Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05541926 |
| Other study ID # |
8359 |
| Secondary ID |
R01MH130845 |
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2, 2023 |
| Est. completion date |
August 31, 2026 |
Study information
| Verified date |
August 2023 |
| Source |
New York State Psychiatric Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
We propose to conduct research on strategies that support the successful scale-up of an
evidence-based, suicidal risk and behavior identification and cross-system linkage programs
for justice-involved youth (e-Connect), and to rigorously evaluate the implementation
activities and associated costs that support that scale-up of e-Connect within 9 Indiana
counties. Guided by the GPM and EPIS frameworks, this 4-year study will comprise 3 project
phases: (1) Scale-Up Strategy Efforts, focused on preparing for scale-up; (2)
e-Connect-scaleup implementation (2a Exploration and Preparation and 2b Implementation and
Sustainment); and (3) Scale-Up Effectiveness Trial/Outcome Evaluation. The current project
draws on lessons learned from the e-Connect efficacy trial in NYS and research team
leadership will serve as External Facilitators to support 9 Local Facilitators to ensure the
successful transfer of knowledge, skill and expertise in delivering e-Connect in a new JJ
system and geographic context, utilizing implementation strategies to support the more
widespread, sustained and rigorous adoption of e-Connect. The study will include a learning
community created by External Facilitators for Local Facilitators to provide support, to
exchange strategies to handle implementation issues, to develop competencies in facilitation,
and to guide implementation throughout the program. The learning community will help Local
Facilitators navigate through the implementation stages of the study.
Description:
The proposed study will examine strategies to bolster the successful scale-up of e-Connect,
one of the few evidence-based suicide behavior identification and cross-system linkage
programs for youth on under community supervision. This proposal is from two PIs with
complimentary expertise in the justice system, implementation science, clinical decision
support systems, and use of large administrative data sets, and is supported by a strong
multi-disciplinary team to achieve study aims. Guided by the gateway provider model (GPM) and
the Exploration, Preparation, Implementation Sustainment (EPIS) implementation framework, we
now propose to extend our work of e-Connect, to develop and test a "purveyor model" of
implementation scale-up (i.e. e-Connect-scaleup). In e-Connect-scaleup, research team
leadership will serve as External Facilitators to support Local Facilitators to ensure the
successful transfer of knowledge, skill and expertise in delivering e-Connect in a new JJ
system and geographic context, utilizing implementation strategies to support the more
widespread, sustained and rigorous adoption of e-Connect. Working in 9 Indiana counties,
randomly assigned to one of three waves in a stepped-wedge, implementation-effectiveness
hybrid type-2 design, the specific aims are to examine the clinical and cost-effectiveness of
e-Connect-scaleup on (i) identification of youth service need (SB and BH correlates) in
juvenile probationers; (ii) cross-system (probation-BH agency) referral; and (iii) youth BH
service use (initial BH contact; primary outcome) by comparing the performance of e-Connect
to (a) standard probation officer practice (baseline) and (b) to rates achieved in the prior
efficacy trial of e-Connect (Aim 1). We will examine potential mediating or moderating
effects of EPIS/GPM inner and outer context factors We will also determine whether, at scale,
e-Connect can reduce race or gender health disparities in SB/BH service need identification,
cross-system referral and youth SB/BH service use (e.g. as compared to standard probation
practice (baseline), which would replicate the disparity-reducing performance of e-Connect in
NYS (Aim 2). Finally, we will examine the implementation of e-Connect-scaleup in terms of
fidelity and acceptability and compare advancement through the stages of implementation
through to sustainment across the 9 counties in order to demonstrate the feasibility of
scaling-up e-Connect in probation settings beyond NYS (Aim 3). We will elucidate the inner-
and outer-level EPIS- and GPM- derived factors that promote or hinder delivery of
implementation strategies and practice change to inform scale up across a variety of
contexts.
