Enhancing Evidence-based Diabetes Control Among Local Health Departments
Phase: NA
Conditions: Organizational Support for Evidence-based Public Health
Sponsor: Washington University School of Medicine

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Protocol 
 
 
Disseminating Public Health Evidence to 
Support Prevention and Control of Diabetes  
Among Local Health Departments 
 
 
NCT03211832 
 
 
Updated October 11, 2021 
 
 
 
 
 

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A Stepped Wedge Cluster Randomized Controlled Trial 
 
We will conduct a stepped wedge cluster randomized controlled trial of 12 local health 
departments (LHDs) in Missouri to evaluate the effectiveness of active D&I approaches on 
perceived individual and organizational capacity for evidence-based decision making in 
prevention of diabetes and other chronic diseases.  
 
LHDs will be randomly assigned to three groups that crossover to receive the intervention with 
measurements at 8-month intervals. No LHDs receive the intervention at baseline. All 
participating 12 LHDs will receive the intervention, however, for varying durations; group 1 
crosses over from control, i.e., usual practice to receive the intervention activities first and for a 
total of 24 months, group 2 crosses over second and receives the intervention for 16 months, 
and group 3 crosses over last and receives the intervention activities for 8 months. The 
intervention activities include a flexible “menu” of D&I approaches that account for local 
contextual and organizational factors. Dissemination strategies are designed to build workforce 
and organizational capacity, and may include training in evidence-based public health, technical 
assistance through a knowledge broker, providing targeted messages/emails with a short 
summary of the research and actions that might be taken based on the evidence, and 
organizational changes to assist agency leadership in prioritizing, incentivizing and incorporating 
the use of EBPPs. LHD practitioners can choose intervention activities from this "menu". This 
"menu" approach avoids the pitfalls of a “one-size-fits-all” process that is unlikely to be effective 
across the 12 participating LHDs. Therefore, this study will not attempt to evaluate a single D&I 
intervention activity but will pursue active, multi-modal approaches, since these are supported in 
the literature. 
 
Local Health Department Enrollment 
 
Of the twelve LHDs selected, at least 3 will come from LHDs in counties with high diabetes 
disparity (highest tertile). Once all LHDs are recruited, each will be randomly assigned to one of 
three groups with four LHDs to a group. At least one LHD from high diabetes disparity will be 
randomly assigned to each group. Each group of LHDs will cross over to the intervention at 8-
month intervals. To account for varying sample sizes for small versus large LHDs, we will limit 
our sample to LHDs with at least 5 employees working in or supporting chronic disease control 
and on the upper end no more than 22 individuals in larger LHDs. We will also include an 
additional 5-10 individuals (an average of 8) from partner agencies in each local community that 
include non-governmental organizations (e.g., local hospital, American Diabetes Association) 
and governmental organizations outside of the health sector (e.g., universities, parks/recreation, 
schools). 
 
LHD selection will be based in part on the total number of full-time equivalent (FTE) employees 
(number of FTEs increases with size of population served by LHD), number of employees 
working in or supporting diabetes or chronic disease control, and diabetes burden, specifically 
mortality rate for diabetes as underlying cause (a measure of health disparity). Of the 12 LHDs 
selected and recruited, at least three will come from LHDs in counties from the highest tertile of 
mortality rate for diabetes as underlying cause. To be eligible, LHDs are required to have ≥5 
employees working in or supporting diabetes or related areas in chronic disease control, which 
includes program areas of diabetes prevention and management, obesity prevention, physical 
activity, nutrition, cardiovascular health, school health, and cancer screenings. In addition, each 
LHD must have a designee to work with the study team on aspects of the intervention. LHDs will 
be assigned to one of three groups (four LHDs to each group) using simple random concealed 
allocation performed by the statistician. 

