scholarly journals Assessing effectiveness and implementation of a perioperative enhanced recovery protocol for children undergoing surgery: study protocol for a prospective, stepped-wedge, cluster, randomized, controlled clinical trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Mehul V. Raval ◽  
Erin Wymore ◽  
Martha-Conley E. Ingram ◽  
Yao Tian ◽  
Julie K. Johnson ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Length Of Stay ◽  
Enhanced Recovery ◽  
Implementation Fidelity ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Primary Study ◽  
Stepped Wedge ◽  
Cluster Randomized ◽  
Us Intervention

Abstract Background Perioperative enhanced recovery protocols (ERPs) have been found to decrease hospital length of stay, in-hospital costs, and complications among adult surgical populations but evidence for pediatric populations is lacking. The study is designed to evaluate the adoption, effectiveness, and generalizability of a 21-element ERP, adapted for pediatric surgery. Methods The multicenter study is a stepped-wedge, cluster-randomized, pragmatic clinical trial that will evaluate the effectiveness of the ENhanced Recovery In CHildren Undergoing Surgery (ENRICH-US) intervention while also assessing site-specific adaptations, implementation fidelity, and sustainability. The target patient population is pediatric patients, between 10 and 18 years old, who undergo elective gastrointestinal surgery. Eighteen (N = 18) participating sites will be randomly assigned to one of three clusters with each cluster, in turn, being randomly assigned to an intervention start period (stepped-wedge). Each cluster will participate in a Learning Collaborative, using the National Implementation Research Network’s five Active Implementation Frameworks (AIFs) (competency, organization, and leadership), as drivers of facilitation of rapid-cycle adaptations and implementation. The primary study outcome is hospital length of stay, with implementation metrics being used to evaluate adoption, fidelity, and sustainability. Additional clinical outcomes include opioid use, post-surgical complications, and post-discharge healthcare utilization (clinic/emergency room visits, telephone calls to clinic, and re-hospitalizations), as well as, assess patient- and parent-reported health-related quality of life outcomes. The protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist. Discussion The study provides a unique opportunity to accelerate the adoption of ERPs across 18 US pediatric surgical centers and to evaluate, for the first time, the effect of a pediatric-specific ENRICH-US intervention on clinical and implementation outcomes. The study design and methods can serve as a model for future pediatric surgical quality improvement implementation efforts. Trial registration ClinicalTrials.gov NCT04060303. Registered on 07 August 2019.

scholarly journals An Organizational-Level Program of Intervention for AKI: A Pragmatic Stepped Wedge Cluster Randomized Trial

2019 ◽  
Vol 30 (3) ◽  
pp. 505-515 ◽  
Author(s):  
Nicholas M. Selby ◽  
Anna Casula ◽  
Laura Lamming ◽  
John Stoves ◽  
Yohan Samarasinghe ◽  
...  
Keyword(s):  
Length Of Stay ◽  
Randomized Trial ◽  
Cluster Randomized Trial ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Organizational Level ◽  
Care Process ◽  
Standards Of Care ◽  
Stepped Wedge ◽  
Cluster Randomized

BackgroundVariable standards of care may contribute to poor outcomes associated with AKI. We evaluated whether a multifaceted intervention (AKI e-alerts, an AKI care bundle, and an education program) would improve delivery of care and patient outcomes at an organizational level.MethodsA multicenter, pragmatic, stepped-wedge cluster randomized trial was performed in five UK hospitals, involving patients with AKI aged ≥18 years. The intervention was introduced sequentially across fixed three-month periods according to a randomly determined schedule until all hospitals were exposed. The primary outcome was 30-day mortality, with pre-specified secondary endpoints and a nested evaluation of care process delivery. The nature of the intervention precluded blinding, but data collection and analysis were independent of project delivery teams.ResultsWe studied 24,059 AKI episodes, finding an overall 30-day mortality of 24.5%, with no difference between control and intervention periods. Hospital length of stay was reduced with the intervention (decreases of 0.7, 1.1, and 1.3 days at the 0.5, 0.6, and 0.7 quantiles, respectively). AKI incidence increased and was mirrored by an increase in the proportion of patients with a coded diagnosis of AKI. Our assessment of process measures in 1048 patients showed improvements in several metrics including AKI recognition, medication optimization, and fluid assessment.ConclusionsA complex, hospital-wide intervention to reduce harm associated with AKI did not reduce 30-day AKI mortality but did result in reductions in hospital length of stay, accompanied by improvements in in quality of care. An increase in AKI incidence likely reflected improved recognition.

Comparing the effect of a consult model versus an integrated palliative care and medical oncology co-rounding model on health care utilization in an acute hospital – an open-label stepped-wedge cluster-randomized trial

2021 ◽  
Vol 35 (8) ◽  
pp. 1578-1589
Author(s):  
Grace M Yang ◽  
Siqin Zhou ◽  
Zhizhen Xu ◽  
Stella SL Goh ◽  
Xia Zhu ◽  
...  
Keyword(s):  
Palliative Care ◽  
Length Of Stay ◽  
Cluster Randomized Trial ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Specialist Palliative Care ◽  
Stepped Wedge ◽  
Open Label ◽  
Model Versus ◽  
Cluster Randomized

