Susanne G. R. Klotz
Current Organizations / Institutes
The organizations/institutes from the scholar's latest article
Previous Organizations / Institutes
The organizations / institutes from the scholar's other articles in the past ten years
Research Subjects
Research Interests
Susanne G. R. Klotz has a total of 87 co-authors. Here are the top co-authors by number of shared publications:
Gesche Ketels
University Medical Center Hamburg-Eppendorf
7 shared publications- Bernd Löwe
Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
4 shared publications Bernd Löwe
University Medical Center Hamburg-Eppendorf: Universitatsklinikum Hamburg-Eppendorf
3 shared publications- Evaldas Girdauskas
Department of Cardiac Surgery, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, Hamburg, 20246, Germany
3 shared publications Anne Barzel
Universitätsklinikum Hamburg-Eppendorf, Institut und Poliklinik für Allgemeinmedizin
2 shared publications- Antonia Zapf
Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
2 shared publications
Latest Publications
- Open Access
- 31 January 2026
- Published by Oxford University Press (OUP) in European Journal of Cardio-Thoracic Surgery
- Vol. 68 (2)
Interdisciplinary and Cross-Sectoral Perioperative Care Model in Cardiac Surgery: ERAS Implementation in the Setting of Minimally Invasive Heart Valve Surgery (INCREASE)—Results of a Randomized Controlled Trial
Objectives: Enhanced recovery after surgery (ERAS) protocols are patient-centred, interprofessional perioperative care models aimed at reducing hospital stays, complications, healthcare costs, and improving patient satisfaction. Evidence for ERAS in cardiac surgery is scarce; therefore, we aimed to assess its efficacy and safety in minimally invasive heart valve surgery (MIHS). Methods: Interdisciplinary Perioperative Care in Minimally Invasive Heart Valve Surgery (INCREASE) is a randomized-controlled trial that compares ERAS with standard care in MIHS. The intervention group (IG) received ERAS-based treatment; the control group (CG) standard care. Co-primary end-points were in-hospital stay for cardiovascular reasons within 1 year postoperatively (superiority hypothesis) and physical performance (6-minute walk test [6MWT]) at discharge (non-inferiority hypothesis). Superiority hypothesis was tested primarily in surgically treated patients (modified intention to treat population), while non-inferiority hypothesis was tested in per protocol population. Results: In total, 201 patients scheduled for MIHS were randomized (IG: 101; CG: 100). Total weighted in-hospital stay within 1 year was non-significantly shorter in the IG (adjusted mean difference −2.7 days, 95% confidence interval (CI) (−6.3, 0.9), 1-sided P = .07). Sensitivity analyses favoured the IG (adjusted ratio 0.71, 95% CI, 0.6, 0.85). For 6MWT, adjusted mean difference was −14%, 95% CI (−43%, 15%) exceeding the non-inferiority margin of −15% (1-sided P = .48). Without baseline adjustment, 6MWT values revealed a mean difference between groups of −1%, 95% CI (−10%, 8%), reaching non-inferiority of the IG. Safety outcomes were comparable with the exception of an unexpected higher rate of post-operative atrial fibrillation in patients randomized to ERAS. Conclusions: ERAS is feasible and safe in MIHS. The trial did not demonstrate a reduction in length of hospital stay during the first postoperative year in the population studied. Exploratory analyses suggest that further evaluation of ERAS concepts is justified.
