scholarly journals Comparative Effectiveness of Direct Admission & Admission through Emergency Departments for Children: A Randomized Stepped Wedge Study Protocol

2020 ◽  
Author(s):  
JoAnna K. Leyenaar ◽  
Corrie E McDaniel ◽  
Stephanie Acquilano ◽  
Andrew Schaefer ◽  
Martha L. Bruce ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hospital Admission ◽  
Emergency Departments ◽  
Controlled Trial ◽  
Healthcare Systems ◽  
Care Practice ◽  
Stepped Wedge ◽  
Randomized Controlled ◽  
Experience Of Care ◽  
Direct Admission

Abstract Background: Approximately 2 million children are hospitalized each year in the United States, with more than three-quarters of non-elective hospitalizations admitted through emergency departments (EDs). Direct admission, defined as admission to hospital without first receiving care in the hospital’s ED, may offer benefits for patients and healthcare systems in quality, timeliness, and experience of care. While ED utilization patterns are well studied, there is a paucity of research comparing the effectiveness of direct and ED admissions. The overall aim of this project is to compare the effectiveness of a standardized direct admission approach to admission beginning in the ED for hospitalized children.Methods/Design: We will conduct a stepped wedge cluster randomized controlled trial at 3 structurally and geographically diverse hospitals. A total of 70 primary and urgent care practice sites in the hospitals’ catchment areas will be randomized to a time point when they will begin participation in the multi-stakeholder informed direct admission program. This crossover will be unidirectional and occur at 4 time points, six months apart, over a 24-month implementation period. Our primary outcome will be the timeliness of clinical care provision. Secondary outcomes include: (i) parent-reported experience of care; (ii) unanticipated transfer to the intensive care unit within 6 hours of hospital admission; and (iii) rapid response calls within 6 hours of hospital admission. We anticipate that 190 children and adolescents will be directly admitted, with 1506 admitted through EDs. Analyses will compare the effectiveness of direct admission to admission through the ED, and will evaluate the causal effect of implementing a direct admission program using linear regression with random effects for referring practice clusters and time period fixed effects. We will further examine heterogeneity of treatment effects based on hypotheses specified a priori. In addition, we will conduct a mixed-methods process evaluation to assess reach, effectiveness, adoption, implementation and maintenance of our direct admission intervention.Discussion: Our study represents the first randomized controlled trial to compare the effectiveness of direct admission to admission through the ED for pediatric patients. Our scientific approach, pairing a stepped-wedge design with a multi-level assessment of barriers to and facilitators of implementation, will generate valuable data about how positive findings can be reproduced across other healthcare systems.Trial registration: This trial is registered in ClinicalTrials.gov (NCT04192799, registered December 10, 2019, https://clinicaltrials.gov/ct2/show/NCT04192799)

scholarly journals Comparative effectiveness of direct admission and admission through emergency departments for children: a randomized stepped wedge study protocol

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
JoAnna K. Leyenaar ◽  
Corrie E. McDaniel ◽  
Stephanie C. Acquilano ◽  
Andrew P. Schaefer ◽  
Martha L. Bruce ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hospital Admission ◽  
Emergency Departments ◽  
Controlled Trial ◽  
Healthcare Systems ◽  
Care Practice ◽  
Stepped Wedge ◽  
Randomized Controlled ◽  
Experience Of Care ◽  
Direct Admission

Abstract Background Approximately 2 million children are hospitalized each year in the United States, with more than three-quarters of non-elective hospitalizations admitted through emergency departments (EDs). Direct admission, defined as admission to hospital without first receiving care in the hospital’s ED, may offer benefits for patients and healthcare systems in quality, timeliness, and experience of care. While ED utilization patterns are well studied, there is a paucity of research comparing the effectiveness of direct and ED admissions. The overall aim of this project is to compare the effectiveness of a standardized direct admission approach to admission beginning in the ED for hospitalized children. Methods/design We will conduct a stepped wedge cluster randomized controlled trial at 3 structurally and geographically diverse hospitals. A total of 70 primary and urgent care practice sites in the hospitals’ catchment areas will be randomized to a time point when they will begin participation in the multi-stakeholder informed direct admission program. This crossover will be unidirectional and occur at 4 time points, 6 months apart, over a 24-month implementation period. Our primary outcome will be the timeliness of clinical care provision. Secondary outcomes include (i) parent-reported experience of care, (ii) unanticipated transfer to the intensive care unit within 6 h of hospital admission, and (iii) rapid response calls within 6 h of hospital admission. We anticipate that 190 children and adolescents will be directly admitted, with 1506 admitted through EDs. Analyses will compare the effectiveness of direct admission to admission through the ED and will evaluate the causal effect of implementing a direct admission program using linear regression with random effects for referring practice clusters and time period fixed effects. We will further examine the heterogeneity of treatment effects based on hypotheses specified a priori. In addition, we will conduct a mixed-methods process evaluation to assess reach, effectiveness, adoption, implementation, and maintenance of our direct admission intervention. Discussion Our study represents the first randomized controlled trial to compare the effectiveness of direct admission to admission through the ED for pediatric patients. Our scientific approach, pairing a stepped wedge design with a multi-level assessment of barriers to and facilitators of implementation, will generate valuable data about how positive findings can be reproduced across other healthcare systems. Trial registration ClinicalTrials.gov NCT04192799. Registered on December 10, 2019).

