- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02664948
Early Geriatric Follow-up in Older Acute Medical Patients
Early Geriatric Follow-up After Hospital Discharge in Older Acute Medical Patients - a Quasi Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is an organizational project, which takes place in a quasi-randomized controlled design.
Every morning at the conference at the Emergency Department, patients are assessed if they are suitable for geriatric assessment and intervention and if so assigned to the Geriatric Team. Then lots are drawn by the Emergency Department's secretary (envelopes in blocks of 10) about two types of organization that is offered the patients that are admitted that day - either: 1) 'early geriatric follow-up' that comprises home visits no later than 24 hours after discharge (=intervention group), or 2) usual care after discharge with 'follow-up visits' by home care and the patient's GP, if they consider it necessary (=control group).
All the assigned patients are offered comprehensive geriatric assessment and intervention by the multidisciplinary team working in the ED consisting of a physician, nurse, and therapist, all with geriatric expertise. The assessment and intervention include evaluation of patient medication, functional ability, and social conditions.
The decision on transfer to home or to the Geriatric ward is influenced by the randomization of the day as 'early geriatric follow-up after discharge' means that more patients, with diseases that would otherwise have required treatment in hospital, can now be treated at home. Intervention patients who are considered to be too ill for treatment at home will be transferred to the Geriatric ward and then afterwards will receive 'early geriatric follow-up after discharge'.
Early follow-up starts with a visit no later than 24 hours after discharge (except for sundays). The first visit is performed by the Geriatric team and after that a tailored follow-up is performed as needed up to 30 days after discharge. The intervention can include services such as medication review, subcutaneous fluid therapy, blood transfusion, intravenous antibiotic treatment, and further examinations. The team can be contacted by phone and by e-mail. If the patient is dependent on assistance from home care, is the intervention performed in close cooperation with those. The home care is in charge of several daily observations with feedback to the team about the patient's illness and disability. In the end of the patient pathway, a discharge summary is sent to the patient's GP.
After discharge, the control group patients receive home-visits as usual by the home care and their GP, if they consider it as necessary. Before discharge, the Geriatric team has contacted the primary care and announced the discharge and sends a discharge letter. The Geriatric team is allowed to phone the patients in the control group after discharge to ensure that everything is in order and to deliver results according to hospital examinations.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Central Denmark Region
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Aarhus, Central Denmark Region, Denmark, 8000
- Research Unit, Geriatric Department, Aarhus University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- older patients aged 75 years or more
- admitted to Emergency Department
- one of following acute illnesses: pneumonia, delirium, dehydration, urinary tract infection, anemia, constipation, and other infection
Exclusion Criteria:
- state of terminal illness
- living outside the municipality of the hospital
- followed by other geriatric specialist teams
- included in the study within the last 30 days
- transferred to another hospital department
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
Early geriatric follow-up after discharge from hospital in the patient's home
|
Multidisciplinary assessement and intervention by physician, nurse and physiotherapist
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No Intervention: Control group
Usual care with follow-up home-visits conducted by home care and the GP after discharge, if they consider it as necessary
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Readmission (acute)
Time Frame: Outcome measure will be assessed as up to 30 days after discharge.(N=1330)
|
Number of patients readmitted within 30 days after discharge from hospital
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Outcome measure will be assessed as up to 30 days after discharge.(N=1330)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of hospital stay
Time Frame: Outcome measure will be calculated from the date of hospital admission and up to date of discharge or date of death during hospital stay whichever came first, assessed up to 6 months (N=1330)
|
Number of days from admittance at the ED to discharge from hospital
|
Outcome measure will be calculated from the date of hospital admission and up to date of discharge or date of death during hospital stay whichever came first, assessed up to 6 months (N=1330)
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Mortality
Time Frame: Outcome measure will be assessed as up to 90 days after admittance to hospital (2076)
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Number of patients who died within 90 days after admittance to hospital
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Outcome measure will be assessed as up to 90 days after admittance to hospital (2076)
|
Patient satisfaction in a sub-group (173 patients)
Time Frame: Outcome measure will be assessed as up to 30 days after discharge
|
14-item questionnaire based on qualitative interviews
|
Outcome measure will be assessed as up to 30 days after discharge
|
Health costs per patient
Time Frame: Outcome measure will be assessed from admission as up to 30 days after discharge
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Costs used per patient at the hospital, in home care, by the GP and the pharmacy within 30 days after admittance to ED
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Outcome measure will be assessed from admission as up to 30 days after discharge
|
Causes of acute readmission
Time Frame: Outcome measure will be assessed up to 30 days after discharge
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Assessment of avoidable and non-avoidable readmission: The causes of readmissions are assessed by three independent geriatricians through medical chart audits.
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Outcome measure will be assessed up to 30 days after discharge
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Physical functional ability
Time Frame: Outcome measure will be assessed 8 weeks after hospital admission(N=157)
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Assessment of Activities of Daily Living measured by Functional Recovery Score (0-100 point scale), and mobility measured by New Mobility Score (0-9 point scale)
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Outcome measure will be assessed 8 weeks after hospital admission(N=157)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Avoidable readmissions
Time Frame: June 2014-November 2015 (N=216)
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Number of avoidable readmissions, based on a manual assessment of medical records performed by two independent reviewers
|
June 2014-November 2015 (N=216)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Else Marie Damsgaard, Professor, Aarhus University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- G-TOP-2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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