Settings. The sample for the proposed study will be recruited from probation staff,
partnering treatment agency staff, and probation youth from 9 counties in Indiana, which are
distributed across the state geographically. The counties range in population density, with 5
qualifying as Rural/Mixed and 4 as Urban. Each county participating in the proposed study is
also a member of the Indiana Juvenile Detention Alternatives Initiative, a nationwide
juvenile justice reform effort funded by the Annie E. Casey Foundation and adopted in nearly
a third of Indiana counties. The focus of JDAI is to limit the unnecessary detainment of
low-risk probation youth. Each JDAI county has developed committees of staff and community
members that use a data-driven process, one of the JDAI core strategies, to identify targets
of intervention, assess effectiveness of the interventions, and continue monitoring progress
to develop future interventions. Recognizing the benefits of JDAI, Indiana was the second
state to institute a central JDAI office to support statewide expansion. Each JDAI county has
a dedicated coordinator who will also act as Local Facilitator for e-Connect. See the map
indicating the location of participating sites relative to other JDAI counties and juvenile
detention centers.
Design, Sample Size and Randomization. In the proposed cluster randomized stepped-wedge
design, 9 Indiana counties will be randomized - stratified by population density/urbanicity
(as a proxy for staffing and resource availability) - to one of 3 waves of e-Connect-scale-up
at 3-month intervals.
We will examine the clinical and cost-effectiveness of e-Connect-scaleup on (i)
identification of youth service need (SB and BH correlates) in juvenile probationers; (ii)
cross-system (probation-BH agency) referral; and (iii) youth BH service use (initial BH
contact; primary outcome) by comparing the performance of e-Connect to (a) standard probation
officer practice (baseline) and (b) to rates achieved in the prior efficacy trial of
e-Connect (Aim 1). We will examine potential mediating or moderating effects of EPIS/GPM
inner (e.g. staff knowledge, organizational functioning) and outer context factors (e.g.
youth age, county rate of SB) on e-Connect-scaleup outcomes. We will also determine whether,
at scale, e-Connect can reduce race or gender health disparities in SB/BH service need
identification, cross-system referral and youth SB/BH service use (e.g. as compared to
standard probation practice (baseline), which would replicate the disparity-reducing
performance of e-Connect in NYS (Aim 2). Finally, we will evaluate the implementation of
e-Connect-scaleup in two ways (Aim 3). First, we will examine the fidelity and acceptability
of e-Connect-scaleup, including facilitation strategies. Second, we will document processes
of scaling up e-Connect, comparing advancement through the stages of implementation through
to sustainment across the 9 counties in order to demonstrate the feasibility of scaling-up
e-Connect in probation settings beyond NYS; we will explore the role of site differences and
other EPIS and GPM factors on implementation completion (Aim 3). By randomizing sites to
e-Connect-scaleup across time, the control group (which is changing over time) is taken to be
the sites that have not yet rolled out e-Connect-scaleup by a particular time, treatment as
usual (TAU). Data on these behavioral health care cascade outcomes are collected in each
county pre and post randomization to e-Connect-scaleup allowing for within site estimates of
change while controlling for secular changes over time. We will also examine potential effect
modifiers of e-Connect by youth, staff and county level inner and outer setting factors. To
examine impact and success of implementation strategies, we will compare stages of
implementation completion as well as feasibility and acceptability cross the 9 new counties,
exploring the role of site differences as well as other EPIS factors (outer-, inner-context
level) on implementation completion. There are two limitations to cluster randomized deigns:
potential of uneven distribution of potentially confounding variables within a cluster (i.e.
county) as well as interrelationship between variables. Our proposed stratification plan and
use of propensity matching will address issues related to confounding. We calculated our
ability to detect an effect of e-Connect-scaleup (i.e. power) using a conservative intraclass
correlation coefficient (ICC) of .65, denoting a moderate-large positive correlation between
outcomes within a county to address issues of interrelationship between variables at the
county level.
