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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04629690
Other study ID # SOLAR
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 9, 2020
Est. completion date January 15, 2023

Study information

Verified date June 2023
Source University of Limerick
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

SOLAR is a randomised control trial exploring the role of Comprehensive Geriatric Assessment (CGA) in older adults who screen positive for frailty based on the Identification of Seniors at Risk (ISAR) tool the the Emergency Department and Acute Medical Assessment Unit of a University Teaching Hospital.


Description:

All patients who are over seventy-five will be screened for frailty using the widely used ISAR tool. Those with a score of 2 or above in the ISAR will be randomised. The treatment arm will undergo geriatric medicine team-directed CGA from admission to Emergency Department (ED) or Acute Medical Assessment Unit (AMAU) whereby the non-treatment arm will undergo usual patient care. A dedicated multidisciplinary team of a geriatric medicine trainee, physiotherapist, occupational therapist and medical social worker will carry out the assessment, as well as interventions that arise from that assessment. Primary outcomes will be time from triage to decision to admit or discharge. Secondary Outcomes will be subsequent Emergency Department reattendance, rehospitalisation, functional decline and mortality at 30 days and 180 days. This will be recorded by telephone consultation and electronic records.


Recruitment information / eligibility

Status Completed
Enrollment 229
Est. completion date January 15, 2023
Est. primary completion date May 13, 2021
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility Inclusion Criteria: - Older adults aged 75 years or over - Medically stable as deemed by the treating physician - A score of 2 or above on the ISAR - Present with a medical complaint Exclusion Criteria: - Those under the age of 75 years - A score of less than 2 on the ISAR - Acute myocardial infarction, stroke or non-medical problems e.g. surgical or psychiatric issues - Patients who are medically unstable - If neither the patient nor carer can communicate in English sufficiently to complete consent or baseline assessment - Confirmed or highly suspicious of symptoms for COVID 19.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
SOLAR
The participants will obtain a multidisciplinary assessment regarding their medical conditions, medication review, cognitive assessment, functional assessment, gait and balance assessment by senior clinicians and a management plan will be implemented.

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, 

References & Publications (1)

McCusker J, Bellavance F, Cardin S, Trepanier S, Verdon J, Ardman O. Detection of older people at increased risk of adverse health outcomes after an emergency visit: the ISAR screening tool. J Am Geriatr Soc. 1999 Oct;47(10):1229-37. doi: 10.1111/j.1532-5415.1999.tb05204.x. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Patient Experience Times (PET) PET time recorded as time of arrival at the ED to discharge or admission Exact time of admission or discharge from ED will be collected at 30 days from index visit
Primary Time to admission or discharge and if for admission, time that the bed is booked to go to medical wards. This is the time that the patient is either discharged or identified for admission and bed booked to go to the medical wards Exact time of admission or discharge from ED will be collected at 30 days from index visit
Secondary Rate of ED Representation A record of the patient coming back to the ED within 30 days and/or 6 months 30 days and 6 months
Secondary Mortality A record of the patient having died within 30 days or 6 months 30 days and 6 months
Secondary Rate of Hospital Readmission A record of the patient requiring admission to the hospital within 30 days or 6 months 30 days and 6 months
Secondary Functional Decline As determined by the Barthel Index. Barthel Index is a score from 0-20. A score of 0 is completely dependent, 20 is fully independent. 30 days and 6 months
Secondary Patient Satisfaction- As determined by the Patient Satisfaction Survey III Short Form (PSQ18). This is scored from 18 to 90. 18 being the worst score and 90 being the best score. 30 days
Secondary Patient Quality of Life As determined by the Euro Quality of Life (Qol) EQ5D. Scored from 0 to 100. 0 is worst imaginable health state with 100 being the best imaginable health state 30 days
Secondary Number of visits to family doctor, therapists or public health nurse Determined by self reported visits to family doctor, allied health services or Public Health Nurse. There will be a telephone consultation at 30 days and 6 months where patients will be asked if they have visited a family doctor, therapist or public health nurse in the previous 30 days at the 30 day telephone call, or 6 months at the 6 month phone call. 30 days and 6 months
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