AzTrials
AzTrials

FrailtySOLARNCT04629690

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

A study testing SOLAR in people with Frailty, run by University of Limerick at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Frailty
What is being tested?
SOLAR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
229 participants
Where
1 siteIreland
Study dates
9 Nov 2020to 15 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Ireland1 site

  • University Hospital Limerick

    Limerick, v

Other trials in Ireland

About this study

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

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.

Read the 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.

Conditions
Frailty
Being tested
SOLAR
Keywords
Comprehensive Geriatric Assessment, Emergency Department, Older Adults, Frailty
Medical subject headings
Frailty, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SOLAROther

    Also called Comprehensive Geriatric Assessment

    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.

Study groups in NCT04629690
Study groupRoleWhat they receive
Control ArmNo interventionThe control group will obtain usual medical care in the Emergency Department and Acute Medical Assessment Unit
SOLAR armExperimentalThe 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.
Receives: Other: SOLAR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient Experience Times (PET)

    PET time recorded as time of arrival at the ED to discharge or admission

    Measured: Exact time of admission or discharge from ED will be collected at 30 days from index visit

  2. 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

    Measured: Exact time of admission or discharge from ED will be collected at 30 days from index visit

Secondary outcomes (7)

  1. Rate of ED Representation

    A record of the patient coming back to the ED within 30 days and/or 6 months

    Measured: 30 days and 6 months

  2. Mortality

    A record of the patient having died within 30 days or 6 months

    Measured: 30 days and 6 months

  3. Rate of Hospital Readmission

    A record of the patient requiring admission to the hospital within 30 days or 6 months

    Measured: 30 days and 6 months

  4. 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.

    Measured: 30 days and 6 months

  5. 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.

    Measured: 30 days

  6. 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

    Measured: 30 days

  7. 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.

    Measured: 30 days and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2020
  2. Study start9 Nov 2020
  3. Primary completion13 May 2021
  4. Study completion15 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomised control trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
229 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04629690
Sponsor's protocol ID
SOLAR
Acronym
SOLAR
Status last verified
Jun 2023
First submitted
2 Nov 2020
Last updated
13 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual data will be stored on a data repository after the study analysis.

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.

    PubMed 10522957

  • 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.

    PubMed 39541993

  • 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.

    PubMed 34465368

Questions about this trial

What is this clinical trial studying?

A study testing SOLAR in people with Frailty, run by University of Limerick at 1 site in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Experience Times (PET) (time frame: Exact time of admission or discharge from ED will be collected at 30 days from index visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04629690, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in