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

Primary Purpose

Old Age; Debility, Health Services for the Aged

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Comprehensive Geriatric Assessment arm
EDPLUS
Sponsored by
University of Limerick
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Old Age; Debility focused on measuring older adults, geriatric medicine, integrated care, emergency department, feasibility

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital Limerick

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Usual care Control group

Comprehensive Geriatric assessment arm

EDPLUS arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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
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
Rate of Hospital readmission
A record of the patient requiring admission to the hospital within 6 weeks and/or 6 months
Mortality
A record of the patient having died within 6 weeks or 6 months
Patient Experience Times
Exact time of admission or discharge form the ED will be collected at 6 weeks post ED index visit
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

Full Information

First Posted
June 23, 2021
Last Updated
July 26, 2022
Sponsor
University of Limerick
Collaborators
University Hospital of Limerick
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1. Study Identification

Unique Protocol Identification Number
NCT04983602
Brief Title
Physiotherapy Led Community Intervention for Older Adults Discharged From the Emergency Department
Acronym
EDPLUS
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 13, 2021 (Actual)
Primary Completion Date
June 13, 2022 (Actual)
Study Completion Date
June 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Limerick
Collaborators
University Hospital of Limerick

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Old Age; Debility, Health Services for the Aged
Keywords
older adults, geriatric medicine, integrated care, emergency department, feasibility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The outcomes assessor will be unaware if the participant was in usual care, comprehensive geriatric assessment arm or the ED PLUS arm
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Comprehensive Geriatric assessment arm
Arm Type
Experimental
Arm Description
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.
Arm Title
EDPLUS arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Comprehensive Geriatric Assessment arm
Intervention Description
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.,
Intervention Type
Other
Intervention Name(s)
EDPLUS
Intervention Description
EDPLUS involves a 6 week physiotherapy led community based intervention involving 3 home visits and weekly telephone support.
Primary Outcome Measure Information:
Title
Functional Decline
Description
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
Title
Functional Decline
Description
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
Secondary Outcome Measure Information:
Title
Patient Quality of Life
Description
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
Title
Patient satisfaction
Description
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
Title
Rate of ED representation
Description
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
Title
Rate of Hospital readmission
Description
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
Title
Mortality
Description
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
Title
Patient Experience Times
Description
Exact time of admission or discharge form the ED will be collected at 6 weeks post ED index visit
Time Frame
6 weeks
Title
Number of visits to the family doctor or public health nurse
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rose Galvin, PhD
Organizational Affiliation
University of Limerick
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Limerick
City
Limerick
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-021-00954-5
Description
Peer reviewed protocol
URL
https://rdcu.be/cOGBd
Description
shared link

Learn more about this trial

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

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