- 31 January 2026
- Published by Oxford University Press (OUP) in European Journal of Cardio-Thoracic Surgery
- Vol. 68 (2)
Open AccessInterdisciplinary and Cross-Sectoral Perioperative Care Model in Cardiac Surgery: ERAS Implementation in the Setting of Minimally Invasive Heart Valve Surgery (INCREASE)—Results of a Randomized Controlled Trial
Objectives: Enhanced recovery after surgery (ERAS) protocols are patient-centred, interprofessional perioperative care models aimed at reducing hospital stays, complications, healthcare costs, and improving patient satisfaction. Evidence for ERAS in cardiac surgery is scarce; therefore, we aimed to assess its efficacy and safety in minimally invasive heart valve surgery (MIHS). Methods: Interdisciplinary Perioperative Care in Minimally Invasive Heart Valve Surgery (INCREASE) is a randomized-controlled trial that compares ERAS with standard care in MIHS. The intervention group (IG) received ERAS-based treatment; the control group (CG) standard care. Co-primary end-points were in-hospital stay for cardiovascular reasons within 1 year postoperatively (superiority hypothesis) and physical performance (6-minute walk test [6MWT]) at discharge (non-inferiority hypothesis). Superiority hypothesis was tested primarily in surgically treated patients (modified intention to treat population), while non-inferiority hypothesis was tested in per protocol population. Results: In total, 201 patients scheduled for MIHS were randomized (IG: 101; CG: 100). Total weighted in-hospital stay within 1 year was non-significantly shorter in the IG (adjusted mean difference −2.7 days, 95% confidence interval (CI) (−6.3, 0.9), 1-sided P = .07). Sensitivity analyses favoured the IG (adjusted ratio 0.71, 95% CI, 0.6, 0.85). For 6MWT, adjusted mean difference was −14%, 95% CI (−43%, 15%) exceeding the non-inferiority margin of −15% (1-sided P = .48). Without baseline adjustment, 6MWT values revealed a mean difference between groups of −1%, 95% CI (−10%, 8%), reaching non-inferiority of the IG. Safety outcomes were comparable with the exception of an unexpected higher rate of post-operative atrial fibrillation in patients randomized to ERAS. Conclusions: ERAS is feasible and safe in MIHS. The trial did not demonstrate a reduction in length of hospital stay during the first postoperative year in the population studied. Exploratory analyses suggest that further evaluation of ERAS concepts is justified.
- Open Access
- 11 March 2025
- Published by SAGE Publications in Clinical Rehabilitation
- Vol. 39 (5) , 668-678
Facilitators and barriers to physical activity in patients in an acute care hospital setting from an interprofessional perspective: A qualitative study
Objective: Physical activity levels of patients in hospital are low. The aim of this study was to explore the perceptions of physiotherapists, nurses, and physicians about physical activity of hospitalized patients. Design: Qualitative focus group study using phenomenology. Setting: University hospital. Participants: Thirty healthcare professionals (physiotherapists, nurses, and physicians) participated in six focus groups. Main measures: Semi-structured focus groups following an interview guide were conducted. Besides identification of influencing factors and development of ideas for associated interventions, participants should reflect on the roles of different professions. Content analysis of the transcriptions was performed in iterative cycles involving three researchers using inductive coding and redefining based on the literature. Consensus was reached through discussions in the research team. Results: Three themes of influencing factors on physical activity of patients in hospital with seven codes emerged. In the theme “patient” physical and psychosocial factors were mentioned. The theme “organization” pooled all factors regarding facilities and processes. The third theme “health literacy” has an impact on the two other themes. In this theme self-efficacy, handling of health literacy/knowledge, and communication and cooperation became apparent as codes. Conclusions: Health literacy plays an important role in the physical activity of patients in hospital. The developed model of influencing factors on physical activity highlights the importance of health literacy for all stakeholders, including patients, staff, and the organization and illustrates the connections to other influencing factors. This model can be helpful in conceptualizing interventions to promote physical activity.
- 11 March 2025
- Published by SAGE Publications in Clinical Rehabilitation
- Vol. 39 (5) , 668-678
Open AccessFacilitators and barriers to physical activity in patients in an acute care hospital setting from an interprofessional perspective: A qualitative study
Objective: Physical activity levels of patients in hospital are low. The aim of this study was to explore the perceptions of physiotherapists, nurses, and physicians about physical activity of hospitalized patients. Design: Qualitative focus group study using phenomenology. Setting: University hospital. Participants: Thirty healthcare professionals (physiotherapists, nurses, and physicians) participated in six focus groups. Main measures: Semi-structured focus groups following an interview guide were conducted. Besides identification of influencing factors and development of ideas for associated interventions, participants should reflect on the roles of different professions. Content analysis of the transcriptions was performed in iterative cycles involving three researchers using inductive coding and redefining based on the literature. Consensus was reached through discussions in the research team. Results: Three themes of influencing factors on physical activity of patients in hospital with seven codes emerged. In the theme “patient” physical and psychosocial factors were mentioned. The theme “organization” pooled all factors regarding facilities and processes. The third theme “health literacy” has an impact on the two other themes. In this theme self-efficacy, handling of health literacy/knowledge, and communication and cooperation became apparent as codes. Conclusions: Health literacy plays an important role in the physical activity of patients in hospital. The developed model of influencing factors on physical activity highlights the importance of health literacy for all stakeholders, including patients, staff, and the organization and illustrates the connections to other influencing factors. This model can be helpful in conceptualizing interventions to promote physical activity.