Background: The benefit of specialist palliative care for cancer inpatients is established, but the best method to deliver specialist palliative care is unknown. Aim: To compare a consult model versus a co-rounding model; both provide the same content of specialist palliative care to individual patients but differ in the level of integration between palliative care and oncology clinicians. Design: An open-label, cluster-randomized trial with stepped-wedge design. The primary outcome was hospital length of stay; secondary outcomes were 30-day readmissions and access to specialist palliative care. ClinicalTrials.gov number NCT03330509. Setting/participants: Cancer patients admitted to the oncology inpatient service of an acute hospital in Singapore. Results: A total of 5681 admissions from December 2017 to July 2019 were included, of which 5295 involved stage 3-4 cancer and 1221 received specialist palliative care review. Admissions in the co-rounding model had a shorter hospital length of stay than those in the consult model by 0.70 days (95%CI −0.04 to 1.45, p = 0.065) for all admissions. In the sub-group of stage 3-4 cancer patients, the length of stay was 0.85 days shorter (95%CI 0.05–1.65, p = 0.038). In the sub-group of admissions that received specialist palliative care review, the length of stay was 2.62 days shorter (95%CI 0.63–4.61, p = 0.010). Hospital readmission within 30 days (OR1.03, 95%CI 0.79–1.35, p = 0.822) and access to specialist palliative care (OR1.19, 95%CI 0.90–1.58, p = 0.215) were similar between the consult and co-rounding models. Conclusions: The co-rounding model was associated with a shorter hospital length of stay. Readmissions within 30 days and access to specialist palliative care were similar.

scholarly journals Implementation of an ERAS Pathway in Colorectal Surgery

2019 ◽  
Vol 32 (02) ◽  
pp. 102-108 ◽  
Author(s):  
Liliana Bordeianou ◽  
Paul Cavallaro
Keyword(s):  
Colorectal Surgery ◽  
Length Of Stay ◽  
Postoperative Care ◽  
Enhanced Recovery ◽  
Enhanced Recovery After Surgery ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Standardized Protocol ◽  
Improve Hospital ◽  
Eras Protocol

AbstractEnhanced Recovery after Surgery (ERAS) protocols have been demonstrated to improve hospital length of stay and outcomes in patients undergoing colorectal surgery. This article presents the specific components of an ERAS protocol implemented at the authors' institution. In particular, details of both surgical and anesthetic ERAS pathways are provided with explanation of all aspects of preoperative, perioperative, and postoperative care. Evidence supporting inclusion of various aspects within the ERAS protocol is briefly reviewed. The ERAS protocol described has significantly benefitted postoperative outcomes in colorectal patients and can be employed at other institutions wishing to develop an ERAS pathway for colorectal patients. A checklist is provided for clinicians to easily reference and facilitate implementation of a standardized protocol.

Newly implemented enhanced recovery pathway positively impacts hospital length of stay

2015 ◽  
Vol 30 (9) ◽  
pp. 4019-4028 ◽  
Author(s):  
Thomas D. Martin ◽  
Talya Lorenz ◽  
Jane Ferraro ◽  
Kevin Chagin ◽  
Richard M. Lampman ◽  
...  
Keyword(s):  
Length Of Stay ◽  
Enhanced Recovery ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Enhanced Recovery Pathway

scholarly journals Percutaneous ultrasound gastrostomy (PUG): first prospective clinical trial

2021 ◽  
Author(s):  
Fabio Accorsi ◽  
Jonathan Chung ◽  
Amol Mujoomdar ◽  
Daniele Wiseman ◽  
Stewart Kribs ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Length Of Stay ◽  
Point Of Care ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Human Trial ◽  
Institutional Control ◽  
Significant Difference ◽  
Registration Number ◽  
Related Mortality

Graphical abstarct Purpose To report the results of the first-in-human trial evaluating the safety and efficacy of the percutaneous ultrasound gastrostomy (PUG) technique. Methods A prospective, industry-sponsored single-arm clinical trial of PUG insertion was performed in 25 adult patients under investigational device exemption (mean age 64 ± 15 years, 92% men, 80% inpatients, mean BMI 24.5 ± 2.7 kg/m2). A propensity score-matched retrospective cohort of 25 patients who received percutaneous radiologic gastrostomy (PRG) was generated as an institutional control (mean age 66 ± 14 years, 92% men, 80% inpatients, mean BMI 24.0 ± 2.7 kg/m2). Primary outcomes included successful insertion and 30-day procedure-related adverse events (AE’s). Secondary outcomes included procedural duration, sedation requirements, and hospital length of stay. Results All PUG procedures were successful, including 3/25 [12%] performed bedside within the ICU. There was no significant difference between PUG and PRG in rates of mild AE’s (3/25 [12%] for PUG and 7/25 [28%] for PRG, p = 0.16) or moderate AE’s (1/25 [4%] for PUG and 0/25 for PRG, p = 0.31). There were no severe AE’s or 30-day procedure-related mortality in either group. Procedural room time was longer for PUG (56.5 ± 14.1 min) than PRG (39.3 ± 15.0 min, p < 0.001). PUG procedure time was significantly shorter after a procedural enhancement, the incorporation of a Gauss meter to facilitate successful magnetic gastropexy. Length of stay for outpatients did not significantly differ (2.4 ± 0.5 days for PUG and 2.6 ± 1.0 days for PRG, p = 0.70). Conclusion PUG appears effective with a safety profile similar to PRG. Bedside point-of-care gastrostomy tube insertion using the PUG technique shows promise. Trial Registration Number: ClinicalTrials.gov ID NCT03575754. Graphical abstract

Sign in / Sign up

Export Citation Format

Share Document