- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05139823
Extended Cross-sectoral Nurse Follow-up After Discharge From a Geriatric Ward - Benefits and Challenges. A Mixed-method Study
Purpose By using both quantitative and qualitative research methods to examine the impact of a coordinated home visit by a geriatric nurse and a community (home care) nurse to vulnerable older patients recently discharged from a geriatric department. The project will address the transition between health care sectors by examining how nursing care information is communicated between sectors, and whether in-home use of digital health solutions can optimize clinical assessments leading to relevant changes in treatment plans and prevention of acute readmissions. User perspectives of both health professionals, patients and their relatives will be applied.
In the quantitative study the primary endpoints are acute readmissions within 30-days and 90-days. The secondary endpoints are 1 year-mortality, numbers of quantitative clinical assessments (e.g., clinical assessment scores, vital signs, POCT) and their associations with clinical decision making, time to readmission, days out of hospital. Financial costs will be assessed.
The qualitative study will provide insight into the challenges and barriers in the transition between hospital and home and opposite as experienced by the patient. Secondly, with a user perspective (i.e. patient, relatives, health professionals) the study will provide in-depth knowledge in the personal care needs of vulnerable patients and how they can be met in a cross-sectoral collaboration between an out-going geriatric nursing team and the home care nursing team. Finally, the important identified complex areas of nursing care during transition will be described and suggested implemented in educational curricula of health professionals.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Eligible participants are patients acutely admitted to G-OUH, residents in Odense Municipality, and discharged to own home with arranged home care for personal care, or discharged to permanent care in a care home.
Exclusion Criteria:
- Excluded from the study are patients discharged to a temporary skilled nursing facility, terminally ill patients with an anticipated short life expectancy, and incapacitated patients, e.g., patients with a diagnosis of dementia or persistent symptoms of cognitive impairment due to delirium during the whole in-hospital stay. Patients with a permanent address in a care home are not excluded by their type of residence unless they are mentally incapacitated.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Controls receive usual care, which is a digital communication to the local home care team including a discharge care plan to the home care system, including information about the discharge diagnoses, and recommendations for particular attention to specific bodily functions and medical treatment regime.
The patient's PCP receives a discharge summary from the treating hospital physician as usual.
|
|
Experimental: Intervention
An appointment for a geriatric follow-up home visit is made with the patient and the municipal home care (community) nurse 2-5 days after discharge and only on weekdays.
Relatives are informed about the visit and are welcome to join with the patient's acceptance.
The local home care team as well as the patient's PCP receives the same digital discharge plan and discharge summary, respectively, as in the control group.
While a follow-up visit is scheduled with the home care nurse, the PCP is invited to join too if available, either in person or by a video link.
Administratively, the patients are treated as geriatric outpatients, with an in-home follow up instead of a visit in the Geriatric outpatient clinic.
|
An appointment for a geriatric follow-up home visit is made with the patient and the municipal home care (community) nurse 2-4 days after discharge and only on weekdays.
Relatives are informed about the visit and are welcome to join with the patient's acceptance.
The local home care team as well as the patient's PCP receives the same digital discharge plan and discharge summary, respectively, as in the control group.
While a follow-up visit is scheduled with the home care nurse, the PCP is invited to join too if available, either in person or by a video link.
Administratively, the patients are treated as geriatric outpatients, with an in-home follow up instead of a visit in the Geriatric outpatient clinic.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute readmissions
Time Frame: 30 days
|
Unplanned readmission within 30 days
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Readmission
Time Frame: 90 day
|
Unplanned readmission within 90 days
|
90 day
|
Mortality
Time Frame: 1 year
|
1-year mortality
|
1 year
|
Time to readmission
Time Frame: 1 year
|
Hazard model of readmission with a duration of one year
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 21/57714
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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