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

Models of Care in the Transition From the Secondary to the Primary Sector Among the Frailest Elderly +75; a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Frail Elderly Syndrome; Frailty; Aging; Elderly; Readmission; Transitional Care
• Intervention / Treatment: Other: Early follow-up visit after discharge; Other: Comprehensive geriatric assessment (CGA); Other: Continued geriatric care; Other: Possible follow-up visit from GP

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.

• Study Type: Interventional
• Enrollment (Actual): 3340
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark
    • Aarhus University

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmission	Readmission within 30 days after discharge	30 days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical functional status 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)	30 days after discharge
Duration of readmission	Duration of readmission	30 days after discharge
Time at home before readmission	Time at home before readmission	30 days after discharge
Number of patients discharged directly from the Emergency Department (ED)	Patients discharged directly from the ED	30 days after discharge

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Study Chair: Else Marie S Damsgaard, Prof., DMSci, University of Aarhus

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): September 16, 2020
• Study Completion (Actual): November 16, 2020

Study Registration Dates

• First Submitted: January 2, 2019
• First Submitted That Met QC Criteria: January 4, 2019
• First Posted (Actual): January 8, 2019

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Elderly; Frailty; Transitional care; Readmission; Hospital at home; Patient Related Outcome Measures
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: MOCATRANFRAELRCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No