epton T, Currie S, Armitage CJ. Unique effects of setting goals on behavior change: systematic review and meta-analysis. J Consult Clin Psychol. 2017;85(12):1182–98.PubMedCrossRef
61.
Probst S, Cech C, Haentschel D, Scholz M, Ender J. A specialized post anaesthetic care unit improves fast-track management in cardiac surgery: a prospective randomized trial. Crit Care. 2014;18(4):468.PubMedPubMedCentralCrossRef
Metadata
Title
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
Authors
Susanne G. R. Klotz
Gesche Ketels
Christian A. Behrendt
Hans-Helmut König
Sebastian Kohlmann
Bernd Löwe
Johannes Petersen
Sina Stock
Eik Vettorazzi
Antonia Zapf
Inke Zastrow
Christian Zöllner
Hermann Reichenspurner
Evaldas Girdauskas
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06455-x

Other articles of this Issue 1/2022

Trials 1/2022 Go to the issue

Study protocol

Analgesic effect of auricular point acupressure for acute pain in patients with dementia: study protocol for a randomized controlled trial

Study protocol

The haemostatic effect of deep-frozen platelets versus room temperature-stored platelets in the treatment of surgical bleeding: MAFOD—study protocol for a randomized controlled non-inferiority trial

Study protocol

The CHALLENGE trial: the effects of a virtual reality-assisted exposure therapy for persistent auditory hallucinations versus supportive counselling in people with psychosis: study protocol for a randomised clinical trial

Study protocol

Effects of traditional Chinese medicine collaborative model (TCMCM) combined with adjuvant chemotherapy on IIIb and IIIc gastric cancer: a protocol for a randomized controlled trial

Study protocol

Does closed-loop automated oxygen control reduce the duration of mechanical ventilation? A randomised controlled trial in ventilated preterm infants

Study protocol

Study in Parkinson’s disease of exercise phase 3 (SPARX3): study protocol for a randomized controlled trial