- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04796701
Effect of a Transitional Care Intervention
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.
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Horsens, Denmark, 8700
- Horsens Regional Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Terminally ill patients
- Patients with cerebrovascular events
- Readmitted to another hospital
- Not able to speak and understand Danish
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Follow Home 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.
|
x
|
NO_INTERVENTION: Control
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Readmission
Time Frame: Readmission will be assessed at 30 days after hospital discharge in both intervention and control group
|
Unplanned all-cause readmission
|
Readmission will be assessed at 30 days after hospital discharge in both intervention and control group
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: Mortality will be assessed at 30 days after hospital discharge in both intervention and control group
|
All-cause mortality
|
Mortality will be assessed at 30 days after hospital discharge in both intervention and control group
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Merete Gregersen, PHD, Aarhus University Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- FH2017-2019
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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