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LHDs with a total number of FTEs ≥35 or serving a population of ≥200,000 are anticipated to 
have an adequate number of employees working in diabetes and chronic disease control. The 
project manager (RP) contacted directors at LHDs with 25-34 FTEs and serve a population of 
<200,000 (8 LHDs) to determine if their LHD has ≥5 employees working in diabetes prevention 
and management, obesity prevention, physical activity, nutrition, cardiovascular health, or 
cancer screenings; 5 of the 8 LHDs met this criterion. Of eligible LHDs (17 of 115 LHDs), those 
with the greatest diabetes burden (i.e., in the highest tertile for mortality rate for diabetes as 
underlying cause) followed by LHDs with the largest total number of FTEs employees will be 
contacted and recruited. Random assignment of the first 12 selected LHDs to groups will be 
performed. The principal investigator will invite local health directors from each selected LHD to 
have their employees working in diabetes and chronic disease control participate in the study. If 
any LHD declines, the next LHD according to total number of FTE employees will be selected. 
All employees working in or supporting diabetes and chronic disease control in participating 
LHDs will be invited into the study (complete listing), and a purposive sample of individuals from 
partner agencies (other governmental and non-governmental) in each LHD local community will 
also be invited. LHDs’ key partners will be recruited into the study with the help of the chronic 
disease managers and other practitioners. We anticipate a range of 5 to 22 participants from the 
LHDs, coupled with staff from partner agencies for an average of 22 per jurisdiction. 
 
Participants will be diabetes and chronic disease control directors, program managers and staff, 
and leadership from recruited LHDs in Missouri as well as staff from their key partner agencies. 
It is anticipated the participants will be from diverse backgrounds including health educators, 
epidemiologists, community health nurses, and persons with business backgrounds. 
 
Each LHD will have a designee (most likely the lead chronic disease staff person) who will 
provide the project coordinator a contact list of staff and practitioners working in and supporting 
chronic disease control, agency leadership, and staff at key partner agencies. The project/study 
coordinator will send an email to the list of contacts at the measurement time points (baseline, 
and three 8-month intervals) inviting them to participate in the dissemination survey. For the 
network analysis instrument, the invitation will occur at baseline and the last measurement time 
point. 
 
Table. Stepped wedge group randomized study design.  
Shaded cells represent intervention periods (24 months, 16 months, or 8 months). 
Months 
1-2 
3-10 
11-18 
19-26 
Group 1 
(4 LHDs) 
 
24 months 
 
 
Group 2 
(4 LHDs) 
 
 
 
 
Group 3 
(4 LHDs) 
 
 
 
8 months 
 
 
Individual Participant Consent Process 
16 months  
 

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For the web-based/online surveys (dissemination survey and network analysis instrument), the 
first page will be a cover letter containing all elements of consent. The cover letter will include a 
portion where individuals will be able to choose the statement that best describes how the 
individual would like to proceed ("Yes, I would like to take the survey," or "No, I prefer not to 
take the survey.”). If a person clicks "Yes, I would like to take the survey," this will indicate 
her/his consent and s/he will be directed to the start of the survey. If a person clicks "No, I prefer 
not to take the survey," this will indicate s/he does not consent and s/he will be directed to the 
end of the survey and no follow up invite/reminders will occur. Project staff will conduct follow up 
through email and telephone contact. In all contact with potential participants, project staff will 
emphasize that participation is voluntary. Specifically, health department personnel will be 
informed that if they choose to take part, they can change their mind and leave the survey. 
Further, they will be informed that any refusal to participate or withdrawal will not involve a 
penalty or loss of benefits to which they are otherwise entitled. 
 
Intervention: Individual and Organizational Capacity Building Activities 
 
The capacity building (intervention) activities seek to build workforce and organizational 
capacity, and to effectively package and provide information so that it is timely, relevant, and 
useful for various local-level practitioners. There will be a menu of capacity building 
(intervention) activities in which each LHD can choose depending on what the LHDs deems 
important, relevant and feasible. The intervention period for groups begins with workshops as 
described below. A full set of examples of capacity building activities is shown in an attached 
table (Intervention Activities). A narrative summary of potential activities are listed below. 
 
1. Targeted dissemination workshops – promoting the use of EBPPs will be modeled after 
successful workshops that have been conducted to promote evidence-based decision making 
(Brownson et al., 2009, Gibbert et al., 2013). The workshops will seek to enhance participants’ 
abilities to: understand the role of EBPPs in addressing the diabetes burden; identify diabetes 
control strategies recommended by evidence-based reviews (e.g., the Community Guide); adapt 
EBPPs to address health disparities; address organizational barriers to EBPPs; and take action 
steps to move toward implementation and evaluation of EBPPs. All workshops incorporate 
principles of science-based training, including: an informal setting, team training, experiential 
learning, and small group activities applicable to real world experiences. A sample workshop 
agenda with a brief description of the modules is attached to this IRB form (EBPH Workshop 
Agenda). 
 
