An interventional study of SOLAR in Frailty, sponsored by University of Limerick. Completed at 1 site in Ireland. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2023-06-13.
Sponsored by University of Limerick · Not applicable, Interventional, and Treatment
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.
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.
1,229 studies on the registry are indexed under Frailty; 433 are open to participants now.
This study's enrollment of 229 is above the median of 80 across 704 interventional studies indexed under Frailty.
Browse Frailty studies →University of Limerick is the lead sponsor of 60 studies on the registry; 9 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The control group will obtain usual medical care in the Emergency Department and Acute Medical Assessment Unit
The SOLAR arm will obtain a comprehensive geriatric assessment which will be provided by a geriatric doctor, physiotherapist, occupational therapist, social worker, pharmacist and specialist nurse.
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.
Also known as: Comprehensive Geriatric Assessment
Patient Experience Times (PET)
PET time recorded as time of arrival at the ED to discharge or admission
Time frame: Exact time of admission or discharge from ED will be collected at 30 days from index visit
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
Time frame: Exact time of admission or discharge from ED will be collected at 30 days from index visit
Rate of ED Representation
A record of the patient coming back to the ED within 30 days and/or 6 months
Time frame: 30 days and 6 months
Mortality
A record of the patient having died within 30 days or 6 months
Time frame: 30 days and 6 months
Rate of Hospital Readmission
A record of the patient requiring admission to the hospital within 30 days or 6 months
Time frame: 30 days and 6 months
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.
Time frame: 30 days and 6 months
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.
Time frame: 30 days
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
Time frame: 30 days
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.
Time frame: 30 days and 6 months
Plan to share: Yes — Individual data will be stored on a data repository after the study analysis.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: The study protocol will be prepared for publication in an open access journal. the study protocol will include the Statistical Analysis Plan and Informed Consent Form. It is likely to be published in Quarter 2 of 2021. The Clinical Study Report will be made publicly available in the form of a peer reviewed publication in late 2021.
Access criteria: Supporting information will be available on peer reviewed publications.
Ran from Nov 2020 to primary completion in May 2021, 6 months.
Of 477 non-industry interventional studies with no phase under Frailty, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 40. This study's 6 months is below that.
Counting every sponsor, half of 484 studies reached it within 21 months; a quarter within 9 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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University of Limerick