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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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ClinicalTrials.gov Identifier: NCT03796923
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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.

Condition or disease Intervention/treatment Phase
Frail Elderly Syndrome Transitional Care Frailty Readmission Aging Elderly Other: Early follow-up visit after discharge Other: Comprehensive geriatric assessment (CGA) Other: Continued geriatric care Other: Possible follow-up visit from GP Not Applicable

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, 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 where the two groups in the RCT are compared to an unexposed control group. The third study is sub-group analyses of the RCT data according to frailty status and type of dwelling.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3057 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Models of Care in the Transition From the Secondary to the Primary Sector Among the Frailest Elderly +75; a Randomized Controlled Trial
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Active Comparator: Intervention I
Intervention (I): early follow-up visit from the community nurse within 24 hours after discharge
Other: Early follow-up visit after discharge
Early follow-up visit and different degrees of specialized care after discharge

Other: Comprehensive geriatric assessment (CGA)
Comprehensive geriatric assessment (CGA) during admission

Experimental: Intervention II
Intervention (II): early follow-up by the geriatric team within 24 hours after discharge
Other: Early follow-up visit after discharge
Early follow-up visit and different degrees of specialized care after discharge

Other: Comprehensive geriatric assessment (CGA)
Comprehensive geriatric assessment (CGA) during admission

Other: Continued geriatric care
Continued specialized geriatric care after discharge

Control
Usual care: individualized follow-up performed by the GP and municipality services
Other: Possible follow-up visit from GP
Usual care: follow up visit from GP within one week after discharge




Primary Outcome Measures :
  1. Readmission [ Time Frame: 30 days ]
    Readmission within 30 days after discharge


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 90 days after admission and 30 days after primary discharge ]
    Mortality within 90 days after admission and 30 days after discharge

  2. Length of stay (LOS) [ Time Frame: 30 days after primary discharge ]
    Length of stay during primary admission and total length of stay including following readmissions


Other Outcome Measures:
  1. Physical functional status 30 days after discharge [ Time Frame: 30 days after discharge ]
    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)

  2. Duration of readmission [ Time Frame: 30 days after discharge ]
    Duration of readmission

  3. Time at home before readmission [ Time Frame: 30 days after discharge ]
    Time at home before readmission

  4. Number of patients discharged directly from the Emergency Department (ED) [ Time Frame: 30 days after discharge ]
    Patients discharged directly from the ED



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03796923


Contacts
Contact: Troels Hansen, MD 004530498935 trohas@rm.dk
Contact: Merete Gregersen, PhD meregreg@rm.dk

Locations
Denmark
Aarhus University Recruiting
Aarhus, Denmark
Contact: Helene Nørrelund       hwn@clin.au.dk   
Sub-Investigator: Merete Gregersen         
Principal Investigator: Troels Hansen         
Sponsors and Collaborators
University of Aarhus
Investigators
Study Chair: Else Marie S Damsgaard, Professor, lic. et dr med University of Aarhus
  Study Documents (Full-Text)

Documents provided by University of Aarhus:

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03796923     History of Changes
Other Study ID Numbers: MOCATRANFRAELRCT
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by University of Aarhus:
Elderly
Hospital at home
Readmission
Transitional care
Frailty