Geriatric DisorderNCT02664948
Early Geriatric Follow-up in Older Acute Medical Patients
A study testing Early geriatric follow-up after discharge in people with Geriatric Disorder, run by University of Aarhus at 1 site in Denmark.
Trial summary
The study is a quasi-randomized controlled trial conducted in a Danish University Hospital including older patients admitted to Emergency Department (ED). 'Early geriatric follow-up' is a multidisciplinary geriatric service provided to older patients who are discharged to their home. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Geriatric Disorder
- What is being tested?
- Early geriatric follow-up after discharge
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,362 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Research Unit, Geriatric Department, Aarhus University Hospital
Aarhus, Central Jutland, 8000
About this study
Official title: Early Geriatric Follow-up After Hospital Discharge in Older Acute Medical Patients - a Quasi Randomized Controlled Trial
The study is a quasi-randomized controlled trial conducted in a Danish University Hospital including older patients admitted to Emergency Department (ED). 'Early geriatric follow-up' is a multidisciplinary geriatric service provided to older patients who are discharged to their home. They receive hospital-visits by a multidisciplinary team no later than 24 hours after discharge (except on sundays). The team is consisting of a physician and a nurse both with geriatric expertise. The physician is responsible for the clinical patient care. The team is available seven days per week/12 hours per day and 24 hour on-call. In the patient's home, the team has the possibility to perform diagnosing and treatment by assessments, medication review, blood tests, subcutaneous fluid therapy, blood transfusions, intravenous antibiotics, rehabilitation and social arrangements. A discharge hand-over supports the caregivers and the GP.
Read the 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.
- Conditions
- Geriatric Disorder
- Being tested
- Early geriatric follow-up after discharge
- Keywords
- early follow-up, geriatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early geriatric follow-up after dischargeProcedure or surgery
Multidisciplinary assessement and intervention by physician, nurse and physiotherapist
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Early geriatric follow-up after discharge from hospital in the patient's home Receives: Procedure: Early geriatric follow-up after discharge |
| Control group | No intervention | Usual care with follow-up home-visits conducted by home care and the GP after discharge, if they consider it as necessary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission (acute)
Number of patients readmitted within 30 days after discharge from hospital
Measured: Outcome measure will be assessed as up to 30 days after discharge.(N=1330)
Secondary outcomes (6)
Length of hospital stay
Number of days from admittance at the ED to discharge from hospital
Measured: 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)
Mortality
Number of patients who died within 90 days after admittance to hospital
Measured: Outcome measure will be assessed as up to 90 days after admittance to hospital (2076)
Patient satisfaction in a sub-group (173 patients)
14-item questionnaire based on qualitative interviews
Measured: Outcome measure will be assessed as up to 30 days after discharge
Health costs per patient
Costs used per patient at the hospital, in home care, by the GP and the pharmacy within 30 days after admittance to ED
Measured: Outcome measure will be assessed from admission as up to 30 days after discharge
Causes of acute readmission
Assessment of avoidable and non-avoidable readmission: The causes of readmissions are assessed by three independent geriatricians through medical chart audits.
Measured: Outcome measure will be assessed up to 30 days after discharge
Physical functional ability
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)
Measured: Outcome measure will be assessed 8 weeks after hospital admission(N=157)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startJun 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric DisorderStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,362 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Else Marie Damsgaard, Professor, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664948
- Sponsor's protocol ID
- G-TOP-2015
- Status last verified
- Dec 2015
- First submitted
- 17 Dec 2015
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Geriatric Follow-up After Hospital Discharge in Older Acute Medical Patients - a Quasi Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02664948
- Acronym / sponsor ID
- G-TOP-2015
- Conditions
- Geriatric Disorder
- Keywords
- early follow-up, geriatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,362 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a quasi-randomized controlled trial conducted in a Danish University Hospital including older patients admitted to Emergency Department (ED). 'Early geriatric follow-up' is a multidisciplinary geriatric service provided to older patients who are discharged to their home. They receive hospital-visits by a multidisciplinary team no later than 24 hours after discharge (except on sundays). The team is consisting of a physician and a nurse both with geriatric expertise. The physician is responsible for the clinical patient care. The team is available seven days per week/12 hours per day and 24 hour on-call. In the patient's home, the team has the possibility to perform diagnosing and treatment by assessments, medication review, blood tests, subcutaneous fluid therapy, blood transfusions, intravenous antibiotics, rehabilitation and social arrangements. A discharge hand-over supports the caregivers and the GP.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Early geriatric follow-up after dischargeEarly geriatric follow-up after discharge from hospital in the patient's home |
| Control group | No intervention | –Usual care with follow-up home-visits conducted by home care and the GP after discharge, if they consider it as necessary |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early geriatric follow-up after dischargeMultidisciplinary assessement and intervention by physician, nurse and physiotherapist | Procedure or surgery | Intervention group |
Primary outcome
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
6 secondary outcomes
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)
Mortality
Time frame: 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
Health costs per patient
Time frame: 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
Physical functional ability
Time frame: Outcome measure will be assessed 8 weeks after hospital admission(N=157)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Else Marie Damsgaard, Professor principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early geriatric follow-up after discharge in people with Geriatric Disorder, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readmission (acute) (time frame: Outcome measure will be assessed as up to 30 days after discharge.(N=1330)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.