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

• ClinicalTrials.gov Identifier: NCT03751319
• Recruitment Status: Completed
• First Posted: November 23, 2018
• Last Update Posted: August 11, 2021
• Sponsor: Helsinki University Central Hospital
• Collaborators: City of Espoo; University of Helsinki
• Information provided by (Responsible Party): Janne Alakare, Helsinki University Central Hospital

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.

Condition or disease	Intervention/treatment	Phase
Frail Elderly Syndrome; Patient Admission; Hospital Readmission; Length of Stay; Fall; Quality of Life	Other: CGA	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 432 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized Controlled Trial
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Geriatric Assessment and Intervention for Older Patients With Frailty in the Emergency Department. Randomized Controlled Trial
• Actual Study Start Date: December 11, 2018
• Actual Primary Completion Date: June 7, 2020
• Actual Study Completion Date: July 2, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

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

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Finland

Helsinki University Hospital, Jorvi ED

Espoo, Uusimaa, Finland, 02740

Sponsors and Collaborators

Helsinki University Central Hospital

City of Espoo

University of Helsinki

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

More Information

Additional Information:

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 

Publications of Results:

Alakare J, Kemp K, Strandberg T, Castrén M, Jakovljević 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.

• Responsible Party: Janne Alakare, Senior physician in Emergency Medicine, Helsinki University Central Hospital
• ClinicalTrials.gov Identifier: NCT03751319
• Other Study ID Numbers: TYH2018304; HUS1171/2018 ( Other Identifier: Helsinki University Hospital )
• First Posted: November 23, 2018
• Last Update Posted: August 11, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Emergencies; Frailty; Disease Attributes; Pathologic Processes