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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04629690
Recruitment Status : Recruiting
First Posted : November 16, 2020
Last Update Posted : February 9, 2021
Sponsor:
Collaborator:
University Hospital of Limerick
Information provided by (Responsible Party):
University of Limerick

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.

Condition or disease Intervention/treatment Phase
Frailty Other: SOLAR Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised control trial
Masking: Single (Outcomes Assessor)
Masking Description: The outcome assessor will be unaware if the participant was in control or intervention arm
Primary Purpose: Treatment
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
Actual Study Start Date : November 9, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

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 Name: Comprehensive Geriatric Assessment




Primary Outcome Measures :
  1. Patient Experience Times (PET) [ Time Frame: Exact time of admission or discharge from ED will be collected at 30 days from index visit ]
    PET time recorded as time of arrival at the ED to discharge or admission

  2. Time to admission or discharge and if for admission, time that the bed is booked to go to medical wards. [ Time Frame: Exact time of admission or discharge from ED will be collected at 30 days from index visit ]
    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 :
  1. Rate of ED Representation [ Time Frame: 30 days and 6 months ]
    A record of the patient coming back to the ED within 30 days and/or 6 months

  2. Mortality [ Time Frame: 30 days and 6 months ]
    A record of the patient having died within 30 days or 6 months

  3. Rate of Hospital Readmission [ Time Frame: 30 days and 6 months ]
    A record of the patient requiring admission to the hospital within 30 days or 6 months

  4. Functional Decline [ Time Frame: 30 days and 6 months ]
    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.

  5. Patient Satisfaction- [ Time Frame: 30 days ]
    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.

  6. Patient Quality of Life [ Time Frame: 30 days ]
    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

  7. Number of visits to family doctor, therapists or public health nurse [ Time Frame: 30 days and 6 months ]
    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.



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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04629690


Contacts
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Contact: Aoife Leahy, Mb Bch BAO 00 353 61 482100 ext 599 aoife.leahy@ul.ie
Contact: Margaret O'Connor, fRCPI 00 353 61 482100 margaretoconnor9@hse.ie

Locations
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Ireland
University Hospital Limerick Recruiting
Limerick, Ireland, v
Contact: Aoife Leahy, MRCPI    061482100    aoifeleahy@rcsi.ie   
Sponsors and Collaborators
University of Limerick
University Hospital of Limerick
Investigators
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Principal Investigator: Rose Galvin, phD University of Limerick
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Limerick
ClinicalTrials.gov Identifier: NCT04629690    
Other Study ID Numbers: SOLAR
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual data will be stored on a data repository after the study analysis.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Limerick:
Comprehensive Geriatric Assessment
Emergency Department
Older Adults
Frailty
Additional relevant MeSH terms:
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Emergencies
Frailty
Disease Attributes
Pathologic Processes