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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03796923
• Other study ID #: MOCATRANFRAELRCT
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: November 16, 2020

Study information

• Verified date: April 2021
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3340
• Est. completion date: November 16, 2020
• Est. primary completion date: September 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Elderly
• Frail Elderly Syndrome
• Frailty
• Readmission
• Transitional Care

Intervention

Other:
• Early follow-up visit after discharge
Early follow-up visit and different degrees of specialized care after discharge
• Comprehensive geriatric assessment (CGA)
Comprehensive geriatric assessment (CGA) during admission
• Continued geriatric care
Continued specialized geriatric care after discharge
• Possible follow-up visit from GP
Usual care: follow up visit from GP within one week after discharge

Locations

Country	Name	City	State
Denmark	Aarhus University	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Duration of readmission	Duration of readmission	30 days after discharge
Other	Time at home before readmission	Time at home before readmission	30 days after discharge
Other	Number of patients discharged directly from the Emergency Department (ED)	Patients discharged directly from the ED	30 days after discharge
Primary	Readmission	Readmission within 30 days after discharge	30 days
Secondary	Mortality	Mortality within 90 days after admission and 30 days after discharge	90 days after admission and 30 days after primary discharge
Secondary	Length of stay (LOS)	Length of stay during primary admission and total length of stay including following readmissions	30 days after primary discharge