Frequent Users of Emergency Department (FUEDs) Clinical Trial
Official title:
Implementing a Case Management Intervention for Frequent Users of the Emergency Department: An Effectiveness-Implementation Hybrid Trial Study Protocol
Background. Emergency department (ED) overcrowding represents a significant public health problem in developed countries. Frequent users of the emergency departments (FUEDs; reporting 5 or more ED visits in the past year) are often affected by medical, psychological, social, and substance use problems and account for a disproportionately high number of ED visits. Past research indicates that the case management (CM) intervention is a promising way to reduce ED overcrowding and improve FUEDs' quality of life. There is, however, very limited knowledge about how to disseminate and implement this intervention on a large scale to diverse clinical settings, including community hospitals and non-academic centers. This research project aims to implement a CM intervention tailored to FUEDs in the public hospitals with ED in the French-speaking region of Switzerland and to evaluate both the implementation process and effectiveness of the CM intervention. Methods. This research project will examine both implementation and clinical outcomes. The implementation part of the study will describe quantitatively and qualitatively factors that influence the implementation process; the investigators will also examine implementation effectiveness (i.e., whether the implementation of the CM intervention in the ED was successful or not). The clinical part of the study will evaluate participants' trajectories on clinical variables (e.g., quality of life, ED use) after receiving the CM intervention. Discussion. This research project will contribute to implementation science by providing key insights into the processes for implementing CM into broader practice. This research project is also likely to have both clinical and public health implications.
Frequent users of the emergency departments (FUEDs) and other health care services are of
much interest to clinicians, administrators and researchers. Emergency department (ED)
overuse is linked to ED overcrowding, which in turn has a negative impact on patients and
health system outcomes. There are over 1.4 million annual ED visits in Switzerland, with 84%
of EDs reporting overcrowding. FUEDs made up 4.4% of the patient population and made 12.1% of
all visits at the Lausanne University Hospital ED. Driving this high use of health care
services is the fact that FUEDs often suffer from chronic medical diseases, including heart
disease, pulmonary disease and cancer, at high rates, in addition to mental illness and
substance use disorders. CM has been shown to be a promising intervention to reduce ED
overuse by frequent users in research settings; however, there is limited knowledge about how
to disseminate and implement a CM intervention for FUEDs on a large scale to diverse clinical
settings, including community hospitals and non-academic centers.
The research project has the following three specific aims:
1. Develop and disseminate a practical CM intervention for FUEDs to several hospitals in
the French-speaking region of Switzerland.
2. Study the process of implementation of the intervention.
3. Study FUEDs' trajectories on health outcomes (e.g., ED use, health care reorientation
and quality of life) after receiving the CM intervention.
This research project is an observational study with a hybrid study design, measuring both
implementation variables and clinical outcomes relating to the dissemination and
implementation of the CM intervention. The implementation part of the study uses a mixed
methods design (i.e., using both qualitative and quantitative analyses) to describe both
qualitatively and quantitatively factors that may influence implementation process. The
clinical part of the study uses a within-subject (pre-post intervention) design to evaluate
participants' trajectories after receiving the CM intervention.
The whole research project will take place over five phases.
Phases 1-2. Development and exploration Procedures. The I-CaM research team will develop the
CM Toolkit, the implementation program, the team member selection-support materials and the
informational announcement to be disseminated to hospitals in the French-speaking region of
Switzerland. Specifically, the research team will develop and send by email a survey aiming
to gauge interest and needs regarding the CM intervention to all eligible hospitals (to key
staff, Chief of Emergency Department). The I-CaM research team will follow up with more
information about the CM intervention and the study procedures. Then, interested parties will
participate in a one-day workshop at Lausanne University Hospital, during which key staff
will receive training on the CM intervention, on the implementation science and on the study
procedures in general. Following the workshop, all sites agreeing to participate will a) be
included in the study and b) complete a questionnaire and participate in a semi-structured
interview (assessing implementation outcomes). Further, the same assessment will be conducted
with hospitals not interested in participating in the study, in face-to-face or by phone and
mail depending upon possibilities (i.e., disinterest analysis).
Phase 3. Preparation Procedures. Included sites will then prepare for implementation of the
CM intervention; sites will first identify CM intervention team members, including
strategical and operational champions and clinicians. Whereas the strategical champion (i.e.,
leader) will promote and hold the implementation project, the operational champion will
support its implementation and application and supervise clinicians who will be in charge of
the CM intervention administration. Next, available resources will be established at each
source and data collection and storage systems will be finalized to gather data on health
service and implementation outcomes by the research team. The I-CaM research team will also
conduct trainings for the CM team to relevant local staff. Finally, at the end of the
preparation phase, champions and clinicians involved in the project on-site will complete a
questionnaire.
