ED-based Allied Health Services Clinical Trial
Official title:
A Pilot Randomised Controlled Trial Exploring the Impact of a Dedicated Health and Social Care Professionals (HSCP) Team in the Emergency Department on the Quality, Safety and Cost-effectiveness of Care for Older Adults
The study aims to examine the impact of implementing a dedicated team of Health and Social
Care Professionals (HSCPs) in the emergency department (ED) of a large Irish hospital on the
quality, safety and cost-effectiveness of care for older adults (aged ≥65). Early assessment
and intervention provided by the HSCP team will be compared to routine ED care to explore
potential benefits related to key ED outcomes, including length of stay as well as hospital
admissions and patient satisfaction/quality of life.
This study is part of an ongoing interdisciplinary project funded by the Health Research
Board of Ireland through the Research Collaborative on Quality and Patient Safety (RCQPS)
Grant Call 2017. The project is led by Dr Rose Galvin, Senior Lecturer in Physiotherapy at
the University of Limerick (UL, Ireland), and overseen by an interdisciplinary steering group
of expert researchers and clinicians in Emergency Medicine and Allied Health.
Background Internationally, emergency departments (EDs) face significant challenges in
delivering high quality and timely patient care on an ever-present background of increasing
patient numbers and limited hospital resources. Research demonstrates that ED crowding
contributes to a reduction in the quality of patient care, delays in commencement of
treatment and that adherence with recognised clinical guidelines worsens [1].
Identifying quality improvement strategies to improve patient flow in the ED can enhance
quality of care. Evidence from international studies demonstrates that Health and Social Care
Professionals (HSCPs) such as physiotherapists, occupational therapists and medical social
workers can play a role in the ED in reducing length of patient stay, avoiding unnecessary
hospital admissions and improving patient experience [2,3]. However, the quality of the
evidence is mixed, primarily due to weaknesses in designing the studies.
Aim The overall aim of the study is to examine the impact of a dedicated team of Health and
Social Care Professionals (HSCPs) in the Emergency Department (ED) on the quality, safety and
cost-effectiveness of care of older adults in the ED.
The objectives of the study are as follows:
1. To implement a HSCP team including a whole time equivalent senior physiotherapist (PT),
senior occupational therapist (OT) and senior medical social worker (MSW) in the
Emergency Department at University Hospital Limerick (UHL) for a period of six months.
2. To examine if early assessment and intervention by the HSCP team improves the quality,
safety and cost-effectiveness of care among older adults who present to the ED, as
compared to usual care.
3. To conduct a process evaluation of the HSCP intervention through focus group interviews
with the HSCP team and representation from the wider ED staff regarding the
implementation, delivery and impact of the intervention.
Methods
Study design The study represents a pilot randomised controlled trial which will compare
assessment and/or interventions carried by a HSCP team, comprised of a physiotherapist, an
occupational therapist and a medical social worker, in the ED with usual ED care. The
Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines will be followed to
ensure the standardised conduct and reporting of the research.
Population All adults ≥65 years who present to the Emergency Department at University
Hospital Limerick (UHL) between December 2018 and March 2019 (inclusive) will be considered
eligible for inclusion to the study provided that they meet the inclusion criteria (see
below). However, similar to other studies, the HSCP team is operational between the hours of
8am and 5pm Monday-Friday. Therefore, individuals who present outside of these hours may not
be offered/included in the study.
Consent Potential participants will initially be informed of the study by the triage nurse or
the treating physician. If participants indicate a willingness to hear more about the study,
the dedicated research nurse on the project will be informed. The research nurse will
subsequently meet with the potential participant and describe the study in detail and provide
potential participants with an information leaflet. Participants will be given the
opportunity to ask further questions about the project should they wish to do so. Written
informed consent will be obtained by the research nurse if/when the participant indicates
their willingness to formally participate in the study. Participants will have the duration
of their index admission to consider participation in the study. Consent and mechanisms
relating to data controlling and processing will be compliant with the European Union (EU)
General Data Protection Regulation (GDPR) 2016/679 and also in compliance with the Data
Protection Act 2018 [(Section 36(2)) (Health Research) Regulations 2018].
