Geriatric Assessment and Intervention for Older Patients With Frailty in the Emergency Department

NCT03751319 — Not applicable, Completed, 432 participants, Helsinki University Central Hospital

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Geriatric Assessment and Intervention for Older Patients With Frailty in the Emergency Department. Randomized Controlled Trial

Registry	NCT03751319, acronym GAOPS
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, supportive care
Enrollment	432 (Actual)
Sponsor	Helsinki University Central Hospital (Other); collaborators: City of Espoo, University of Helsinki
Conditions	Frail Elderly Syndrome, Patient Admission, Hospital Readmission, Length of Stay, Fall, Quality of Life
Interventions	CGA (Other)
Dates	start 2018-12-11, primary completion 2020-06-07, completion 2021-07-02, first posted 2018-11-23, last updated 2021-08-11
Locations	1 site in Finland

-Summary

Comprehensive Geriatric Assessment (CGA) is an established approach for better detection of frailty-related problems and includes individualized treatment plan with multi-discipline supportive and treating measures for the older frailty patients. However, there is limited evidence of feasibility and efficacy of the CGA when provided in the emergency department setting.

In the GAOPS-study the efficacy of the CGA in emergency department setting will be studied by randomized controlled study protocol. We aim to study if the CGA provided in the ED is feasible, safe and efficient method when added with standard emergency care for older frail patients.

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+Arms and interventions

Arm	Type	Interventions	Description
Standard Emergency Care + CGA	Active comparator	Other: CGA	Standard Care is provided for the acute condition as usual by the ED personnel. Besides the standard care provided by ED personnel, patients are systemically screened and assessed by physician trained for geriatrics or geriatric emergency medicine. Geriatric multi-discipline treatment plan and recommendations are given if suitable for the case.
Standard Emergency Care	No intervention		Standard Care is provided for the acute condition as usual by the ED personnel.

CGA (Other): Comprehensive Geriatric Assessment

+Outcome measures

Primary outcomes

Cumulated Length of Stay [Day 365]: Cumulated stay (days) in hospital wards (university hospital and community hospital) including all admissions during the follow-up.

Secondary outcomes

Admissions [Day 30, Day 365]: Number of admissions to the hospital wards (university hospital and community hospital) during the follow-up.
Admission rate [Day 0]: Proportion of admitted patients (university hospital or community hospital ward) from the index ED-visits.
Readmissions in the ED [Hour 72, Day 30, Day 365]: Re-visits to the ED after the index-visit.
Living at home [Day 365]: Proportion of the patients living at home.
Quality of Life [Day 0, Day 365]: Change of the quality of life during one year follow-up using the standardized questionnaire EuroQol EQ-5D-5L. Measured value is the index value defined by the EuroQol group.

Other outcomes

Length-of-Stay in the ED [Day 0]: Length-of-Stay (h) of the index-visit in the ED
Length-of-Stay in the ward [Day 365]: Length-of-Stay (d) in the hospital ward of admitted patients from the index-visit in the ED
Mortality [Day 365]: Mortality during the one-year follow-up.
Falls [Day 365]: Number of falls which result in new ED visit during the one-year follow-up

+Eligibility

Sex: All, ages: 75 Years to any

Inclusion Criteria:

* Age of minimum 75 years
* "Clinical Frailty Scale" minimum 4 estimated at the arrival to the ED by nurse

Exclusion Criteria:

* Non-resident of the counties (City of Espoo, Kirkkonummi, Kauniainen) of the hospital district.

+Locations (1)

Facility	City	Country	Status
Helsinki University Hospital, Jorvi ED	Espoo, Uusimaa	Finland

+Publications

Results publication: Alakare J, Kemp K, Strandberg T, Castren M, Jakovljevic D, Tolonen J, Harjola VP. Systematic geriatric assessment for older patients with frailty in the emergency department: a randomised controlled trial. BMC Geriatr. 2021 Jul 2;21(1):408. doi: 10.1186/s12877-021-02351-2. PMID 34215193

+Investigators

Veli-Pekka Harjola, Study director, Department of Emergency Medicine and Services, Helsinki University Hospital
Janne Alakare, MD, Principal investigator, Department of Emergency Medicine and Services, Helsinki University Hospital

My Notes

Public

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