Phase 4. Operation The operation phase. The CM intervention will be implemented at all sites
included in the study. At each site, patients fulfilling the inclusion criteria will be
contacted by the case managers. The number of participants included will depend upon each
site resources. If possible (depending upon resources on each site), eligible patients having
been treated in the ED in the 10 days prior the recruitment window will be contacted by phone
and proposed to come back to the ED to participate in the study. Remaining FUEDs (i.e., the
FUEDs not invited to participate in the study) will receive usual care. When first meeting
the participant, the case managers will present the study and examine the exclusion
criterion. If the patient does not have any exclusion criteria and is interested in
participating, the case managers will conduct the informed consent process. After providing
written consent, participants will receive the CM intervention. After each inclusion on site,
the case managers will up-date the I-CaM research team in charge of the clinical assessment
(i.e., baseline and follow-up assessments of the clinical variables to describe participants'
trajectories). The I-CaM research team will contact participants and conduct the baseline
assessment within 10 days following the inclusion. Participants will then complete follow-up
assessments at 3, 6 and 12 months post-baseline. Other clinical variables will be directly
extracted from medical records on-site by the I-CaM research team. At the end of the
operation phase, the research team will conduct semi-structured interviews with case managers
and champions. Both champions and case managers will also complete a questionnaire.
Phase 5. Sustainability Procedures. Following the implementation of the CM intervention, the
sites will continue the CM programs at their discretion. The I-CaM research team will monitor
the activity at each site and will be available for as-needed support to all sites. Clinical
outcomes (i.e., ED use, quality of life, etc.) will not be measured over this finale phase.
At the end of the sustainability phase, the research team will conduct a semi -structured
interview with clinicians and champions. Both champions and clinicians will also complete a
survey.
- The development and exploration phases (no patient recruited) started in August 2017 and
will end in September 2018.
- The preparation phase (no patient recruited) started in March 2018 and will end in
December 2018.
- The operation phase (patients' recruitment start; assessment of health-related outcomes)
will start in October 2018 and end in April 2019.
- The sustainability phase (patients receive the CM intervention but health-related
outcomes are not assessed) will start in April 2019 and end in November 2020.
Data Analysis Plan Implementation measures analysis. Descriptive statistics will be used to
describe participants' characteristics and to report implementation outcomes. The
investigators will also test implementation measure changes over time. Given the expected
small sample size regarding implementation outcomes, these analyses will be triangulated with
qualitative data. Specifically, interview contents will be transcribed and explored to
identify participants' recurring codes and categories; the investigators will use
conventional content analysis (i.e., a systematic process of coding and classification) [1]
using a qualitative software (i.e., Atlas.ti or NVivo) to examine qualitative data.
Clinical outcomes. Data will be screened for missing cases, outliers, and normality of
distributions using descriptive statistics and plots. The investigators will take appropriate
steps to deal with missing data. First, they will conduct analyses to detect missingness
patterns and test whether they may be considered "ignorable."[2] If more than 5% of outcome
data are missing,[3] the sample will be divided into 2 groups (i.e., missing, not missing),
and fully observed variables to predict missingness on the affected outcome will be used. If
fully observed variables are not significant predictors, missingness may be considered as
"observed at random" and fulfilling some criteria for "missing completely at random" (MCAR)
assumptions. In that case, the investigators will use multiple imputations procedures for
measured outcomes and direct maximum likelihood estimation for structural models. If data
missingness is non ignorable (MNAR), pattern-mixture models with multiple imputation to model
the missingness mechanism will be used.
Main analyses will comprise multilevel models (i.e., MLM; mixed effects model) [4] utilizing
appropriate distributions for the outcome variables (e.g., Poisson, negative binomial,
normal). MLM examine the effect of time (after receiving the CM intervention) on clinical
outcomes (e.g., quality of life, self-efficacy). MLM is appropriate to handle nonindependence
data. Specifically, data will be clustered by participants (i.e., repeated measures) and by
hospitals. MLM does not assume independence of observations. Dependence is modeled through
random effects (representing different sources of variability in the data). The investigators
will include sources of random variability at the group level accounting for between-group
differences and another random effects for the individual accounting for within-person
differences in the repeated measures. MLM will be adjusted for demographic variables (i.e.,
age and gender), health-care utilization (including ED use), at-risk behaviors (e.g., alcohol
use disorders) and health status. Descriptive statistics will be conducted on SPSS and MLM on
STATA. The significance level will be set at p = .05.
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