An interventional study of Comprehensive Geriatric Assessment arm and EDPLUS in Old Age; Debility and Health Services for the Aged, sponsored by University of Limerick. Completed at 1 site in Ireland. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2022-07-27.
Sponsored by University of Limerick · Not applicable, Interventional, and Treatment
ED PLUS Emergency Department Discharge Physiotherapy Led Community Service is a pilot feasibility randomized controlled trial investigating the role of an integrated care intervention consisting of comprehensive geriatrics assessment in older adults in the emergency department and a physiotherapy-led community based intervention.
All patients who are aged 65 years and over will be screened using the Identification of Seniors at Risk (ISAR) Tool in the emergency department of a University Teaching Hospital. Those with a score of 2 or above in the ISAR and suitable for discharge home will be randomised. The first treatment arm will undergo geriatric medicine item directed Comprehensive Geriatric Assessment (CGA) from admission to emergency department (ED). The non-treatment arm will under usual patient care. The second treatment arm will undergo geriatric medicine team directed CGA from admission to ED and a physiotherapy led community based 6 week intervention in the patient's home. A dedicated multidisciplinary team of geriatric medicine trainee, occupational therapist, physiotherapist and medical social worker will carry out the assessment. For those randomised to the second treatment arm, a physiotherapist will assess and carry out a 6 week interventions that arise from that assessment and liaise with the patients General Practitioner (GP), medical social worker and other health care professionals. The overall aims of ED PLUS are assess the feasibility of the 6 week physiotherapy led intervention. Feasibility will be determined by the following outcomes:
i) Recruitment rate
ii) Adherence rate
iii) Acceptability of the programme
iv) Retention
v) Incidents
The secondary aims are to improve function, reduce anxiety and depression, improve quality of life and prevent unnecessary ED admission.
1,229 studies on the registry are indexed under Frailty; 433 are open to participants now.
This study's enrollment of 29 is below the median of 80 across 704 interventional studies indexed under Frailty.
Browse Frailty studies →University of Limerick is the lead sponsor of 60 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The inclusion criteria for participants include:
Exclusion criteria include:
The usual care control group receives conventional care in the Emergency Department (ED) or Acute Medical Assessment Unit (AMAU)The comparison group will receive routine care as would be usual in the ED or AMAU. Currently there is no dedicated team to perform CGA in the ED and AMAU at UHL with ad hoc allied health assessment available only at the discretion of the referring ED doctor or medical team. This process will be continued during the study and will be documented. The participants in this group will under baseline data collection prior to randomisation and follow up.
The intervention will comprise initially of a detailed interdisciplinary assessment and intervention by one or more members of the dedicated geriatric team. The team (consisting of a geriatric specialist registrar, specialist geriatric nurse, senior pharmacist, senior physiotherapist, senior occupational therapist, and senior medical social worker) in both ED and AMAU will assess all participants in the intervention group and perform CGA. Potential participants will be approached regarding trial recruitment post ED triage thereby ensuring rapid assessment shortly after hospital arrival by the teams in both AMAU and in ED.
Other: Comprehensive Geriatric Assessment arm
The ED PLUS intervention will comprise initially of a detailed interdisciplinary assessment and intervention by one or more members of the dedicated geriatric team. The team in both ED and AMAU will assess all participants in the intervention group and perform CGA. Potential participants will be approached regarding trial recruitment post ED triage thereby ensuring rapid assessment shortly after hospital arrival by the teams in both AMAU and in ED. Additionally the participants in this arm will undergo a 6 week physiotherapy led intervention in the community involving 3 home visits and weekly telephone support. The intervention will involved assessment of the patients function in terms of strength, balance and mobility. Following assessment the intervention will be aimed at addressing deficits in the function of the participants, review of their medical management by a geriatrician trainee and focusing on self management of their own program.
Other: EDPLUS
The intervention will involve a comprehensive geriatric assessment which will be provided by a geriatric doctor, physiotherapist, occupational therapist, social worker, pharmacist and specialist nurse.,
EDPLUS involves a 6 week physiotherapy led community based intervention involving 3 home visits and weekly telephone support.
Functional Decline
Barthel Index is global measure of functional status with a score from 0-20. A score of 0 is completely dependent, 20 is fully independent.
Time frame: 6 weeks post ED visit
Functional Decline
Barthel Index is global measure of functional status with a score from 0-20. A score of 0 is completely dependent, 20 is fully independent.
Time frame: 6 months post ED visit
Patient Quality of Life
Patient rated quality of life is determined by the Euro Quality of Life EQ5D. This scale is scored from 0 to 100 where 0 is the worst imaginable health state with 100 being the best imaginable.
Time frame: Baseline, 6 weeks post ED visit and 6 months post ED visit
Patient satisfaction
Patient satisfaction is determined by the Patient Satisfaction Survey III Short Form (PSQ18). This is scored from 18 to 90, with 18 being the lowest level of satisfaction to 90 being the best score
Time frame: Baseline, 6 weeks post ED visit and 6 months post ED visit
Rate of ED representation
A record of the patient coming back to the ED within 6 weeks and/or 6 months post ED index visit
Time frame: Baseline, 6 weeks post ED visit and 6 months post ED visit
Rate of Hospital readmission
A record of the patient requiring admission to the hospital within 6 weeks and/or 6 months
Time frame: Baseline,6 weeks post ED visit and 6 months post ED visit
Mortality
A record of the patient having died within 6 weeks or 6 months
Time frame: 6 weeks post ED index visit or 6 months post ED index visit
Patient Experience Times
Exact time of admission or discharge form the ED will be collected at 6 weeks post ED index visit
Time frame: 6 weeks
Number of visits to the family doctor or public health nurse
Determined by self reported visits to family doctor or public health nurse. This will be a telephone consultation at 6 week and 6 months post ED index visit where patients will be asked if they have visited a family doctor or public health nurse in the previous 6 weeks at the 6 week telephone call, or 6 months at the 6 month telephone call
Time frame: 6 weeks and 6 months post index ED visit
Plan to share: Yes — Individual data will be stored on a data repository after the study analysis.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: The study protocol will be prepared for publication in an open access journal. The protocol will include the Statistical Analysis plan, detailed descriptions of interventions. It is likely to be published in September 2021
Access criteria: Supporting information will be available on peer review publications.
Ran from Sep 2021 to primary completion in Jun 2022, 9 months.
Of 477 non-industry interventional studies with no phase under Frailty, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 40. This study's 9 months is below that.
Counting every sponsor, half of 484 studies reached it within 21 months; a quarter within 9 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Limerick