NCT03751319

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
432

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

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 18, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 23, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

December 11, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2021

Completed
Last Updated

August 11, 2021

Status Verified

August 1, 2021

Enrollment Period

1.5 years

First QC Date

November 18, 2018

Last Update Submit

August 4, 2021

Conditions

Frail Elderly SyndromePatient AdmissionHospital ReadmissionLength of StayFallQuality of Life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Admissions

    Day 30, Day 365

  • Admission rate

    Day 0

  • Readmissions in the ED

    Hour 72, Day 30, Day 365

  • Living at home

    Day 365

  • Quality of Life

    Day 0, Day 365

Other Outcomes (4)

  • Length-of-Stay in the ED

    Day 0

  • Length-of-Stay in the ward

    Day 365

  • Mortality

    Day 365

  • +1 more other outcomes

Study Arms (2)

Standard Emergency Care + CGA

ACTIVE COMPARATOR

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

Standard Emergency Care

NO INTERVENTION

Standard Care is provided for the acute condition as usual by the ED personnel.

Interventions

CGAOTHER

Comprehensive Geriatric Assessment

Standard Emergency Care + CGA

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Hospital, Jorvi ED

Espoo, Uusimaa, 02740, Finland

Location

Related Publications (1)

  • 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: 34215193RESULT

Related Links

Study Officials

  • Veli-Pekka Harjola

    Department of Emergency Medicine and Services, Helsinki University Hospital

    STUDY DIRECTOR

  • Janne Alakare, MD

    Department of Emergency Medicine and Services, Helsinki University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior physician in Emergency Medicine

Study Record Dates

First Submitted

November 18, 2018

First Posted

November 23, 2018

Study Start

December 11, 2018

Primary Completion

June 7, 2020

Study Completion

July 2, 2021

Last Updated

August 11, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)