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Effect of a Transitional Care Intervention

Primary Purpose

Frailty

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Follow-Home-intervention
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Frailty focused on measuring readmission, transitional care, discharge, older medical patients

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Horsens Regional Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Follow Home Intervention

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Readmission
Unplanned all-cause readmission

Secondary Outcome Measures

Mortality
All-cause mortality

Full Information

First Posted
February 24, 2021
Last Updated
October 27, 2021
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT04796701
Brief Title
Effect of a Transitional Care Intervention
Official Title
Effect of a Transitional Care Intervention From Hospital to Home on Readmissions Among Older Medical Patients: a Quasi-experimental Study.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
Keywords
readmission, transitional care, discharge, older medical patients

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Non-randomized controlled trial
Masking
None (Open Label)
Masking Description
Intervention group: living in three predefined municipality Control group: living in one predefined municipality
Allocation
Non-Randomized
Enrollment
1266 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Follow Home Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Follow-Home-intervention
Intervention Description
x
Primary Outcome Measure Information:
Title
Readmission
Description
Unplanned all-cause readmission
Time Frame
Readmission will be assessed at 30 days after hospital discharge in both intervention and control group
Secondary Outcome Measure Information:
Title
Mortality
Description
All-cause mortality
Time Frame
Mortality will be assessed at 30 days after hospital discharge in both intervention and control group

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merete Gregersen, PHD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Horsens Regional Hospital
City
Horsens
ZIP/Postal Code
8700
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of a Transitional Care Intervention

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