ED-based Allied Health ServicesNCT03739515
Impact of an Allied Health Team in the Emergency Department on Older Adults' Care
A study testing HSCP intervention and ED routine care in people with ED-based Allied Health Services, run by University of Limerick at 1 site in Ireland.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- ED-based Allied Health Services
- What is being tested?
- HSCP intervention and ED routine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 1 siteIreland
- Study dates
- 3 Dec 2018to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ≥65 years
- Medically stable (treating physician)
- Off baseline mobility
- Capacity (Mini Mental State Examination score ≥17) and willingness to provide informed consent
- Presenting during HSCP operational hours (8am-5pm Monday-Friday)
Who cannot join
- Under 65 years
- Medically unstable
- Neither the patient nor the carer can communicate in English sufficiently to complete consent or baseline assessment
- Present outside HSCP operational hours.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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:
- 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.
- 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.
- 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.
- Conditions
- ED-based Allied Health Services
- Being tested
- HSCP intervention, ED routine care
- Keywords
- Emergency department, Health and Social Care Professional, Team care, Older patients, Effectiveness
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSCP interventionOther
A team of HSCPs (physiotherapist, occupational therapist, medical social worker) will provide comprehensive functional assessment to older patients
ED routine careOther
ED staff including consultants and nurses will provide patients with routine ED medical care.
| Study group | Role | What they receive |
|---|---|---|
| HSCP team | Experimental | Patients in this arm will receive comprehensive assessment and/or pre-discharge services by an ED-based HSCP team Receives: Other: HSCP intervention |
| Routine care | Active comparator | Patients in this arm will receive routine ED care Receives: Other: ED routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
ED length of stay
Hours from ED admission to discharge
Measured: 1-24 hours (one day) after accessing the ED
Secondary outcomes (10)
Incidence of Representations
Percentages of patients who experience ED revisits, unplanned hospital visits or nursing home admissions after the ED index visit
Measured: 30 days, four months, and six months after index visit
Incidence of Healthcare utilization
Percentages of patients who visit a general practitioner (GP), a public health nurse, outpatient departments, private consultations, home help, or allied health services after the ED index visit
Measured: 30 days, four months, and six months after index visit
Functional status
Patient global functioning as measured through the Barthel Index of Activities of Daily Living.
The Barthel Index is a 10-item scale used to assess functional independence. The scoring varies across items:
- bowels, bladder, toilet use, feeding, dressing, and stairs are scored from from 0 (dependence or inability) to 2 (independence)
- grooming and bathing are scored either 0 (dependent or needs help) or 1 (independent)
- transfer and mobility are scored 0 (dependent), 1 (major help), 2 (minor help), or 3 (independent).
The total score ranges from 0 to 20 and it is obtained by adding up the scores of each item. Lower scores indicated increased disability. In case of rehabilitation, changes of more than two points in the total score reflect a probable genuine change, and change on one item from fully dependent to independent is also likely to be reliable.
Measured: Baseline, 30 days and six months after index visit
Patient quality of life
Quality of life assessed through the EuroQoL-5D-5L (EQ-5D-5L). The EQ-5D-5L is a standardised instrument developed by the EuroQoL Group (https://euroqol.org/euroqol/) to measure health-related quality of life.
It includes a descriptive questionnaire assessing 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with 5 levels of self-rated severity (1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, and 5 = extreme problems). Each dimension is scored separately from 0 to 5 and the patient's "health state" is coded as a 5-digit string.
It also includes a vertical visual analogue scale (VAS) to record the patient's self-rated health on a scale from 0 (worst health) to 100 (best health). The score assigned by the patient represents the self-reported level of health.
Measured: Baseline, 30 days, four months and six months after index visit
Patient satisfaction with index visit
Patient satisfaction with the index visit will be assessed using the Patient Satisfaction Questionnaire (PSQ-18) - Short Form.
The PSQ-18 is an 18-item questionnaire that assesses patient's satisfaction with 6 aspects of care: technical quality, interpersonal manner, communication, financial aspects, time spent with the healthcare provider, and accessibility of care. General satisfaction is also assessed.
