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

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Frail Elderly Syndrome; Fall; Hospital Readmission; Length of Stay; Patient Admission
• Intervention / Treatment: Other: CGA

• Study Type: Interventional
• Enrollment (Actual): 432
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Uusimaa
    • Espoo, Uusimaa, Finland, 02740
      • Helsinki University Hospital, Jorvi ED

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 73 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Emergency Care + 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.	Other: CGA; Comprehensive Geriatric Assessment
No Intervention: Standard Emergency Care; Standard Care is provided for the acute condition as usual by the ED personnel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulated Length of Stay	Cumulated stay (days) in hospital wards (university hospital and community hospital) including all admissions during the follow-up.	Day 365

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Admissions	Number of admissions to the hospital wards (university hospital and community hospital) during the follow-up.	Day 30, Day 365
Admission rate	Proportion of admitted patients (university hospital or community hospital ward) from the index ED-visits.	Day 0
Readmissions in the ED	Re-visits to the ED after the index-visit.	Hour 72, Day 30, Day 365
Living at home	Proportion of the patients living at home.	Day 365
Quality of Life	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.	Day 0, Day 365

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: University of Helsinki; City of Espoo
• Investigators: Study Director: Veli-Pekka Harjola, Department of Emergency Medicine and Services, Helsinki University Hospital; Principal Investigator: Janne Alakare, MD, Department of Emergency Medicine and Services, Helsinki University Hospital

Publications and helpful links

General Publications

• 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.

Helpful Links

• Alakare, J., Kemp, K., Strandberg, T. et al. Systematic geriatric assessment for older patients with frailty in the emergency department: a randomised controlled trial. BMC Geriatr 21, 408 (2021). https://doi.org/10.1186/s12877-021-02351-2

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2018
• Primary Completion (Actual): June 7, 2020
• Study Completion (Actual): July 2, 2021

Study Registration Dates

• First Submitted: November 18, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): August 11, 2021
• Last Update Submitted That Met QC Criteria: August 4, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Frailty
• Other Study ID Numbers: TYH2018304; HUS1171/2018 (Other Identifier: Helsinki University Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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