2. Knowledge brokers – provide a link between research and practitioners by developing a 
mutual understanding of goals and cultures, collaborating with end users to identify problems for 
which solutions are required, and enhancing access and use of research evidence in practice 
and policy. This dissemination strategy has been used more in Canada than in the US. Although 
the public health literature is sparse with evaluations of knowledge broker impact, there is 
considerable evidence of effectiveness in other fields, particularly from business and agricultural 
sectors (Hargadon 2005, Verona et al., 2006, Zook 2004). The knowledge broker activities 
include: assistance with needs assessments and strategic planning that incorporate EBPPs; 
consultation on overcoming barriers to EBPPs; help with grant writing that incorporates 
information from evidence-based sources; and participation in the dissemination workshops 
described below. Interaction with the brokers will be one-on-one (broker to individuals and 
teams within the LHD) and it includes face-to-face contact, and remote telephone, email, and 
video communication. 
 

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3. Organizational changes – during the intervention period for each LHD, the research team will 
work with the LHDs to identify and implement a range of strategies to foster organizational 
change consistent with Institutional Theory that is part of the project's conceptual framework. 
Examples of strategies that will be employed will seek to: identify ways agency leadership can 
prioritize use of EBPPs, develop incentives for use of EBPPs, and incorporate EBPPs as a core 
component of agency practices (e.g., performance reviews, contracts with local partners). 
 
Data Collection 
 
To evaluate the impact of these intervention activities, we will:  
 
1) ask staff/practitioners working in/supporting chronic disease control at each LHD, and their 
partner organizations to complete the online dissemination survey at four time points (baseline 
and three 8-month intervals);  
 
2) ask for LHD records - program plans and progress reports that LHDs submits to funders, 
such as the Missouri Department of Health and Senior Services at two time points (baseline and 
the last data time point);  
 
3) ask for information on the external partnerships of each LHD (baseline and the last data time 
point), and then ask LHD leadership - manager level and above to complete the online network 
analysis survey at two time points (baseline and the last data time point). The surveys will be 
designed for minimal time burden (about 20 minutes). 
 
Power Analysis 
 
This study uses a stepped wedge cluster randomized design. Based on our preliminary studies 
and values of ICC in the literature, we estimated a range of effect sizes and ICCs. ICC 
estimates are the most difficult to obtain. We calculated a median ICC from similar studies and 
developed a range based on a 50% decrease and increase around the median (range 0.009 to 
0.027). The sample size requirement is based on testing hypotheses with a power of >90% and 
the overall Type I error of 5% given 12 clusters (LHDs). The null hypotheses suggest there 
would be no change in the scores from baseline of three outcomes—awareness, adoption, and 
maintenance—in all three groups of LHDs (no change). Drawing from our previous work, we 
hypothesize that the scores will be 17%, 20%, 14% higher for awareness, adoption, and 
maintenance from baseline to end of study, respectively. Following Baio et. al., and using the 
most conservative estimates of effect sizes and ICCs, we estimate a need for 12 LHDs, 3 steps 
or groups (of LHDs), and 10 subjects in each LHD (total = 120) to ensure 5 at the last 
measure/end of study (total = 60). 
 
 
Analysis Plan 
 
Descriptive statistics for participant and LHD characteristics and main outcomes will be 
conducted by trial mode. We will calculate gap in each skill for EBDM by subtracting availability 
from importance Likert rating (possible range of -10 to +10). An overall skill gap will be created 
by taking the average across all 10 skill items. We summed all 8 possible EBIs to calculate an 
“EBI score” which had a possible range of 0-8. For organizational culture items, we grouped and 
averaged Likert items within six main focus areas based on previous work: awareness of culture 
supportive of EBDM, capacity and expectations for EBDM, resource availability, evaluation 
capacity, EBDM climate cultivation, and partnerships to support EBDM (20). A confirmatory 

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factor analysis using data from all four time points according to standard procedures 
demonstrated adequate fit and strict measurement invariance of the factor structure used for the 
national survey in an earlier study phase. We used linear mixed-effect regression models for 
each outcome with LHD and Participant entered as random intercepts, trial mode (control or 
intervention) as fixed effect, and time as a categorical fixed effect. Public health degree, years 
worked in the public health field, job position category and accreditation status were entered as 
fixed effects. Kenward-Rogers approximations will be used to determine significance of fixed 
effects, a common approach in fitting restricted maximum likelihood models in order to produce 
acceptable Type 1 error. Where models violated assumptions of homoscedasticity, robust 
models will be approximated. Survey data will be cleaned initially in SPSS and then managed 
and analyzed in R. 
 
