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

NCT04983602 | Completed DMC

• 1 other identifier: EDPLUS
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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 intervention.

Conditions

Old Age; Debility; Health Services for the Aged

Keywords

older adults; geriatric medicine; integrated care; emergency department; feasibility

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (7)

• Patient Quality of Life

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

• Patient satisfaction

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

• Rate of ED representation

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

• Rate of Hospital readmission

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

• Mortality

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

Study Arms (3)

Usual care Control group

NO INTERVENTION

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.

Comprehensive Geriatric assessment arm

EXPERIMENTAL

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

EDPLUS arm

EXPERIMENTAL

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

Interventions

Comprehensive Geriatric Assessment arm OTHER

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.,

Comprehensive Geriatric assessment arm

EDPLUS OTHER

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

EDPLUS arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Limerick: lead
• University Hospital of Limerick: collaborator

Study Sites (1)

University Hospital Limerick

Limerick, Ireland

Location

Related Publications (1)

• 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.

  PMID: 37901478 DERIVED

Related Links

• Peer reviewed protocol
• shared link

MeSH Terms

Conditions

Frailty; Emergencies

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Rose Galvin, PhD

  University of Limerick

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be unaware if the participant was in usual care, comprehensive geriatric assessment arm or the ED PLUS arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 30, 2021
• Study Start: September 13, 2021
• Primary Completion: June 13, 2022
• Study Completion: June 13, 2022
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.

Locations

IE (1)