Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03715335 |
| Other study ID # |
CIN001-STI Screening |
| Secondary ID |
1R01HD094213-01A |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 20, 2020 |
| Est. completion date |
July 31, 2024 |
Study information
| Verified date |
July 2023 |
| Source |
Children's Hospital Medical Center, Cincinnati |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Sexually transmitted infections (STIs) are highly prevalent among adolescents. Despite
established principles for STI control, clinical practices related to screening and
diagnosis, treatment, and prevention of STIs among adolescents are suboptimal. There is an
urgent need to expand our screening programs to nontraditional healthcare settings such as
emergency departments (ED) to reach those adolescents who would otherwise not receive
preventive healthcare, and to determine the most efficient and cost-effective method for
providing this screening. The goal of this study is to leverage our recent insights obtained
from single center ED-based adolescent gonorrhea and chlamydia screening research and apply
them across a national pediatric ED research network to determine the most clinically
effective and cost-effective screening approach for adolescents when implemented into a
real-world clinical setting through a pragmatic trial. This will be accomplished through a
network of children's hospital EDs with a track record of robust research collaboration
(Pediatric Emergency Care Applied Research Network or PECARN). This intervention will rely on
an innovative approach that electronically integrates patient-reported data to guide clinical
decision support. The investigators will apply human factors modeling methods to perform ED
workflow evaluations at each participating pediatric ED to determine the most efficient way
to integrate the screening process into everyday clinical care. Following these analyses, the
investigators will conduct a comparative effectiveness pragmatic trial of targeted STI
screening (screening only those disclosing high risk sexual behavior) versus
universally-offered STI screening (offered to all, regardless of risk) through electronic
integration of patient reported data for provision of clinical decision support. The
investigators will then develop decision analytic models to evaluate the cost-effectiveness
of targeted screening compared to universally offered screening.
Description:
Adolescents are disproportionately affected by sexually transmitted infections (STIs). The
STI epidemic among youth is a national public health priority as noted in the Healthy People
2020 objectives, which specifically recommend enhanced STI diagnosis, treatment, and
reduction in adolescents. Failure to diagnose and treat STIs in a timely manner results in
serious reproductive morbidity, mortality, and increased transmission of disease.
Adolescents frequently access the emergency department (ED) for care, with the ED functioning
as the primary source of health care for over 1.5 million adolescents. EDs are potentially
high-yield sites for the delivery of sexual health services as part of a larger public health
prevention strategy. Although the Centers for Disease Control and Prevention (CDC) recommend
universal HIV screening in EDs, no recommendations currently exist for gonorrhea and
chlamydia (GC/CT) screening. Addressing the effectiveness and integration of ED-based STI
screening is critically needed.
Insufficient knowledge of the ideal structure for delivery (i.e. universally-offered or
targeted to high risk groups) is a barrier to the implementation of ED-based GC/CT screening.
While universally-offered screening (offered to all, regardless of risk) may detect a larger
number of cases than targeted screening (screening only those disclosing high risk sexual
behavior), it is more resource-intensive and may result in more false positive cases due to a
lower pretest probability of infection. The investigators each study targeted (Goyal) and
universally-offered (Reed) ED-based GC/CT screening via electronically entered
patient-reported data providing real-time clinical decision support (CDS). They have shown
that both strategies are acceptable, feasible, and result in increased STI screening rates at
their respective pediatric EDs; but it is unknown which method is most efficient and cost
effective when instituted across a national sample of pediatric EDs with varying community
STI prevalence.
The scientific premise of this application is to leverage recent insights obtained from
single center ED-based adolescent GC/CT screening research and apply them across a national
pediatric ED research network to determine the most clinically effective and cost-effective
screening approach for adolescents when implemented in a real-world clinical setting through
a pragmatic trial. To be successful and sustainable, the ideal screening strategy must be
easily incorporated into the clinical workflow. Electronic integration of patient-reported
data with CDS offers one such solution with additional benefits: overcomes privacy concerns,
circumvents provider biases about STI risk, and enables early detection of infection before
development of adverse sequelae. The objective of this study is to compare targeted and
universally-offered STI screening approaches by seamlessly integrating real-time CDS based on
electronically-obtained patient-reported data into the normal ED workflow through human
factors analysis followed by cost-effectiveness analyses. The investigators will execute a
multicenter comparative effectiveness pragmatic trial within a national sample of pediatric
EDs through the Pediatric Emergency Care Applied Research Network (PECARN).
