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Completed

NCT Number: NCT03796923

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

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.

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Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University

Aarhus, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early follow-up visit after discharge

Other

Early follow-up visit and different degrees of specialized care after discharge

comprehensive geriatric assessment (CGA)

Other

Comprehensive geriatric assessment (CGA) during admission

Continued geriatric care

Other

Continued specialized geriatric care after discharge

Possible follow-up visit from GP

Other

Usual care: follow up visit from GP within one week after discharge

Primary outcomes

  1. Readmission

    Time frame: 30 days

    Readmission within 30 days after discharge

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 8, 2019
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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