FrailtyNCT04796701
Effect of a Transitional Care Intervention
A study testing Follow-Home-intervention in people with Frailty, run by University of Aarhus at 1 site in Denmark.
Trial summary
The objective of this study is to evaluate the effect of a transitional care intervention on readmissions among older medical patients. The proportion of older people is rapidly growing. These changes represent a challenge for healthcare systems. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Frailty
- What is being tested?
- Follow-Home-intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,266 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2017to 31 Dec 2019
- 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
- Patients aged ≥75 years
- Living in the municipalities of Odder, Skanderborg, Hedensted or Horsens
- Admitted for ≥48 hours
- Discharged from Medical Ward 1 (MSA1) at Horsens Regional Hospital (HRH)
Who cannot join
- Terminally ill patients
- Patients with cerebrovascular events
- Readmitted to another hospital
- Not able to speak and understand Danish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Transitional Care Intervention From Hospital to Home on Readmissions Among Older Medical Patients: a Quasi-experimental Study.
The objective of this study is to evaluate the effect of a transitional care intervention on readmissions among older medical patients.
The proportion of older people is rapidly growing. These changes represent a challenge for healthcare systems. 20% of all hospital admitted patients ≥ 65 years are readmitted within the first 30 days after discharge. Prior transitional care research has mainly focused on either hospital-based or community-based interventions with no or little intervention elements in both settings. The results show different effects on readmission rates. This calls for new research on trans-sectorial interventions with both pre- and post-discharge elements.
Read the detailed description
Design:
Non-randomized controlled trial.
Participants For eligibility criteria - see elsewhere. Intervention group • Patients living in Odder, Skanderborg or Hedensted municipality
Control group
- Patients living in Horsens municipality
Follow-Home Intervention
The intervention group receives following intervention:
If possible, all included participants are physically followed home by a hospital-based project worker on the day of discharge. During the visit, the focus is on: basic human needs, medication review reconciliation, and a comprehensive geriatric assessment. Problems, challenges and concerns are discussed. Finally, a conference for the following working day is arranged either as a physical visit or a video conference. The patient, relatives, community-based nurse and project worker are invited to participate and health status and challenges are discussed They are recommended to contact the project worker about health and practical issues up to 7 days after discharge where the intervention ends. Subsequently, the responsibility for treatment and care is assigned to the GP and home healthcare provider.
Usual care
Patients in the control group recieves the following usual discharge procedure:
On the day of discharge, the hospital-based nurse digitally sends a summery of the hospital stay and a treatment and care plan to the community-based nurse. If needed, the hospital-based nurse contacts the community-based nurse by phone as a supplement to the plan. Finally, a discharge letter conducted by the hospital-based doctor is digitally sent to the GP.
Method:
Inclusion of participants is consecutive. Inclusion period was between 01/02/17 to 31/12/19. In total, approximately 1200 patients were included .
Data collection Outcome data will be retrieved from CROSS-TRACKS database at 30 days after discharge from index admission.
Analysis
Intervention and Control group will be matched on 3 variables on individual level:
- CCI
- Index admission period: +/- 3-4 weeks
- Sex
All readmissions are included in the analysis (not only first time readmissions). That means that one patient can be included several times.
Logistic regression adjusted for possible confounders will be used when analysing the outcomes. Confounders are chosen through a study specific DAG.
Sub-group analysis will be conducted according to:
- Age
- Sex
- Housing
- Civil status
- Social status
- Length of hospital stay in index admission
- Comorbidity
- Diagnosis
- Ect.
- Conditions
- Frailty
- Being tested
- Follow-Home-intervention
- Keywords
- readmission, transitional care, discharge, older medical patients
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-Home-interventionOther
x
| Study group | Role | What they receive |
|---|---|---|
| Follow Home Intervention | Experimental | If possible, all included participants are physically followed home by a hospital-based project worker on the day of discharge. During the visit, the focus is on: basic human needs, medication review reconciliation, and a comprehensive geriatric assessment. Problems, challenges and concerns are discussed. Finally, a conference for the following working day is arranged either as a physical visit or a video conference. The patient, relatives, community-based nurse and project worker are invited to participate and health status and challenges are discussed They are recommended to contact the project worker about health and practical issues up to 7 days after discharge where the intervention ends. Subsequently, the responsibility for treatment and care is assigned to the GP and home healthcare provider. Receives: Other: Follow-Home-intervention |
| Control | No intervention | On the day of discharge, the hospital-based nurse digitally sends a summary of the hospital stay and a treatment and care plan to the community-based nurse. If needed, the hospital-based nurse contacts the community-based nurse by phone as a supplement to the plan. Finally, a discharge letter conducted by the hospital-based doctor is digitally sent to the GP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission
Unplanned all-cause readmission
Measured: Readmission will be assessed at 30 days after hospital discharge in both intervention and control group
Secondary outcomes (1)
Mortality
All-cause mortality
Measured: Mortality will be assessed at 30 days after hospital discharge in both intervention and control group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start1 Feb 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 1,266 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Merete Gregersen, PHD, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796701
- Sponsor's protocol ID
- FH2017-2019
- Status last verified
- Feb 2021
- First submitted
- 24 Feb 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rasmussen LF, Barat I, Riis AH, Gregersen M, Grode L. Effects of a transitional care intervention on readmission among older medical inpatients: a quasi-experimental study. Eur Geriatr Med. 2023 Feb;14(1):131-144. doi: 10.1007/s41999-022-00730-5. Epub 2022 Dec 23.
