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Models of Care in the Transition From the Secondary to the Primary Sector Among the Frailest Elderly

Primary Purpose

Frail Elderly Syndrome, Transitional Care, Frailty

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Early follow-up visit after discharge
Comprehensive geriatric assessment (CGA)
Continued geriatric care
Possible follow-up visit from GP
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Frail Elderly Syndrome focused on measuring Elderly, Hospital at home, Readmission, Transitional care, Frailty, Patient Related Outcome Measures

Eligibility Criteria

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

Inclusion Criteria

  • Aged 75 years or older
  • Living within the municipality of Aarhus (except for the control group, see below)
  • MPI-score = 2 (moderate frailty) or MPI score = 3 (severe frailty)

Exclusion Criteria

  • Included in any other kind of follow-up schemes
  • Declared terminally ill or undergoing palliative care at admission
  • Admitted from one specific temporary nursing home with geriatric medical assistance
  • Discharge or transfer to another department, including hospice
  • MPI-score = 1 (low frailty)
  • Discharged to one specific temporary nursing home with geriatric medical assistance
  • The patient does not want a visit after discharge

Sites / Locations

  • Aarhus University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Other

Arm Label

Intervention I

Intervention II

Control

Arm Description

Intervention (I): early follow-up visit from the community nurse within 24 hours after discharge

Intervention (II): early follow-up by the geriatric team within 24 hours after discharge

Usual care: individualized follow-up performed by the GP and municipality services

Outcomes

Primary Outcome Measures

Readmission
Readmission within 30 days after discharge

Secondary Outcome Measures

Mortality
Mortality within 90 days after admission and 30 days after discharge
Length of stay (LOS)
Length of stay during primary admission and total length of stay including following readmissions

Full Information

First Posted
January 2, 2019
Last Updated
April 29, 2021
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT03796923
Brief Title
Models of Care in the Transition From the Secondary to the Primary Sector Among the Frailest Elderly
Official Title
Models of Care in the Transition From the Secondary to the Primary Sector Among the Frailest Elderly +75; a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
September 16, 2020 (Actual)
Study Completion Date
November 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

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

5. Study Description

Brief Summary
In most Western countries the elderly population increases rapidly. In Denmark, the population of elderly aged 75 years or older may amount to nearly 15 % of the entire population in 2050 compared to 9 % today (2017). A large part of the elderly population is at high risk of hospitalization including more admissions and increased morbidity and mortality. The number of hospital beds is declining persistently, calling for shorter lengths of stay (LOS). Increasingly complex treatments now take place outside hospital. Presently, many Danish regional hospitals establish geriatric wards and other geriatric in-hospital and outpatient services to overcome these challenges. The aim of the present PhD-study is to investigate the effects of different models of transitional care among the frailest elderly patients.
Detailed Description
Design Population: The frailest acutely admitted geriatric patients aged +75. Intervention: Early follow-up visits after discharge. Comparison: Usual care follow-up. Outcomes: The primary outcome is readmission within 30 days after discharge. Secondary outcomes are: mortality 30 days after discharge and 90 days after admission, length of stay (LOS), direct discharge from the Emergency Department, time at home before readmission, duration of readmission and physical functional status 30 days after discharge. Methods The first study is conducted as a randomized controlled trial (RCT) using two different degrees of intervention. The second study is a cohort study of an unexposed control group. The third study is sub-group analyses of the RCT data according to frailty status and type of dwelling. A focus group comprised of included patients and relatives will be set to identify additional patient related outcome measures (PROMs) and to participate in an advisory group throughout the remaining project.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frail Elderly Syndrome, Transitional Care, Frailty, Readmission, Aging, Elderly
Keywords
Elderly, Hospital at home, Readmission, Transitional care, Frailty, Patient Related Outcome Measures

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3340 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention I
Arm Type
Active Comparator
Arm Description
Intervention (I): early follow-up visit from the community nurse within 24 hours after discharge
Arm Title
Intervention II
Arm Type
Experimental
Arm Description
Intervention (II): early follow-up by the geriatric team within 24 hours after discharge
Arm Title
Control
Arm Type
Other
Arm Description
Usual care: individualized follow-up performed by the GP and municipality services
Intervention Type
Other
Intervention Name(s)
Early follow-up visit after discharge
Intervention Description
Early follow-up visit and different degrees of specialized care after discharge
Intervention Type
Other
Intervention Name(s)
Comprehensive geriatric assessment (CGA)
Intervention Description
Comprehensive geriatric assessment (CGA) during admission
Intervention Type
Other
Intervention Name(s)
Continued geriatric care
Intervention Description
Continued specialized geriatric care after discharge
Intervention Type
Other
Intervention Name(s)
Possible follow-up visit from GP
Intervention Description
Usual care: follow up visit from GP within one week after discharge
Primary Outcome Measure Information:
Title
Readmission
Description
Readmission within 30 days after discharge
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Mortality
Description
Mortality within 90 days after admission and 30 days after discharge
Time Frame
90 days after admission and 30 days after primary discharge
Title
Length of stay (LOS)
Description
Length of stay during primary admission and total length of stay including following readmissions
Time Frame
30 days after primary discharge
Other Pre-specified Outcome Measures:
Title
Physical functional status 30 days after discharge
Description
Functional Recovery Score ADL and Functional Recovery Score I-ADL: sum-score, range 100-0 (100 is the highest physical functional status score possible, 0 is the lowest)
Time Frame
30 days after discharge
Title
Duration of readmission
Description
Duration of readmission
Time Frame
30 days after discharge
Title
Time at home before readmission
Description
Time at home before readmission
Time Frame
30 days after discharge
Title
Number of patients discharged directly from the Emergency Department (ED)
Description
Patients discharged directly from the ED
Time Frame
30 days after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Aged 75 years or older Living within the municipality of Aarhus (except for the control group, see below) MPI-score = 2 (moderate frailty) or MPI score = 3 (severe frailty) Exclusion Criteria Included in any other kind of follow-up schemes Declared terminally ill or undergoing palliative care at admission Admitted from one specific temporary nursing home with geriatric medical assistance Discharge or transfer to another department, including hospice MPI-score = 1 (low frailty) Discharged to one specific temporary nursing home with geriatric medical assistance The patient does not want a visit after discharge
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Else Marie S Damsgaard, Prof., DMSci
Organizational Affiliation
University of Aarhus
Official's Role
Study Chair
Facility Information:
Facility Name
Aarhus University
City
Aarhus
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34479071
Citation
Hansen TK, Pedersen LH, Shahla S, Damsgaard EM, Bruun JM, Gregersen M. Effects of a new early municipality-based versus a geriatric team-based transitional care intervention on readmission and mortality among frail older patients - a randomised controlled trial. Arch Gerontol Geriatr. 2021 Nov-Dec;97:104511. doi: 10.1016/j.archger.2021.104511. Epub 2021 Aug 26.
Results Reference
derived

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Models of Care in the Transition From the Secondary to the Primary Sector Among the Frailest Elderly

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