Intervention The intervention will comprise initially of a detailed assessment by one or more
members of the dedicated HSCP team (physiotherapy, occupational therapy and medical social
work). The assessment will include but not be limited to an assessment of mobility and
stairs, transfer, personal care, activities of daily living (ADLs), social supports,
cognition, lying & standing blood pressures. Members of the HSCP team will be guided by their
clinical expertise and codes of professional practice. Similarly, interventions prescribed by
the HSCP team will be based on subjective and objective assessment of patients and will
include mobility aids, exercise programmes, ADL equipment and onward referral as appropriate.
All assessments and interventions will be included in the medical chart of individual
participants.
Comparison The comparison group will receive routine care for the duration of their stay in
the ED. Currently there is no dedicated team of HSCPs in the Emergency Department at UHL.
Ad-hoc services are provided by allied health professionals if they are requested by a member
of the team in the ED. This process will continue for the duration of the trial.
Outcomes and analysis The primary outcome of the study is duration of patient ED stay (mean
hours from time of arrival to discharge or admission). Secondary outcomes will include the
incidence of inpatient admission from the ED (defined as the proportion of patients who are
admitted to hospital after their index visits), the duration of hospital admission after the
ED index visit, as well as the number of ED re-attendances, nursing home admissions,
unplanned hospital visits (and duration of stay) and mortality within 30 days, four months
and six months of the initial index visit. Healthcare utilisation (visits to GP, public
health nurse, home help, private consultations, outpatient department visits, or allied
health services) will also be captured at 30 days, four months and six months. Assessment of
patient oriented outcomes include the Barthel Index for Activities of Daily Living (17) as a
global measure of function and the EuroQoL's 5-Dimension 5-Level (EQ-5D-5L) to measure
health-related quality of life (18), which will be conducted at baseline as well as at
follow-up (30 days and six months, with quality of life also assessed at four months).
In addition, patient satisfaction with their index visit will be explored using the 18-item
Patient Satisfaction Questionnaire (PSQ-18) (19) at the time of the visit.
An economic analysis will estimate the incremental cost effectiveness of the HSCP team from
the perspective of the Irish public health service, as compared to usual care. We will
estimate health care costs from reference costs from national data sources. Participants'
responses to the EQ-5D-5L questionnaire will be used to estimate health states utilities
using the Irish value set (20) and Quality-Adjusted Life Years (QALYs) for each treatment
group will be estimated across all timepoints.
Lastly, a process evaluation will be conducted through a mixed quantitative-qualitative
design to describe the implementation of the intervention as well as investigate the
mechanisms and contextual influences of the implementation as perceived by the HSCP team and
representation from the wider ED staff. A detailed study protocol for the process evaluation
is in preparation.
Each participant in the study will be assigned a numerical code in order to link data
collected at baseline to the data collected at follow-up at 30 days, four and six months.
Aggregate data will be anonymised. Appropriate descriptive statistics will be used to
describe the baseline characteristics of study participants. These will include proportions,
percentages, ranges, means and standard deviations and medians and interquartile ranges
(where data are not normally distributed). We will analyse differences across the two groups
for all continuous outcomes (ED length of stay, etc.) by using independent samples t-tests
with 95% CI. The non-parametric equivalent will be used for skewed data. Incidence of ED
return, unplanned hospital admission, nursing home admission and healthcare utilization will
be explored using crude and adjusted risk ratios with associated 95% Confidence Interval
(CI).
Considering the cost-effectiveness analysis, as per the Irish Health Information and Quality
Authority (HIQA) guidance (21), the primary endpoint of the cost-effectiveness analysis will
be costs, QALYs and the Incremental Cost Effectiveness Ratio (ICER). Analysis of uncertainty
of the joint distribution of cost and QALYs between the two arms of the study will be
presented on a cost-effectiveness acceptability curve to indicate the probability that the
HSCP intervention will be cost effective, based on available trial data and across various
willingness to pay thresholds.
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