- Open Access
- 9 January 2025
- Published by Wiley in Physiotherapy Research International
- Vol. 30 (1) , e70024
Facilitators and Barriers for Physiotherapists to Engage in Goal‐Setting With Patients During Their Hospital Stay—An Explanatory Sequential Mixed‐Methods Study
Background and Purpose: Goal setting is a key aspect of patient‐centered physiotherapy, helping to motivate patients, align healthcare efforts, prevent oversight, and stop ineffective interventions. This study aims to identify facilitators and barriers for physiotherapists in hospitals to set and document patient treatment goals.Methods: An explanatory sequential mixed‐methods approach was used. The survey, informed by systematic reviews of factors influencing shared decision‐making and the theoretical domains framework (TDF), included 25 statements to be rated. Two focus groups (n = 8) discussed (1) factors from the survey, (2) the goal‐setting processes, and (3) brainstormed facilitators and barriers for documenting physiotherapy goals.Results: Survey findings showed mixed opinions but agreement on two factors, which indicate that the goal influences the therapeutic interventions and motivates the therapists. The focus group identified four themes: “Goal,” “Physiotherapeutic Self‐Conception,” “Interprofessionality”, and “Hospital Setting.” Issues included limited space and poor placement in documentation systems, mental rather than written goal conceptualization, and a perceived lack of interest from interprofessional team members, leading to deprioritization by physiotherapists. Finally, joint goal setting was deemed impractical for certain patients.Discussion: Hospital physiotherapists set treatment goals with their patients. The process is influenced by various factors, including interprofessional dynamics and the hospital setting. The identified themes align with existing literature. Effective documentation of patient‐centered physiotherapy goals in hospitals requires well‐designed tools and interprofessional collaboration. Further, it is crucial to understand professional self‐conception and acknowledge situations where physiotherapists need to set goals independently.
- 9 January 2025
- Published by Wiley in Physiotherapy Research International
- Vol. 30 (1) , e70024
Open AccessFacilitators and Barriers for Physiotherapists to Engage in Goal‐Setting With Patients During Their Hospital Stay—An Explanatory Sequential Mixed‐Methods Study
Background and Purpose: Goal setting is a key aspect of patient‐centered physiotherapy, helping to motivate patients, align healthcare efforts, prevent oversight, and stop ineffective interventions. This study aims to identify facilitators and barriers for physiotherapists in hospitals to set and document patient treatment goals.Methods: An explanatory sequential mixed‐methods approach was used. The survey, informed by systematic reviews of factors influencing shared decision‐making and the theoretical domains framework (TDF), included 25 statements to be rated. Two focus groups (n = 8) discussed (1) factors from the survey, (2) the goal‐setting processes, and (3) brainstormed facilitators and barriers for documenting physiotherapy goals.Results: Survey findings showed mixed opinions but agreement on two factors, which indicate that the goal influences the therapeutic interventions and motivates the therapists. The focus group identified four themes: “Goal,” “Physiotherapeutic Self‐Conception,” “Interprofessionality”, and “Hospital Setting.” Issues included limited space and poor placement in documentation systems, mental rather than written goal conceptualization, and a perceived lack of interest from interprofessional team members, leading to deprioritization by physiotherapists. Finally, joint goal setting was deemed impractical for certain patients.Discussion: Hospital physiotherapists set treatment goals with their patients. The process is influenced by various factors, including interprofessional dynamics and the hospital setting. The identified themes align with existing literature. Effective documentation of patient‐centered physiotherapy goals in hospitals requires well‐designed tools and interprofessional collaboration. Further, it is crucial to understand professional self‐conception and acknowledge situations where physiotherapists need to set goals independently.