Specific Aim 1: To compare the effectiveness of usual care, targeted screening and
universally-offered screening in EDs through a pragmatic trial that applies a human factors
systems approach to implement GC/CT screening into routine clinical care.
Specific Aim 2: To determine the most cost-effective approach for GC/CT detection (i.e. usual
care, targeted screening, and universally-offered screening) in an adolescent ED population.
Study Design:
1. Workflow Evaluations: The investigators will first perform ED workflow evaluations to
determine how to best integrate new processes into current workflow by applying a human
factors workflow process mapping approach at each participating pediatric ED. Data from
these methods will enable the development of site-specific adaptations for the
implementation of electronically-enhanced STI screening processes that use patient
reported outcomes (PROs) to generate CDS. This process is necessary to optimize the
experimental environment by ensuring usability, which will be essential for adoption of
this comparative effectiveness trial.
2. Pragmatic Trial: The investigators will then conduct a comparative effectiveness
pragmatic trial using a stepped wedge crossover design. The design also allows the
investigators to control for the effects of secular trends (e.g. changes that are
outside the interventions of the study). This was designed as a pragmatic trial to
evaluate the performance of these screening strategies in routine clinical care, rather
than under strict experimental conditions. Sites will be randomized to one of six
positions. After collecting baseline data, each site will subsequently be randomized to
either start with implementation of a targeted screening intervention (T) or a
universally offered screening intervention (U). Each site will then cross-over and
implement the opposite strategy. The final intervention will continue until the
conclusion of the study.
3. Cost-effectiveness analysis: Even if clinical strategies, such as universally offered
screening for STIs, are proven to be effective, the costs of those strategies compared
with usual care or more targeted approaches may make them impractical and unsustainable
in a cost-constrained healthcare system. The result of a cost-effectiveness analysis is
the incremental cost-effectiveness ratio (ICER), which describes the additional cost of
the more expensive but more effective strategy being examined, in this case universally
offered STI screening, compared with the lesser cost of the less effective strategy (we
have hypothesized this will be targeted screening) divided by the measure of
effectiveness being considered. For this project, the investigators plan to look at
additional cost per STI detected, as well as cost per QALY gained. The investigators
will develop decision analytic models (using Markov state transition structure) to
evaluate the cost-effectiveness of universally offered screening compared with targeted
screening. To be complete, "usual care" will be included as a third strategy. A simple
model will only examine effectiveness in terms of STIs detected. A more complicated
model will include short- and long-term consequences of treated and untreated disease.
Short-term outcomes will include the likelihood of follow-up and treatment once a
diagnosis has been made, along with the efficacy of antibiotic therapy. Based on test
characteristics from the literature, small numbers of patients may have false positive
or false negative test results. The investigators will model the consequences of both,
in terms of additional costs and consequences of unnecessary treatment for false
positives, and the costs and consequences of undetected/untreated STI in the case of
false negatives. Outcomes also will be modeled for unscreened patients who later return
for treatment of symptomatic disease (e.g., acute pelvic inflammatory disease).
Long-term outcomes addressing the sequelae of untreated/ undetected STIs (tubal
infertility, ectopic pregnancy, and chronic pelvic pain) and outcomes following
successful detection and treatment will be modeled. Data generated from Aim 2 regarding
the effectiveness of the two screening strategies in detecting GC/CT, the proportion of
identified patients who ultimately receive treatment, and the prevalence ranges of GC
and CT in cohorts presenting for ED care at the 6 sites in this study, will be used to
inform probabilities in the model. Literature-based estimates will inform other
probabilistic events and costs of long-term STI sequelae in the model. Incremental
cost-effectiveness ratios will be calculated to determine cost-effectiveness. The
analysis will use a health care sector perspective that includes medical costs borne by
third-party payers and paid out-of-pocket by patients. These will include current and
future costs related to both the intervention and downstream events related to treated
or missed STIs. The investigators will perform a series of deterministic sensitivity
analyses to explore the impact of parameter uncertainty on results, and known population
variations. A key parameter of interest is the background rate of STI. This likely
varies from location-to-location, and will be a key determinant to the
cost-effectiveness of the universally offered screening strategy. The threshold of
background STI prevalence above which universally offered screening becomes "very
cost-effective" (i.e., an ICER < $50,000/QALY) will be calculated. As a result, the
cost-effectiveness of the universally offered screening strategy may vary from location
to location in the study, and in real-world use of the screening tool. Understanding
this threshold may help shape policy for optimal screening strategies in different
locations and settings.
