NCT04629690

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
229

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

November 9, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2021

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

November 2, 2020

Last Update Submit

June 12, 2023

Conditions

Keywords

Comprehensive Geriatric AssessmentEmergency DepartmentOlder AdultsFrailty

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Rate of ED Representation

    30 days and 6 months

  • Mortality

    30 days and 6 months

  • Rate of Hospital Readmission

    30 days and 6 months

  • Functional Decline

    30 days and 6 months

  • Patient Satisfaction-

    30 days

  • +2 more secondary outcomes

Study Arms (2)

Control Arm

NO INTERVENTION

The control group will obtain usual medical care in the Emergency Department and Acute Medical Assessment Unit

SOLAR arm

EXPERIMENTAL

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

Interventions

SOLAROTHER

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
SOLAR arm

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Limerick

Limerick, v, Ireland

Location

Related Publications (3)

  • 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.

    PMID: 10522957BACKGROUND
  • Leahy A, Barry L, Corey G, Whiston A, Purtill H; SOLAR team; Shanahan E, Shchetkovsky D, Ryan D, O'Loughlin M, O'Connor M, Galvin R. Frailty screening with comprehensive geriatrician-led multidisciplinary assessment for older adults during emergency hospital attendance in Ireland (SOLAR): a randomised controlled trial. Lancet Healthy Longev. 2024 Nov;5(11):100642. doi: 10.1016/j.lanhl.2024.100642. Epub 2024 Nov 11.

  • 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.

MeSH Terms

Conditions

FrailtyEmergencies

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth StatusDemographyPopulation CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Rose Galvin, phD

    University of Limerick

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor will be unaware if the participant was in control or intervention arm
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised control trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2020

First Posted

November 16, 2020

Study Start

November 9, 2020

Primary Completion

May 13, 2021

Study Completion

January 15, 2023

Last Updated

June 13, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

Individual data will be stored on a data repository after the study analysis.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
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.

Locations