PubMed 36564644
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Transitional Care Intervention From Hospital to Home on Readmissions Among Older Medical Patients: a Quasi-experimental Study.
- ClinicalTrials.gov ID
- NCT04796701
- Acronym / sponsor ID
- FH2017-2019
- Conditions
- Frailty
- Keywords
- readmission, transitional care, discharge, older medical patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,266 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 15 Mar 2021 (actual)
- 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 objective of this study is to evaluate the effect of a transitional care intervention on readmissions among older medical patients.
The proportion of older people is rapidly growing. These changes represent a challenge for healthcare systems. 20% of all hospital admitted patients ≥ 65 years are readmitted within the first 30 days after discharge. Prior transitional care research has mainly focused on either hospital-based or community-based interventions with no or little intervention elements in both settings. The results show different effects on readmission rates. This calls for new research on trans-sectorial interventions with both pre- and post-discharge elements.
Detailed description
Design:
Non-randomized controlled trial.
Participants For eligibility criteria - see elsewhere. Intervention group • Patients living in Odder, Skanderborg or Hedensted municipality
Control group
- Patients living in Horsens municipality
Follow-Home Intervention
The intervention group receives following intervention:
If possible, all included participants are physically followed home by a hospital-based project worker on the day of discharge. During the visit, the focus is on: basic human needs, medication review reconciliation, and a comprehensive geriatric assessment. Problems, challenges and concerns are discussed. Finally, a conference for the following working day is arranged either as a physical visit or a video conference. The patient, relatives, community-based nurse and project worker are invited to participate and health status and challenges are discussed They are recommended to contact the project worker about health and practical issues up to 7 days after discharge where the intervention ends. Subsequently, the responsibility for treatment and care is assigned to the GP and home healthcare provider.
Usual care
Patients in the control group recieves the following usual discharge procedure:
On the day of discharge, the hospital-based nurse digitally sends a summery of the hospital stay and a treatment and care plan to the community-based nurse. If needed, the hospital-based nurse contacts the community-based nurse by phone as a supplement to the plan. Finally, a discharge letter conducted by the hospital-based doctor is digitally sent to the GP.
Method:
Inclusion of participants is consecutive. Inclusion period was between 01/02/17 to 31/12/19. In total, approximately 1200 patients were included .
Data collection Outcome data will be retrieved from CROSS-TRACKS database at 30 days after discharge from index admission.
Analysis
Intervention and Control group will be matched on 3 variables on individual level:
- CCI
- Index admission period: +/- 3-4 weeks
- Sex
All readmissions are included in the analysis (not only first time readmissions). That means that one patient can be included several times.
Logistic regression adjusted for possible confounders will be used when analysing the outcomes. Confounders are chosen through a study specific DAG.
Sub-group analysis will be conducted according to:
- Age
- Sex
- Housing
- Civil status
- Social status
- Length of hospital stay in index admission
- Comorbidity
- Diagnosis
- Ect.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Follow Home Intervention | Experimental | Other: Follow-Home-interventionIf possible, all included participants are physically followed home by a hospital-based project worker on the day of discharge. During the visit, the focus is on: basic human needs, medication review reconciliation, and a comprehensive geriatric assessment. Problems, challenges and concerns are discussed. Finally, a conference for the following working day is arranged either as a physical visit or a video conference. The patient, relatives, community-based nurse and project worker are invited to participate and health status and challenges are discussed They are recommended to contact the project worker about health and practical issues up to 7 days after discharge where the intervention ends. Subsequently, the responsibility for treatment and care is assigned to the GP and home healthcare provider. |
| Control | No intervention | –On the day of discharge, the hospital-based nurse digitally sends a summary of the hospital stay and a treatment and care plan to the community-based nurse. If needed, the hospital-based nurse contacts the community-based nurse by phone as a supplement to the plan. Finally, a discharge letter conducted by the hospital-based doctor is digitally sent to the GP |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients aged ≥75 years
- Living in the municipalities of Odder, Skanderborg, Hedensted or Horsens
- Admitted for ≥48 hours
- Discharged from Medical Ward 1 (MSA1) at Horsens Regional Hospital (HRH)
Key exclusion criteria (4 listed)
- Terminally ill patients
- Patients with cerebrovascular events
- Readmitted to another hospital
- Not able to speak and understand Danish
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 |
|---|---|---|
| Follow-Home-interventionx | Other | Follow Home Intervention |
Primary outcome
Readmission
Time frame: Readmission will be assessed at 30 days after hospital discharge in both intervention and control group
Unplanned all-cause readmission
1 secondary outcome
Mortality
Time frame: Mortality will be assessed at 30 days after hospital discharge in both intervention and control group
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 4 Nov 2021.
- Derived from this study: PubMed 36564644Rasmussen LF, Barat I, Riis AH, Gregersen M, Grode L. Effects of a transitional care intervention on readmission among older medical inpatients: a quasi-experimental study. Eur Geriatr Med. 2023 Feb;14(1):131-144. doi: 10.1007/s41999-022-00730-5. Epub 2022 Dec 23.
- 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.
Merete Gregersen, PHD study chair
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 Follow-Home-intervention in people with Frailty, 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 4 inclusion and 4 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 4 Nov 2021. 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 (time frame: Readmission will be assessed at 30 days after hospital discharge in both intervention and control group). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04796701, which also lists 1 linked publication.
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 4 Nov 2021.