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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04983602
Other study ID # EDPLUS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 13, 2021
Est. completion date June 13, 2022

Study information

Verified date July 2022
Source University of Limerick
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 intervention.


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.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date June 13, 2022
Est. primary completion date June 13, 2022
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Ireland University Hospital Limerick Limerick

Sponsors (2)

Lead Sponsor Collaborator
University of Limerick University Hospital of Limerick

Country where clinical trial is conducted

Ireland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Patient Experience Times Exact time of admission or discharge form the ED will be collected at 6 weeks post ED index visit 6 weeks
Secondary 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
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