SOLAR- Frailty Screening and Multidisciplinary Assessment of Older Adults in the Emergency Department (SOLAR)

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

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.

Study Overview

• Status: Completed
• Conditions: Frailty
• Intervention / Treatment: Other: SOLAR

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.

• Study Type: Interventional
• Enrollment (Actual): 229
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Limerick, Ireland, v
    • University Hospital Limerick

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Arm; The control group will obtain usual medical care in the Emergency Department and Acute Medical Assessment Unit
Experimental: SOLAR arm; 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.; Other Names: Comprehensive Geriatric Assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Mortality	A record of the patient having died within 30 days or 6 months	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	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.	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.	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	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.	30 days and 6 months

Collaborators and Investigators

• Sponsor: University of Limerick
• Collaborators: University Hospital of Limerick
• Investigators: Principal Investigator: Rose Galvin, phD, University of Limerick

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2020
• Primary Completion (Actual): May 13, 2021
• Study Completion (Actual): January 15, 2023

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 9, 2020
• First Posted (Actual): November 16, 2020

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Emergency Department; Older Adults; Frailty; Comprehensive Geriatric Assessment
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Frailty
• Other Study ID Numbers: SOLAR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No