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

Primary Purpose

Frail Elderly Syndrome, Patient Admission, Hospital Readmission

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
CGA
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Frail Elderly Syndrome

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Helsinki University Hospital, Jorvi ED

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Standard Emergency Care + CGA

Standard Emergency Care

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Admissions
Number of admissions to the hospital wards (university hospital and community hospital) during the follow-up.
Admission rate
Proportion of admitted patients (university hospital or community hospital ward) from the index ED-visits.
Readmissions in the ED
Re-visits to the ED after the index-visit.
Living at home
Proportion of the patients living at home.
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.

Full Information

First Posted
November 18, 2018
Last Updated
August 4, 2021
Sponsor
Helsinki University Central Hospital
Collaborators
City of Espoo, University of Helsinki
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1. Study Identification

Unique Protocol Identification Number
NCT03751319
Brief Title
Geriatric Assessment and Intervention for Older Patients With Frailty in the Emergency Department
Acronym
GAOPS
Official Title
Geriatric Assessment and Intervention for Older Patients With Frailty in the Emergency Department. Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 11, 2018 (Actual)
Primary Completion Date
June 7, 2020 (Actual)
Study Completion Date
July 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
Collaborators
City of Espoo, University of Helsinki

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frail Elderly Syndrome, Patient Admission, Hospital Readmission, Length of Stay, Fall, Quality of Life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
432 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Emergency Care + CGA
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard Emergency Care
Arm Type
No Intervention
Arm Description
Standard Care is provided for the acute condition as usual by the ED personnel.
Intervention Type
Other
Intervention Name(s)
CGA
Intervention Description
Comprehensive Geriatric Assessment
Primary Outcome Measure Information:
Title
Cumulated Length of Stay
Description
Cumulated stay (days) in hospital wards (university hospital and community hospital) including all admissions during the follow-up.
Time Frame
Day 365
Secondary Outcome Measure Information:
Title
Admissions
Description
Number of admissions to the hospital wards (university hospital and community hospital) during the follow-up.
Time Frame
Day 30, Day 365
Title
Admission rate
Description
Proportion of admitted patients (university hospital or community hospital ward) from the index ED-visits.
Time Frame
Day 0
Title
Readmissions in the ED
Description
Re-visits to the ED after the index-visit.
Time Frame
Hour 72, Day 30, Day 365
Title
Living at home
Description
Proportion of the patients living at home.
Time Frame
Day 365
Title
Quality of Life
Description
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.
Time Frame
Day 0, Day 365
Other Pre-specified Outcome Measures:
Title
Length-of-Stay in the ED
Description
Length-of-Stay (h) of the index-visit in the ED
Time Frame
Day 0
Title
Length-of-Stay in the ward
Description
Length-of-Stay (d) in the hospital ward of admitted patients from the index-visit in the ED
Time Frame
Day 365
Title
Mortality
Description
Mortality during the one-year follow-up.
Time Frame
Day 365
Title
Falls
Description
Number of falls which result in new ED visit during the one-year follow-up
Time Frame
Day 365

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veli-Pekka Harjola
Organizational Affiliation
Department of Emergency Medicine and Services, Helsinki University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Janne Alakare, MD
Organizational Affiliation
Department of Emergency Medicine and Services, Helsinki University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Hospital, Jorvi ED
City
Espoo
State/Province
Uusimaa
ZIP/Postal Code
02740
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34215193
Citation
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.
Results Reference
result
Links:
URL
https://bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-021-02351-2
Description
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

Learn more about this trial

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

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