scholarly journals Narrative enhancement and cognitive therapy (NECT) to improve social functioning in people with serious mental illness: study protocol for a stepped-wedge cluster randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
J. Dubreucq ◽  
M. Faraldo ◽  
M. Abbes ◽  
B. Ycart ◽  
H. Richard-Lepouriel ◽  
...  
Keyword(s):  
Mental Illness ◽  
Randomized Controlled Trial ◽  
Cognitive Therapy ◽  
Social Functioning ◽  
Serious Mental Illness ◽  
Controlled Trial ◽  
Control Group ◽  
Stepped Wedge ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Background Self-stigma is highly prevalent in serious mental illness (SMI) and is associated with poorer clinical and functional outcomes. Narrative enhancement and cognitive therapy (NECT) is a group-based intervention combining psychoeducation, cognitive restructuring and story-telling exercises to reduce self-stigma and its impact on recovery-related outcomes. Despite evidence of its effectiveness on self-stigma in schizophrenia-related disorders, it is unclear whether NECT can impact social functioning. Methods This is a 12-centre stepped-wedge cluster randomized controlled trial of NECT effectiveness on social functioning in SMI, compared to treatment as usual. One hundred and twenty participants diagnosed with schizophrenia, bipolar disorder or borderline personality disorder will be recruited across the 12 sites. The 12 centres participating to the study will be randomized into two groups: one group (group 1) receiving the intervention at the beginning of the study (T0) and one group (group 2) being a control group for the first 6 months and receiving the intervention after (T1). Outcomes will be compared in both groups at T0 and T1, and 6-month and 12-month outcomes for groups 1 and 2 will be measured without a control group at T2 (to evaluate the stability of the effects over time). Evaluations will be conducted by assessors blind to treatment allocation. The primary outcome is personal and social performance compared across randomization groups. Secondary outcomes include self-stigma, self-esteem, wellbeing, quality of life, illness severity, depressive symptoms and personal recovery. Discussion NECT is a promising intervention for reducing self-stigma and improving recovery-related outcomes in SMI. If shown to be effective in this trial, it is likely that NECT will be implemented in psychiatric rehabilitation services with subsequent implications for routine clinical practice. Trial registration ClinicalTrials.gov NCT03972735. Trial registration date 31 May 2019.

scholarly journals Early recognition and response to increases in surgical site infections using optimized statistical process control charts—the Early 2RIS Trial: a multicenter cluster randomized controlled trial with stepped wedge design

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Deverick J. Anderson ◽  
Iulian Ilieş ◽  
Katherine Foy ◽  
Nicole Nehls ◽  
James C. Benneyan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Process Control ◽  
Statistical Process Control ◽  
Controlled Trial ◽  
Surgical Site Infections ◽  
Stepped Wedge ◽  
Statistical Process ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
Traditional Surveillance

Abstract Background Surgical site infections (SSIs) cause significant patient suffering. Surveillance and feedback of SSI rates is an evidence-based strategy to reduce SSIs, but traditional surveillance methods are slow and prone to bias. The objective of this cluster randomized controlled trial (RCT) is to determine if using optimized statistical process control (SPC) charts for SSI surveillance and feedback lead to a reduction in SSI rates compared to traditional surveillance. Methods The Early 2RIS Trial is a prospective, multicenter cluster RCT using a stepped wedge design. The trial will be performed in 29 hospitals in the Duke Infection Control Outreach Network (DICON) and 105 clusters over 4 years, from March 2016 through February 2020; year one represents a baseline period; thereafter, 8–9 clusters will be randomized to intervention every 3 months over a 3-year period using a stepped wedge randomization design. All patients who undergo one of 13 targeted procedures at study hospitals will be included in the analysis; these procedures will be included in one of six clusters: cardiac, orthopedic, gastrointestinal, OB-GYN, vascular, and spinal. All clusters will undergo traditional surveillance for SSIs; once randomized to intervention, clusters will also undergo surveillance and feedback using optimized SPC charts. Feedback on surveillance data will be provided to all clusters, regardless of allocation or type of surveillance. The primary endpoint is the difference in rates of SSI between the SPC intervention compared to traditional surveillance and feedback alone. Discussion The traditional approach for SSI surveillance and feedback has several major deficiencies because SSIs are rare events. First, traditional statistical methods require aggregation of measurements over time, which delays analysis until enough data accumulate. Second, traditional statistical tests and resulting p values are difficult to interpret. Third, analyses based on average SSI rates during predefined time periods have limited ability to rapidly identify important, real-time trends. Thus, standard analytic methods that compare average SSI rates between arbitrarily designated time intervals may not identify an important SSI rate increase on time unless the “signal” is very strong. Therefore, novel strategies for early identification and investigation of SSI rate increases are needed to decrease SSI rates. While SPC charts are used throughout industry and healthcare to improve and optimize processes, including other types of healthcare-associated infections, they have not been evaluated as a tool for SSI surveillance and feedback in a randomized trial. Trial registration ClinicalTrials.govNCT03075813, Registered March 9, 2017.

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