Design
The study represents a single-centre parallel group randomised controlled trial which will compare assessment and/or interventions carried by a HSCP team, comprised of a senior physiotherapist, a senior occupational therapist and a senior medical social worker, in the ED with usual ED care. The CONSORT standardised reporting guidelines will be followed to ensure the standardised conduct and reporting of the research. This protocol has been registered on ClinicalTrials.gov (NCT03739515) and prepared in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines (see Figure 1). The checklist is presented in Additional File 1.
[Figure 1 here]
Setting
The study will take place in the ED of University Hospital Limerick (UHL), a 562-bed regional hospital with a large catchment area in the Western region of the Republic of Ireland. Follow-up assessment will take place via telephone interviews.
Participants
All adults aged ≥65 years who present to the Emergency Department at University Hospital Limerick between December 2018 and May 2019 (inclusive) are considered eligible for inclusion to the study provided that they meet the following inclusion criteria:
- Capacity (MMSE ≥17) and willingness to provide informed consent
- Off baseline mobility and functional status
- Medically stable (where relevant**) and presenting with any of the complaints presented in Table 1, as per Manchester Triage System 2–5 (15).
Table 1 Presenting complaint as per Manchester Triage System (15)
Exclusion criteria:
- Aged under 65 years
- Medically unstable
- Neither the patient nor the carer can communicate in English sufficiently to complete consent or baseline assessment;
- Presentation and discharge outside of HSCP operational hours. Similar to other studies, the HSCP team is operational between the hours of 8am and 5pm Monday-Friday. Therefore, individuals who present to the ED and are discharged outside of these hours will not be included in the study.
This study is pragmatic in nature and to reflect the realities of clinical practice in the ED, both the triage nurses and treating physicians will act as gatekeepers at the UHL site and inform eligible participants about the study. This method is chosen as the medical condition of participants will change over the course of the index admission.
Consent
If participants and carers (where relevant) wish to hear more about the study, the triage nurse/treating physician will inform the dedicated research nurse or a member of the HSCP team who will provide them with an information sheet and further discuss the nature of the project with them. Participants will be offered an opportunity to ask questions about participation in the study. Prospective participants will then be asked to sign a consent form. 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 EU General Data Protection Regulation 2016/679 and also in compliance with the Data Protection Act 2018 [(Section 36(2)) (Health Research) Regulations 2018].
Randomisation
Should participants explicitly consent to participate in the study, they will undergo a baseline assessment of function and quality of life by the research nurse or member of the HSCP team. To minimise the possibility of selection bias, a person independent of the recruitment process will complete random group allocation. Computer generated random numbers will be created and placed in sealed envelopes by this independent person. These numbers will be stored in the pre-sealed envelopes in a locked drawer in the Emergency Department. Allocation will be revealed after recruitment of eligible participants and the conduct of the baseline assessment. Allocation will be revealed by accessing and opening the next envelope in the sequence and providing the randomisation information to the research team and patient simultaneously. Each envelope will be opened on enrolment and baseline assessment of an eligible participant. After allocation is revealed, participants will either receive the HSCP intervention or routine care (control group).
Power calculation
We estimated our sample size based on our primary outcomes (ED length of stay and admission rates). Using data from the Patient Experience Time (PET) database employed in the ED at UHL, the average ED length of stay for patients aged 65 and older for the period 2016–2017 was 14.05 hours (SD = 12.43) and around 52% were admitted to ward after the index visit (16). Estimating a 40% decrease in ED length of stay in the intervention group (7.5 vs. 15.2 median hours) and a 20% decrease in admission rates (30% vs. 50%), and with a 20% attrition rate to follow-up, a sample size of 320 patients (160 in each group) is required to achieve 90% power with two-tailed tests at an alpha level of 0.05.
Experimental and control interventions
Intervention
Participants in the intervention group will be assessed by one or more members of the dedicated HSCP team (physiotherapy, occupational therapy and medical social work). This will include a holistic assessment of mobility, functional, cognitive and psychosocial abilities. Similarly, interventions prescribed by the HSCP team will be based on subjective and objective assessment of patients; individualised discharge care plans will be instituted from the emergency department in order to promote safe, supported discharge home. All assessments and interventions will be included in the medical chart of individual participants and communicated back to the ED team.
Control group
The comparison group will receive routine care for the duration of their stay in the ED. Currently, there is no dedicated team of HSCPs to assess and intervene with older adults who present to the ED at UHL. Ad-hoc services are provided by allied health professionals if they are bleeped by a member of the team in the ED. This process will continue for the duration of the trial and will be recorded.
Outcomes
A range of primary and secondary outcomes will be assessed to identify the potential impact of the intervention on quality, safety, clinical- and cost-effectiveness of care. The primary outcomes of the study are duration of patient ED stay (mean hours from time of arrival to discharge or admission) and the incidence of inpatient admission from the ED (defined as the proportion of patients who are admitted to hospital after their index visits). Secondary outcomes will include 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-Level of the EQ–5D (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.
Data collection and management
Outcome assessment at baseline and at the end of the visit will be conducted by a research nurse blinded to the patient allocation in order to reduce potential detection bias. A chart review will take place by the research nurse to ascertain demographic details. Outcome assessment at follow-up (30 days, 4 months and six months post-index visit) will be conducted via telephone call.
Data Analysis
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% 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.
Monitoring
Participants will be under the medical care of their treating physician for the duration of their ED stay. Participants who are admitted to UHL as an inpatient will be transferred to a relevant ward following their ED stay where their medical care will be transferred to the relevant team. Participants who are discharged from the ED to the community setting or nursing home will be discharged to the care of their GP. The GP will be informed of their participation in the study. Participants may also be referred to community nursing, allied health professionals or community care teams. Once the study is completed, the health of participants will be monitored by their GP or treating physician (if the participant is an inpatient).