Table. Summary of individual and organizational capacity building (intervention) activities 
Domain 
Activity 
Description 
Accreditation 
Accreditation 
preparations 
Local health assessment and plan, formalized decision 
making, documentation of evidence, documentation 
reviews, site visit, approval 
Access to 
scientific 
information 
Targeted 
messages 
Participants will receive an email indicating that a 
systematic review related to diabetes or chronic disease 
control is available 
Workforce 
development 
Evidence-based 
decision making 
(EBDM) training 
(dissemination 
workshops) 
In-state, in-person multi-day training in EBDM skills, 9 
modules, as initial study intervention (this is the kick-off 
activity for the entire study) 
Supplemental 
brief EBDM skill 
trainings  
Provided by study team or state chronic disease unit, in-
person or webinar, as part of  this study, with 3 states 
emphasizing evaluation skills 
Non-study 
national trainings 
Hosted in-person EBDM-related skill trainings by 
national organizations and/or encouraged out-of-state 
training beyond those required by funders  
Quality 
improvement  
Quality improvement or performance management 
trainings, guidance 
New employee 
EBDM orientation  
Via archived webinars or course materials, facilitated 
discussions, meetings 
Leadership, 
management 
supports 
Chronic disease 
leadership teams 
expect EBDM  
Leaders and supervisors continually ask ‘what is the 
evidence’, communicate EBDM expectations to staff, 
champion EBDM, encourage use of data for decision 
making, encourage skill building  
Use of data for 
decision making  
Use data to prioritize programs, develop work plans, and 
monitor progress; share performance measures, data on 
intranet or centralized data systems 
Centralized data 
systems 
Dashboard development to prioritize, measure, and track 
objectives and link to evidence base; share performance 
measures and data  
Meetings 
incorporate 
EBDM 
Work unit and cross-section meetings address EBDM, 
present evidence, plans;  (in leadership and in training) 

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Performance 
reviews and 
EBDM 
Work unit employee evaluations include objectives on 
EBDM learning and application 
Hiring practices 
address EBDM 
Job descriptions, interview questions address EBDM; 
hire people with public health competencies; hire 
specialty staff including evaluators and epidemiologists 
Participatory 
decision making 
Staff and partner input obtained, sharing of information 
for decision making 
Common 
language for 
EBDM 
Creating and using common EBDM language across 
program areas 
Administrative 
reorganization for 
coordination 
Organizational restructuring at the unit or section levels 
to increase coordination across programs and conduct 
joint projects across programs 
Organizational 
changes 
EBDM engrained  
EBDM an embedded inseparable aspect of day-to-day 
work; strong expectation from leadership; high priority   
Learning 
orientation 
Culture supports professional development and ongoing 
learning, providing links to webinars, bringing in guest 
speakers  
Relationships 
and 
partnerships 
Partnerships with 
in-state 
universities 
Ongoing partnering for evaluation, trainings, internship 
placement 
Partner technical 
assistance and 
training 
Phone and in-person guidance for partners’ evidence-
based work plans, evaluation, logic models; Provide 
EBDM trainings to partners  
Relationship 
building  
Active steps to build or maintain positive partner 
relationships with open communication, trust, mutual 
respect, ensuring partner engagement and coalition 
development   
Financial 
practices 
Performance-
based contracting 
Funded partners required to implement evidence-based 
approaches as prescribed or selected from a menu, with 
performance objectives, work plans, and evaluation; 
holding contracted partners accountable for evidence-
based interventions 
Proposals 
approved 
internally for 
EBDM prior to 
submission to 
funder 
Local health department pre-approval process for grant 
applications to funders with requirements to show 
objectives, evidence basis, performance measures, 
evaluation plan