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Old Age; DebilityEDPLUSNCT04983602

Physiotherapy Led Community Intervention for Older Adults Discharged From the Emergency Department

A study testing Comprehensive Geriatric Assessment arm and EDPLUS in people with Old Age; Debility and Health Services for the Aged, run by University of Limerick at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Comprehensive Geriatric Assessment arm and EDPLUS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteIreland
Study dates
13 Sep 2021to 13 Jun 2022
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

None listed.

Who cannot join

  • Individuals under the age of 65 years.
  • Have a score of less than 2 on the ISAR.
  • Older adults who present with acute myocardial infarction, stroke or non-medical problems e.g. surgical or psychiatric issues.
  • Older adults who are medically unstable will be excluded.
  • If neither the patient nor carer can communicate in English sufficiently to complete consent or baseline assessment, they will be excluded.
  • Older adults who are admitted to hospital from the ED will be excluded.
  • Older adults who have a confirmed COVID 19 diagnosis or those with symptoms highly suggestive of COVID 19 will be excluded.

Trial locations and contacts

1 site in 1 country.

Ireland1 site

  • University Hospital Limerick

    Limerick

Other trials in Ireland

About this study

Official title: The Effectiveness of a Physiotherapy Led Community Based Intervention at Reducing Adverse Outcomes in Older Adults Discharged From the Emergency Department: A Pilot Feasibility Randomized Controlled Trial

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.

Read the detailed description

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:

  1. Recruitment rate ii) Adherence rate iii) Acceptability of the programme iv) Retention
  2. Incidents

The secondary aims are to improve function, reduce anxiety and depression, improve quality of life and prevent unnecessary ED admission.

Being tested
Comprehensive Geriatric Assessment arm, EDPLUS
Keywords
older adults, geriatric medicine, integrated care, emergency department, feasibility
Medical subject headings
Frailty, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Comprehensive Geriatric Assessment armOther

    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.,

  • EDPLUSOther

    EDPLUS involves a 6 week physiotherapy led community based intervention involving 3 home visits and weekly telephone support.

Study groups in NCT04983602
Study groupRoleWhat they receive
Usual care Control groupNo interventionThe 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.
Comprehensive Geriatric assessment armExperimentalThe 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.
Receives: Other: Comprehensive Geriatric Assessment arm
EDPLUS armExperimentalThe 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.
Receives: Other: EDPLUS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 weeks post ED visit

  2. 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.

    Measured: 6 months post ED visit

Secondary outcomes (7)

  1. 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.

    Measured: Baseline, 6 weeks post ED visit and 6 months post ED visit

  2. 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

    Measured: Baseline, 6 weeks post ED visit and 6 months post ED visit

  3. 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

    Measured: Baseline, 6 weeks post ED visit and 6 months post ED visit

  4. Rate of Hospital readmission

    A record of the patient requiring admission to the hospital within 6 weeks and/or 6 months

    Measured: Baseline,6 weeks post ED visit and 6 months post ED visit

  5. Mortality

    A record of the patient having died within 6 weeks or 6 months

    Measured: 6 weeks post ED index visit or 6 months post ED index visit

  6. Patient Experience Times

    Exact time of admission or discharge form the ED will be collected at 6 weeks post ED index visit

    Measured: 6 weeks

  7. 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

    Measured: 6 weeks and 6 months post index ED visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2021
  2. Study start13 Sep 2021
  3. Primary completion13 Jun 2022
  4. Study completion13 Jun 2022

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04983602
Sponsor's protocol ID
EDPLUS
Acronym
EDPLUS
Status last verified
Jul 2022
First submitted
23 Jun 2021
Last updated
27 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual data will be stored on a data repository after the study analysis.

Publications

  • Conneely M, Leahy S, O'Connor M, Corey G, Gabr A, Saleh A, Okpaje B, O' Shaughnessy I, Synnott A, McCarthy A, Holmes A, Robinson K, Ryan L, Griffin A, Barry L, Trepel D, Ryan D, Galvin R; Ageing Research Centre Public and Patient Involvement (PPI) Panel of older adults. A Physiotherapy-Led Transition to Home Intervention for Older Adults Following Emergency Department Discharge: A Pilot Feasibility Randomised Controlled Trial (ED PLUS). Clin Interv Aging. 2023 Oct 24;18:1769-1788. doi: 10.2147/CIA.S413961. eCollection 2023.

    PubMed 37901478

Questions about this trial

What is this clinical trial studying?

A study testing Comprehensive Geriatric Assessment arm and EDPLUS in people with Old Age; Debility and Health Services for the Aged, 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 0 inclusion and 7 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: finished, as of the sponsor's last update on 27 Jul 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Functional Decline (time frame: 6 weeks post ED visit). The study lists 2 primary outcomes in all. 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 NCT04983602, which also lists 1 linked publication.

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 27 Jul 2022.

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