The items are presented as statements about the experience of care and rated based on the patient's level of agreement with each statement from 1 (strongly agree) to 5 (strongly disagree).
The PSQ-18 yields separate scores for each of seven different dimensions. All items should be scored so that high scores reflect satisfaction with medical care. After item scoring, items within the same sub-scale should be averaged together to create the 7 sub-scale scores.
Measured: At time of index visit
Process evaluation
The level of staff satisfaction and their perceptions on the implementation, delivery and impact of the intervention will be assessed with the HSCP team and other ED staff members (consultants, nurses) using qualitative methodologies (focus groups) after the completion of participant recruitment.
Measured: Within two months after completion of data collection (eight months after beginning of the study)
Cost-effectiveness
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
Measured: Four months after index visit
Nursing home admission
The rates of patients admitted to a nursing home will be captured at follow-up
Measured: 30 days and six months after index visit
Mortality
The rates of patients deceased will be captured at follow-up
Measured: 30 days and six months after the index visit
Hospital admission rate
Percentages of patients admitted to the ward from the ED
Measured: Within 72 hours of ED index visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start3 Dec 2018
- Primary completion30 Nov 2019 (estimated)
- Study completion30 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ED-based Allied Health ServicesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants will be randomly assigned to either the experimental group (ED-based HSCP intervention) or the control group (ED routine care). By assigning participants at random, it is possible to infer that any observed group differences are attributable to the independent variable (the intervention under investigation).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Limerick
- Responsible party
- Sponsor
- Investigators
- Rose Galvin, PhD, Principal investigator, University of LimerickDamien Ryan, PhD, Principal investigator, University Hospital of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739515
- Sponsor's protocol ID
- Optimend_WP4
- Status last verified
- Sep 2019
- First submitted
- 7 Nov 2018
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared with other researchers
Publications
Carter EJ, Pouch SM, Larson EL. The relationship between emergency department crowding and patient outcomes: a systematic review. J Nurs Scholarsh. 2014 Mar;46(2):106-15. doi: 10.1111/jnu.12055. Epub 2013 Dec 19.
PubMed 24354886Arendts G, Fitzhardinge S, Pronk K, Hutton M. Outcomes in older patients requiring comprehensive allied health care prior to discharge from the emergency department. Emerg Med Australas. 2013 Apr;25(2):127-31. doi: 10.1111/1742-6723.12049. Epub 2013 Feb 19.
PubMed 23560962Cassarino M, Robinson K, Quinn R, Naddy B, O'Regan A, Ryan D, Boland F, Ward ME, McNamara R, McCarthy G, Galvin R. Effectiveness of early assessment and intervention by interdisciplinary teams including health and social care professionals in the emergency department: protocol for a systematic review. BMJ Open. 2018 Jul 16;8(7):e023464. doi: 10.1136/bmjopen-2018-023464.
PubMed 30012796Trepel D, Ruiz-Adame M, Cassarino M, Ahern E, Devlin C, Robinson K, O'Shaughnessy I, McCarthy G, Corcoran C, Galvin R. The cost effectiveness of early assessment and intervention by a dedicated health and social care professional team for older adults in the emergency department compared to treatment-as-usual: Economic evaluation of the OPTI-MEND trial. PLoS One. 2024 Jun 25;19(6):e0298162. doi: 10.1371/journal.pone.0298162. eCollection 2024.
PubMed 38917081Cassarino M, Cronin U, Robinson K, Quinn R, Boland F, Ward ME, McNamara R, O'Connor M, McCarthy G, Ryan D, Galvin R. Development and delivery of an allied health team intervention for older adults in the emergency department: A process evaluation. PLoS One. 2022 May 26;17(5):e0269117. doi: 10.1371/journal.pone.0269117. eCollection 2022.
PubMed 35617330Cassarino M, Robinson K, Trepel D, O'Shaughnessy I, Smalle E, White S, Devlin C, Quinn R, Boland F, Ward ME, McNamara R, Steed F, O'Connor M, O'Regan A, McCarthy G, Ryan D, Galvin R. Impact of assessment and intervention by a health and social care professional team in the emergency department on the quality, safety, and clinical effectiveness of care for older adults: A randomised controlled trial. PLoS Med. 2021 Jul 28;18(7):e1003711. doi: 10.1371/journal.pmed.1003711. eCollection 2021 Jul.