Study Procedures:
1. Human Factors Workflow Analyses: Human factors workflow evaluations will occur at each
of the 6 participating sites. These observations will be conducted to understand
site-specific ED flow differences that may occur with respect to the care of
adolescents. Observational data will be collected regarding ED workflow and information
exchange using the tool TaskTracker to record clinical workflow and identify common
workflow paths. These observations will be conducted during different times of the day
to account for variation in ED volume and staffing fluctuations.
2. Pragmatic Trial: Once the ideal workflow strategy is identified at each individual site,
all participants in both the targeted and universally offered screening phases will use
a handheld tablet device to provide electronic informed consent for participation. All
participants will complete the previously developed and validated ACASI SHS containing
questions regarding their personal sexual health history. The PROs tool will
risk-stratify patients for STIs based on their reported sexual experience and/or
presence of STI-related symptoms. Using the tablet device, patients will also provide
consent for clinician-ordered STI testing (urine-based GC/CT). This will provide
clinicians real-time EHR-integrated decision support for GC/CT testing. Since this is a
pragmatic trial, the exact process of distributing tablets may differ by site and will
be further clarified during the workflow analyses. The electronic informed consent
document will contain information about the study. Reasons for not offering the tablet
will be recorded by the ED staff. Furthermore, if adolescents decline study
participation, a reason for refusal will also be recorded on the tablet.
1. Targeted screening: During the targeted screening intervention, data from the SHS
will be integrated into the EHR and will provide CDS for GC/CT testing based on
SHS-calculated STI risk. Patients will be classified as at high risk for STIs if
they disclose being sexually active and have either the presence of STI-related
symptoms or any of the following high risk behaviors: more than 1 sexual partner in
the last 3 months, no condom use during last sex, prior history of STI. Patients
will be classified as at risk if they disclose being sexually active but do not
disclose having any STI-related symptoms or any high-risk sexual behaviors.
Patients will be classified as at low risk if they deny any history of sexual
activity. When patients classify as at high risk, clinicians will receive CDS that
STI testing is "highly recommended"; when they care for patients who classify as at
risk, they will receive CDS that STI testing is "recommended"; when caring for
patients who classify as at low risk, they will receive CDS that STI testing "is
not necessary at this time." If the clinician chooses to follow the recommendation
for screening based on patient's risk assessment, and the patient consents to
testing on the tablet device, urine GC/CT testing will be performed.
2. Universally offered screening: During the universally offered screening
intervention, STI screening will be offered to all eligible adolescents, regardless
of risk. All eligible patients will also complete the SHS, will be informed of the
CDC GC/CT testing recommendations and then be given the option to decline STI
testing using the tablet device. During this phase, the SHS results will not be
available to the clinician. STI testing recommendations will be based only on the
patient's decision to undergo GC/CT testing. Like the process followed in the
targeted screening phase, if the clinician follows the CDS that informs the
clinician that the patient agreed to GC/CT screening and consequently orders
testing, urine GC/CT testing will be performed.
3. Both approaches: If the patient is at risk for STIs and declines GC/CT testing, or
the patient simply declines GC/CT testing on the tablet but the clinician believes
the patient should be tested, the clinician will have the opportunity to engage in
a shared decision-making process with the patient as per routine clinical care.
Alternatively, if the clinician declines the CDS GC/CT testing recommendations,
he/she will be asked to electronically document the reason the CDS is not being
followed. All patients who test positive for an STI will be notified of their
results and provided treatment based on each site's standard clinical processes for
result notification and treatment.
