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

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.

Study Overview

• Status: Completed
• Conditions: Old Age; Debility; Health Services for the Aged
• Intervention / Treatment: Other: Comprehensive Geriatric Assessment arm; Other: EDPLUS

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:

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Limerick, Ireland
    • University Hospital Limerick

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

The inclusion criteria for participants include:

• Adults aged ≥65 years with undifferentiated medical complaints presenting to an ED.
• Medically stable as deemed by the treating physician
• Display a score of ≥2 on the Identification of Seniors at Risk (ISAR) screening tool.
• Be community dwelling
• Be discharged from the ED within 72 hours of index visit.

Exclusion criteria include:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care Control group; 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.
Experimental: Comprehensive Geriatric assessment arm; 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 intervention will involve a comprehensive geriatric assessment which will be provided by a geriatric doctor, physiotherapist, occupational therapist, social worker, pharmacist and specialist nurse.,
Experimental: EDPLUS 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; EDPLUS involves a 6 week physiotherapy led community based intervention involving 3 home visits and weekly telephone support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 months post ED visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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	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	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	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	6 weeks and 6 months post index ED visit

Collaborators and Investigators

• Sponsor: University of Limerick
• Collaborators: University Hospital of Limerick
• Investigators: Principal Investigator: Rose Galvin, phD, University of Limerick

Publications and helpful links

Helpful Links

• Peer reviewed protocol
• shared link

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2021
• Primary Completion (Actual): June 13, 2022
• Study Completion (Actual): June 13, 2022

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: July 21, 2021
• First Posted (Actual): July 30, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: older adults; geriatric medicine; feasibility; emergency department; integrated care
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Frailty
• Other Study ID Numbers: EDPLUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual data will be stored on a data repository after the study analysis.
• IPD Sharing 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
• IPD Sharing Access Criteria: Supporting information will be available on peer review publications.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No