Evaluation of a Covariate-Constrained Randomization Procedure in Stepped Wedge Cluster Randomized Trials

Join us as this presenter discusses this poster live on Tuesday, August 11, 2020 | Track A at 4:35 PM Mountain

PRESENTER
ERIN LEISTER CHAUSSEE
PhD Candidate, Colorado School of Public Health
BACKGROUND
In stepped wedge (SW) designs, differing cluster-level characteristics or individual-level covariate distributions that differ by cluster can lead to imbalance by treatment arm and potential confounding of the treatment effect.
SETTING
SW cluster randomized trials
METHODS
Adapting a method used in cluster-randomized trials, we propose a covariate-constrained randomization method to be used in SW designs. First, we define a balance metric to be calculated for all possible randomizations of cluster order for a given SW design (denoted BSW). The resulting distribution of this balance metric across all possible randomizations is used to select a candidate set of randomizations with acceptable covariate balance, for example, the best tenth percentile (P10) of the BSW distribution. One cluster order is selected at random from this candidate set to be used as the cluster order for treatment implementation. In a simulation study, we implement the covariate-constrained randomization procedure and computed treatment effect estimates and average absolute bias, and estimates of type I error and power. We used these outcomes to evaluate differing cutoffs of the BSW distribution used to define the candidate set and various analysis methods, under varying SW design and confounding settings.
RESULTS
We observed optimal statistical properties when the balance metric was used to exclude a small set of potential randomizations with the highest level of imbalance, and when analysis methods were adjusted for the potential confounders (see Figure for average absolute bias by BSW cutoff results). The covariate-constrained randomization was most beneficial in settings with a small number of clusters, low intra-class correlation, a low number of participants per cluster, and in the presence of cluster-level confounding variables.
CONCLUSIONS
We recommend researchers using the SW design carefully consider potential confounders, both cluster-level and individual-level, prior to cluster order randomization and consider a covariate-constrained randomization if appropriate. Treatment effect estimation should be adjusted for these potential confounders, and other covariates associated with the outcome of interest.
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VIDEO


Data Dashboard + Nudge Emails

Join us as this presenter discusses this poster live on Tuesday, August 11, 2020 | Track B at 5:15 PM Mountain

PRESENTER
BRIGID CONNELLY
Research Assistant, Denver/Seattle Center of Innovation for Veteran-Centered and Value Driven Care VA Eastern Colorado Healthcare System
BACKGROUND
Data dashboards are a common audit and feedback approach to support changes in processes and behavior. The rural Transitions Nurse Program (TNP) is a care coordination intervention for high-risk Veterans. An interactive dashboard was used to provide real-time performance metrics to sites. The feedback goal was to increase TNP Veteran discharges. One-year post implementation, discharge goals were not met. Control theory suggests that feedback using diverse methods can positively influence performance. Nudge emails can draw attention to performance metrics to improve awareness of current state. This study evaluated whether Veteran discharges and site communication increased when feedback occurred through a dashboard plus weekly nudge email versus dashboard alone.
POPULATION
This observational study reviewed discharge counts of urban, rural, and highly rural Veterans who were hospitalized and discharged from four VA hospitals participating in TNP. Transitions nurses and site champions implementing TNP at each site were surveyed.
METHODS
Veteran discharge counts during the dashboard phase were compared to discharges during the dashboard plus weekly nudge email phase. The emails included run charts (figure) with site discharge averages and weekly discharge counts. The difference of means for weekly discharges between the two phases was calculated using Poisson distribution. After 3 months of nudge emails, project time was calculated and a survey assessing nurse and champion perceptions of the nudge emails was distributed.
RESULTS
Our sample included four VA medical centers. The average weekly discharges for all sites during the ~20-month dashboard phase was 4.23 Veterans. The weekly average during the 3-month dashboard plus nudge email phase was 4.21 Veterans. The difference in means was -0.03 (p=0.73). Adjusting for time trends had no further effect. Project time to create and communicate nudge emails was ~14 hours over 3 months. Four nurses responded to the survey. Two reported neutral and two reported positive perceptions of the nudge emails. No site champions responded to the survey.
CONCLUSIONS
Drawing attention to metrics, through nudge emails, maintained, but did not increase TNP Veteran discharges compared to dashboard feedback alone. These findings suggest the nudge effort has no effect on TNP.
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VIDEO


Development of a Dissemination and Implementation Framework for an Early Childhood Obesity Prevention Program

Join us as this presenter discusses this poster live on Tuesday, August 11, 2020 | Track A at 4:55 PM Mountain

PRESENTER
EMILY BERGLING
DrPH Student, Colorado School of Public Health
BACKGROUND
Dissemination and implementation (D&I) research addresses the disconnect between evidence-based research and practical application in community settings. Many current evaluation approaches to school-based health programs have a limited focus on outcome measures. This neglects to account for additional factors that influence implementation and program success. The mixed effectiveness of early childhood education (ECE)-based obesity prevention programs and the complexity added by implementing multi-component programs calls for more comprehensive evaluation, and one that includes factors related to D&I.
SETTING
ECE settings are ideal for the application of D&I research due to their widespread use for implementing health interventions. The Culture of Wellness in Preschools (COWP) is a multi-component early childhood obesity prevention program, which aims to promote a “culture of wellness” in ECE settings by increasing fruit and vegetable consumption and physical activity levels.
METHODS
The COWP team convened a working group to focus on the D&I constructs that were relevant to the program. An informal literature search was conducted to assess the applicability of existing D&I frameworks. Two frameworks guided the development of the COWP framework, the Consolidated Framework for Implementation Research (CFIR)1 and an obesity-prevention specific framework developed by Dreisinger et al.2 These were supplemented with additional program specific constructs.
RESULTS
The COWP D&I framework was developed to inform the program’s implementation and evaluation efforts. The framework consists of six domains: process, stages of dissemination, system-level and contextual factors, intervention-level factors, structural and participant factors (organizational- and individual-level), and outcomes. Preliminary work applying the framework was conducted in 2019. A mixed-methods evaluation assessed D&I factors related to the one component of the COWP program: the COWP Policy, System and Environment (PSE) Change process. Findings suggest that the successful implementation of the process may be most impacted by staff attitudes and perceived importance, the current status of wellness policies, and the adaptability of the process to align with center culture and norms. Factors most related to the successful sustainability of this process may be skills, attitudes, support and engagement of the staff and leadership, and the quality rating score of the center.
CONCLUSIONS
The development of a D&I framework specific to COWP is an initial step in adopting a D&I focused approach to program evaluation and quality improvement. The COWP team plans to build off these preliminary findings to explore how to use this framework to guide the development of research questions, additional data collection, and future analyses related to the overall COWP program.
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