PubMed 34319971Griffin A, O'Neill A, O'Connor M, Ryan D, Tierney A, Galvin R. The prevalence of malnutrition and impact on patient outcomes among older adults presenting at an Irish emergency department: a secondary analysis of the OPTI-MEND trial. BMC Geriatr. 2020 Nov 7;20(1):455. doi: 10.1186/s12877-020-01852-w.
PubMed 33160319Cassarino M, Robinson K, O'Shaughnessy I, Smalle E, White S, Devlin C, Quinn R, Trepel D, Boland F, Ward ME, McNamara R, O'Connor M, McCarthy G, Ryan D, Galvin R. A randomised controlled trial exploring the impact of a dedicated health and social care professionals team in the emergency department on the quality, safety, clinical and cost-effectiveness of care for older adults: a study protocol. Trials. 2019 Oct 15;20(1):591. doi: 10.1186/s13063-019-3697-5.
PubMed 31615573Cassarino M, Cronin U, Robinson K, Quinn R, Boland F, Ward ME, MacNamara R, O'Connor M, McCarthy G, Ryan D, Galvin R. Implementing an allied health team intervention to improve the care of older adults in the emergency department: protocol for a process evaluation. BMJ Open. 2019 Jul 16;9(7):e032645. doi: 10.1136/bmjopen-2019-032645.
PubMed 31315881
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03739515
- Acronym / sponsor ID
- Optimend_WP4
- Conditions
- ED-based Allied Health Services
- Keywords
- Emergency department, Health and Social Care Professional, Team care, Older patients, Effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 354 participants (actual)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Collaborators
- University Hospital of Limerick
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 30 Nov 2019 (estimated)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible participants will be randomly assigned to either the experimental group (ED-based HSCP intervention) or the control group (ED routine care). By assigning participants at random, it is possible to infer that any observed group differences are attributable to the independent variable (the intervention under investigation).
| Arm | Type | Receives |
|---|---|---|
| HSCP team | Experimental | Other: HSCP interventionPatients in this arm will receive comprehensive assessment and/or pre-discharge services by an ED-based HSCP team |
| Routine care | Active comparator | Other: ED routine carePatients in this arm will receive routine ED care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- ≥65 years
- Medically stable (treating physician)
- Off baseline mobility
- Capacity (Mini Mental State Examination score ≥17) and willingness to provide informed consent
- Presenting during HSCP operational hours (8am-5pm Monday-Friday)
Key exclusion criteria (4 listed)
- Under 65 years
- Medically unstable
- Neither the patient nor the carer can communicate in English sufficiently to complete consent or baseline assessment
- Present outside HSCP operational hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSCP interventionA team of HSCPs (physiotherapist, occupational therapist, medical social worker) will provide comprehensive functional assessment to older patients | Other | HSCP team |
| ED routine careED staff including consultants and nurses will provide patients with routine ED medical care. | Other | Routine care |
Primary outcome
ED length of stay
Time frame: 1-24 hours (one day) after accessing the ED
Hours from ED admission to discharge
10 secondary outcomes
Incidence of Representations
Time frame: 30 days, four months, and six months after index visit
Incidence of Healthcare utilization
Time frame: 30 days, four months, and six months after index visit
Functional status
Time frame: Baseline, 30 days and six months after index visit
Patient quality of life
Time frame: Baseline, 30 days, four months and six months after index visit
Patient satisfaction with index visit
Time frame: At time of index visit
Process evaluation
Time frame: Within two months after completion of data collection (eight months after beginning of the study)
Cost-effectiveness
Time frame: Four months after index visit
Nursing home admission
Time frame: 30 days and six months after index visit
Mortality
Time frame: 30 days and six months after the index visit
Hospital admission rate
Time frame: Within 72 hours of ED index visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Background: PubMed 24354886Carter EJ, Pouch SM, Larson EL. The relationship between emergency department crowding and patient outcomes: a systematic review. J Nurs Scholarsh. 2014 Mar;46(2):106-15. doi: 10.1111/jnu.12055. Epub 2013 Dec 19.
