Clinical trial NCT03796923: 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
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly Syndrome
Transitional Care
Frailty
Readmission
Aging
Elderly
Keywords: Elderly
Hospital at home
Readmission
Transitional care
Frailty
Patient Related Outcome Measures
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2019-01-08
Enrollment: 3340
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Readmission
timeFrame: 30 days
Secondary outcomes:
measure: Mortality
timeFrame: 90 days after admission and 30 days after primary discharge
measure: Length of stay (LOS)
timeFrame: 30 days after primary discharge
Other outcomes:
measure: Physical functional status 30 days after discharge
timeFrame: 30 days after discharge
measure: Duration of readmission
timeFrame: 30 days after discharge
measure: Time at home before readmission
timeFrame: 30 days after discharge
measure: Number of patients discharged directly from the Emergency Department (ED)
timeFrame: 30 days after discharge
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University
Study officials:
affiliation: University of Aarhus
name: Else Marie S Damsgaard, Prof., DMSci
role: STUDY_CHAIR
References:
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.