SOLAR- Frailty Screening and Multidisciplinary Assessment of Older Adults in the Emergency Department (SOLAR)
Primary Purpose
Frailty
Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
SOLAR
Sponsored by
About this trial
This is an interventional treatment trial for Frailty focused on measuring Comprehensive Geriatric Assessment, Emergency Department, Older Adults, Frailty
Eligibility Criteria
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.
Sites / Locations
- University Hospital Limerick
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Arm
SOLAR arm
Arm Description
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.
Outcomes
Primary Outcome Measures
Patient Experience Times (PET)
PET time recorded as time of arrival at the ED to discharge or admission
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
Secondary Outcome Measures
Rate of ED Representation
A record of the patient coming back to the ED within 30 days and/or 6 months
Mortality
A record of the patient having died within 30 days or 6 months
Rate of Hospital Readmission
A record of the patient requiring admission to the hospital within 30 days or 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.
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.
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
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.
Full Information
NCT ID
NCT04629690
First Posted
November 2, 2020
Last Updated
June 12, 2023
Sponsor
University of Limerick
Collaborators
University Hospital of Limerick
1. Study Identification
Unique Protocol Identification Number
NCT04629690
Brief Title
SOLAR- Frailty Screening and Multidisciplinary Assessment of Older Adults in the Emergency Department
Acronym
SOLAR
Official Title
The Impact of Frailty Screening of Older Adults With muLtidisciplinary Assessment of Those At Risk During Emergency Hospital Attendance on the Quality, Safety and Cost-effectiveness of Care (SOLAR): a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 9, 2020 (Actual)
Primary Completion Date
May 13, 2021 (Actual)
Study Completion Date
January 15, 2023 (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
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
Keywords
Comprehensive Geriatric Assessment, Emergency Department, Older Adults, Frailty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised control trial
Masking
Outcomes Assessor
Masking Description
The outcome assessor will be unaware if the participant was in control or intervention arm
Allocation
Randomized
Enrollment
229 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
The control group will obtain usual medical care in the Emergency Department and Acute Medical Assessment Unit
Arm Title
SOLAR arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
SOLAR
Other Intervention Name(s)
Comprehensive Geriatric Assessment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Experience Times (PET)
Description
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
Title
Time to admission or discharge and if for admission, time that the bed is booked to go to medical wards.
Description
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
Secondary Outcome Measure Information:
Title
Rate of ED Representation
Description
A record of the patient coming back to the ED within 30 days and/or 6 months
Time Frame
30 days and 6 months
Title
Mortality
Description
A record of the patient having died within 30 days or 6 months
Time Frame
30 days and 6 months
Title
Rate of Hospital Readmission
Description
A record of the patient requiring admission to the hospital within 30 days or 6 months
Time Frame
30 days and 6 months
Title
Functional Decline
Description
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
Title
Patient Satisfaction-
Description
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
Title
Patient Quality of Life
Description
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
Title
Number of visits to family doctor, therapists or public health nurse
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
ZIP/Postal Code
v
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 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.
IPD Sharing Access Criteria
Supporting information will be available on peer reviewed publications.
Citations:
PubMed Identifier
10522957
Citation
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.
Results Reference
background
PubMed Identifier
34465368
Citation
Leahy A, McNamara R, Reddin C, Corey G, Carroll I; SOLAR team; O'Neill A, Flannery D, Devlin C, Barry L, MacCarthy B, Cummins N, Shanahan E, Shchetkovsky D, Ryan D, O'Connor M, Galvin R. The impact of frailty Screening of Older adults with muLtidisciplinary assessment of those At Risk during emergency hospital attendance on the quality, safety and cost-effectiveness of care (SOLAR): a randomised controlled trial. Trials. 2021 Aug 31;22(1):581. doi: 10.1186/s13063-021-05525-w.
Results Reference
derived
Learn more about this trial
SOLAR- Frailty Screening and Multidisciplinary Assessment of Older Adults in the Emergency Department
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