- Background: PubMed 23560962Arendts G, Fitzhardinge S, Pronk K, Hutton M. Outcomes in older patients requiring comprehensive allied health care prior to discharge from the emergency department. Emerg Med Australas. 2013 Apr;25(2):127-31. doi: 10.1111/1742-6723.12049. Epub 2013 Feb 19.
- Background: PubMed 30012796Cassarino M, Robinson K, Quinn R, Naddy B, O'Regan A, Ryan D, Boland F, Ward ME, McNamara R, McCarthy G, Galvin R. Effectiveness of early assessment and intervention by interdisciplinary teams including health and social care professionals in the emergency department: protocol for a systematic review. BMJ Open. 2018 Jul 16;8(7):e023464. doi: 10.1136/bmjopen-2018-023464.
- Derived from this study: PubMed 38917081Trepel D, Ruiz-Adame M, Cassarino M, Ahern E, Devlin C, Robinson K, O'Shaughnessy I, McCarthy G, Corcoran C, Galvin R. The cost effectiveness of early assessment and intervention by a dedicated health and social care professional team for older adults in the emergency department compared to treatment-as-usual: Economic evaluation of the OPTI-MEND trial. PLoS One. 2024 Jun 25;19(6):e0298162. doi: 10.1371/journal.pone.0298162. eCollection 2024.
- Derived from this study: PubMed 35617330Cassarino M, Cronin U, Robinson K, Quinn R, Boland F, Ward ME, McNamara R, O'Connor M, McCarthy G, Ryan D, Galvin R. Development and delivery of an allied health team intervention for older adults in the emergency department: A process evaluation. PLoS One. 2022 May 26;17(5):e0269117. doi: 10.1371/journal.pone.0269117. eCollection 2022.
- Derived from this study: PubMed 34319971Cassarino M, Robinson K, Trepel D, O'Shaughnessy I, Smalle E, White S, Devlin C, Quinn R, Boland F, Ward ME, McNamara R, Steed F, O'Connor M, O'Regan A, McCarthy G, Ryan D, Galvin R. Impact of assessment and intervention by a health and social care professional team in the emergency department on the quality, safety, and clinical effectiveness of care for older adults: A randomised controlled trial. PLoS Med. 2021 Jul 28;18(7):e1003711. doi: 10.1371/journal.pmed.1003711. eCollection 2021 Jul.
- Derived from this study: PubMed 33160319Griffin A, O'Neill A, O'Connor M, Ryan D, Tierney A, Galvin R. The prevalence of malnutrition and impact on patient outcomes among older adults presenting at an Irish emergency department: a secondary analysis of the OPTI-MEND trial. BMC Geriatr. 2020 Nov 7;20(1):455. doi: 10.1186/s12877-020-01852-w.
- Derived from this study: PubMed 31615573Cassarino M, Robinson K, O'Shaughnessy I, Smalle E, White S, Devlin C, Quinn R, Trepel D, Boland F, Ward ME, McNamara R, O'Connor M, McCarthy G, Ryan D, Galvin R. A randomised controlled trial exploring the impact of a dedicated health and social care professionals team in the emergency department on the quality, safety, clinical and cost-effectiveness of care for older adults: a study protocol. Trials. 2019 Oct 15;20(1):591. doi: 10.1186/s13063-019-3697-5.
- Derived from this study: PubMed 31315881Cassarino M, Cronin U, Robinson K, Quinn R, Boland F, Ward ME, MacNamara R, O'Connor M, McCarthy G, Ryan D, Galvin R. Implementing an allied health team intervention to improve the care of older adults in the emergency department: protocol for a process evaluation. BMJ Open. 2019 Jul 16;9(7):e032645. doi: 10.1136/bmjopen-2019-032645.
- Individual participant dataSharing planned: No. No individual participant data will be shared with other researchers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rose Galvin, PhD principal investigator
University of Limerick
Damien Ryan, PhD principal investigator
University Hospital of Limerick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HSCP intervention and ED routine care in people with ED-based Allied Health Services, run by University of Limerick at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ED length of stay (time frame: 1-24 hours (one day) after accessing the ED). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03739515, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.