- Open Access
- 25 December 2024
- Published by Oxford University Press (OUP) in Interdisciplinary CardioVascular and Thoracic Surgery
- Vol. 40 (1)
Development of a core outcome set of quality indicators for enhanced recovery after surgery in minimally invasive cardiac heart valve surgery by interprofessional Delphi consensus
OBJECTIVES: A core outcome set (COS) giving indicators of the quality of the process for minimally invasive valve surgery embedded into enhanced recovery after surgery (ERAS) protocols should be developed. METHODS: Using web-based questionnaires, a Delphi process with three rounds was conducted from January to December 2022. Prior to the rounds, a systematic database search was performed identifying potential quality parameters. Experts for the panel were selected reflecting the interprofessional nature of the ERAS protocol. In the first round, participants could make suggestions of indicators in the pre-, intra- or postoperative and rehabilitative phase. These suggestions form together with the indicators of the literature a first indicator list. In the second round, participants could rate the relevance of the indicators resulting in a condensed indicator list. The third round was performed for further condensation based on importance ranking of the remaining indicators. RESULTS: Three studies could be included in the systematic literature search providing a list of 22 indicators. Twenty-one experts participated in the Delphi survey. The experts named 315 indicators in the first round. After condensation in two further rounds, the final COS consisted of 24 indicators in the categories structure, process, outcome and complications. CONCLUSIONS: A consensual minimum set of quality measurements during pre-, intra- and postoperative and rehabilitation phase for patients with minimally invasive heart surgery is now available for enhancing the quality of clinical practice and facilitating comparisons across different ERAS programs.
- 25 December 2024
- Published by Oxford University Press (OUP) in Interdisciplinary CardioVascular and Thoracic Surgery
- Vol. 40 (1)
Open AccessDevelopment of a core outcome set of quality indicators for enhanced recovery after surgery in minimally invasive cardiac heart valve surgery by interprofessional Delphi consensus
OBJECTIVES: A core outcome set (COS) giving indicators of the quality of the process for minimally invasive valve surgery embedded into enhanced recovery after surgery (ERAS) protocols should be developed. METHODS: Using web-based questionnaires, a Delphi process with three rounds was conducted from January to December 2022. Prior to the rounds, a systematic database search was performed identifying potential quality parameters. Experts for the panel were selected reflecting the interprofessional nature of the ERAS protocol. In the first round, participants could make suggestions of indicators in the pre-, intra- or postoperative and rehabilitative phase. These suggestions form together with the indicators of the literature a first indicator list. In the second round, participants could rate the relevance of the indicators resulting in a condensed indicator list. The third round was performed for further condensation based on importance ranking of the remaining indicators. RESULTS: Three studies could be included in the systematic literature search providing a list of 22 indicators. Twenty-one experts participated in the Delphi survey. The experts named 315 indicators in the first round. After condensation in two further rounds, the final COS consisted of 24 indicators in the categories structure, process, outcome and complications. CONCLUSIONS: A consensual minimum set of quality measurements during pre-, intra- and postoperative and rehabilitation phase for patients with minimally invasive heart surgery is now available for enhancing the quality of clinical practice and facilitating comparisons across different ERAS programs.
- Open Access
- 27 May 2024
- Vol. 22, Doc06
Position statement on genuine physiotherapy research at German university hospitals
In addition to patient care, physiotherapy is increasingly important in research at university hospitals. Genuine physiotherapy research plays a decisive role in this. This position statement describes the opportunities, benefits, framework conditions, challenges, and research priorities of genuine physiotherapy research at German university hospitals.
- 27 May 2024
- Vol. 22, Doc06
Open AccessPosition statement on genuine physiotherapy research at German university hospitals
In addition to patient care, physiotherapy is increasingly important in research at university hospitals. Genuine physiotherapy research plays a decisive role in this. This position statement describes the opportunities, benefits, framework conditions, challenges, and research priorities of genuine physiotherapy research at German university hospitals.
- Open Access
- 14 November 2023
- Published by Wiley in Acta Obstetricia et Gynecologica Scandinavica
- Vol. 103 (2) , 199-209
The role of psychosocial factors in the interprofessional management of women with chronic pelvic pain: A systematic review
Introduction: Chronic pelvic pain (CPP) is a common pain disorder in women associated with negative biopsychosocial consequences. The multifactorial etiology and maintaining aspects of CPP logically require an interprofessional treatment approach. However, the effects of interprofessional treatment strategies on psychosocial factors remain unclear. The study aims to investigate how interprofessional therapy helps to treat psychosocial factors in women with CPP. The systematic review summarizes the current evidence of interprofessional treatment in women with CPP.Material and methods: A systematic literature review was performed in six databases (Medline, Web of Science, Cochrane Library, PEDro, CINAHL, and PsycINFO) until February 2023. Studies were selected in a two‐step approach applying as inclusion criteria the search combinations of Chronic Pelvic Pain and CPP, synonyms for interprofessional therapies, and for female patients. Studies were excluded if they were not quantitative primary research published in English, if CPP was not defined appropriately, if the study population was not female adult patients, if the interprofessional intervention was not operationalized appropriately, if they were single case studies, and if outcomes did not include at least one of the psychosocial factors pain, depressive symptoms, pain catastrophizing, fear, or anxiety. Risk of bias of the included studies was rated with the McMaster Critical Review Form. Studies were summarized narratively. The review is registered in PROSPERO (CRD42023391008).Results: Five studies with a total sample size of n = 186 women were included, three of them were uncontrolled retrospective before‐after chart review. Only one study used a randomized controlled design, the other study used a non‐randomized controlled group. The studies' methodological quality is adequate with perspective of study design. The multiprofessional treatment approaches used in the studies differed with regard to professions involved, therapy methods, and modalities. Psychosocial outcome measures were pain (five studies), depressive symptoms (three studies), and anxiety symptoms (four studies).Conclusions: Although interprofessional treatment strategies for women with CPP are recommended in existing guidelines, available evidence is scarce and does not allow for identification of the best interprofessional treatment approach. The effect on psychosocial factors remains unclear. More research is needed determining the best practice interprofessional treatment option for women with CPP.
- 14 November 2023
- Published by Wiley in Acta Obstetricia et Gynecologica Scandinavica
- Vol. 103 (2) , 199-209
Open AccessThe role of psychosocial factors in the interprofessional management of women with chronic pelvic pain: A systematic review
Introduction: Chronic pelvic pain (CPP) is a common pain disorder in women associated with negative biopsychosocial consequences. The multifactorial etiology and maintaining aspects of CPP logically require an interprofessional treatment approach. However, the effects of interprofessional treatment strategies on psychosocial factors remain unclear. The study aims to investigate how interprofessional therapy helps to treat psychosocial factors in women with CPP. The systematic review summarizes the current evidence of interprofessional treatment in women with CPP.Material and methods: A systematic literature review was performed in six databases (Medline, Web of Science, Cochrane Library, PEDro, CINAHL, and PsycINFO) until February 2023. Studies were selected in a two‐step approach applying as inclusion criteria the search combinations of Chronic Pelvic Pain and CPP, synonyms for interprofessional therapies, and for female patients. Studies were excluded if they were not quantitative primary research published in English, if CPP was not defined appropriately, if the study population was not female adult patients, if the interprofessional intervention was not operationalized appropriately, if they were single case studies, and if outcomes did not include at least one of the psychosocial factors pain, depressive symptoms, pain catastrophizing, fear, or anxiety. Risk of bias of the included studies was rated with the McMaster Critical Review Form. Studies were summarized narratively. The review is registered in PROSPERO (CRD42023391008).Results: Five studies with a total sample size of n = 186 women were included, three of them were uncontrolled retrospective before‐after chart review. Only one study used a randomized controlled design, the other study used a non‐randomized controlled group. The studies' methodological quality is adequate with perspective of study design. The multiprofessional treatment approaches used in the studies differed with regard to professions involved, therapy methods, and modalities. Psychosocial outcome measures were pain (five studies), depressive symptoms (three studies), and anxiety symptoms (four studies).Conclusions: Although interprofessional treatment strategies for women with CPP are recommended in existing guidelines, available evidence is scarce and does not allow for identification of the best interprofessional treatment approach. The effect on psychosocial factors remains unclear. More research is needed determining the best practice interprofessional treatment option for women with CPP.
- 8 October 2022
- Published by Springer Nature
- p. 953-962
Professionalisierung und Handlungsfelder in den Gesundheitsfachberufen
- 8 October 2022
- Published by Springer Nature
- p. 953-962
Professionalisierung und Handlungsfelder in den Gesundheitsfachberufen
- Open Access
- 23 June 2022
- Published by Springer Nature in Trials
- Vol. 23 (1) , 1-11
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
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).
- 23 June 2022
- Published by Springer Nature in Trials
- Vol. 23 (1) , 1-11
Open AccessInterdisciplinary 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
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).
- Open Access
- 10 June 2022
- Published by Springer Nature in Research Square
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
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 three hours 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 twelve 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 27th, 2021; https://www.clinicaltrials.gov/ct2/show/NCT04977362).
- 10 June 2022
- Published by Springer Nature in Research Square
Open AccessInterdisciplinary 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
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 three hours 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 twelve 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 27th, 2021; https://www.clinicaltrials.gov/ct2/show/NCT04977362).