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Clinical Trials/NCT03496896
NCT03496896
Completed
Not Applicable

Transition cAre inteRvention tarGeted to High-risk patiEnts To Reduce rEADmission (TARGET-READ)

Insel Gruppe AG, University Hospital Bern4 sites in 1 country1,393 target enrollmentApril 3, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patient Readmission
Sponsor
Insel Gruppe AG, University Hospital Bern
Enrollment
1393
Locations
4
Primary Endpoint
30-day unplanned readmission or death
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Hospital rehospitalizations within 30 days are frequent and represent a burden for the patients, but also for the entire health care system. This study evaluates the impact of an intervention targeted to high-risk medical patients in order to reduce their risk of rehospitalization. Half of the patients will receive a set of interventions before and after their hospital discharge, while the other half will receive usual care.

Detailed Description

Background: Hospital readmissions within 30 days are frequent, with rates varying usually between 12 and 20%. Is it therefore recognized as important to improve the quality of the transition of care period in order to avoid as much as possible hospital readmissions. There are however still several gaps in current knowledges. First, most trials to reduce hospital readmission have been performed on specific patient populations such as patients with diabetes or heart failure, and therefore the findings may not be well generalizable to other high-risk population. Second, while some specific interventions have been showed to reduce readmission, these were complex and resources demanding, and no trial targeted these interventions to the patients who are most likely to benefit for better effectiveness, using a widely validated prediction tool, such as the "HOSPITAL" score. Finally, most studies tested unimodal interventions instead of more promising multimodal interventions. Specific aim: the goal of this proposal is to evaluate the effect of a multimodal transitional care intervention prioritized to higher-risk medical patients on the composite of 30-day unplanned readmissions and death. Methods: the investigators will conduct a multicenter randomized controlled trial in medical inpatients discharged home or nursing home, who are identified as having a higher risk for 30-day readmission. Risk of readmission will be predicted using the simplified HOSPITAL score, which includes 6 variables routinely available before hospital discharge and which has been previously validated in more than 200,000 patients across 6 countries in its original version, and in nearly 120,000 patients in its simplified version. Patients will be randomly assigned to the intervention group or usual care group. The primary outcome will be the first 30-day unplanned readmission or all-cause mortality. The primary analysis will be a comparison between two groups according to the intention-to-treat principle.

Registry
clinicaltrials.gov
Start Date
April 3, 2018
End Date
February 15, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adult Patients planned to be discharged home/nursing home from a medical department.
  • Hospital stay of at least 24 hours.
  • Patient at higher risk of 30-day readmission based on the simplified HOSPITAL score.

Exclusion Criteria

  • Previous enrolment in this trial.
  • Patient is not living in the country in the next 30 days.
  • No phone to be reached at.
  • Not speaking the local language.
  • Refusal to participate, or unable to give consent.

Outcomes

Primary Outcomes

30-day unplanned readmission or death

Time Frame: 30 days after hospital discharge

Number of patients who have a first unplanned readmission or die within 30 days after discharge (Composite endpoint).

Secondary Outcomes

  • Post-discharge health care utilization 3(30 days after hospital discharge)
  • 30-day mortality(30 days after hospital discharge)
  • Post-discharge health care utilization 4(30 days after hospital discharge)
  • Time to first unplanned readmission or death(Within 30 days after hospital discharge)
  • Post-discharge health care utilization 1(30 days after hospital discharge)
  • First 30-day unplanned readmission(30 days after hospital discharge)
  • Patient's perspective (satisfaction) on quality of transition of care between hospital and home(30 days after hospital discharge)
  • Post-discharge health care utilization 2(30 days after hospital discharge)
  • Costs of readmission(30 days after hospital discharge)
  • Main cause of readmission or death(30 days after hospital discharge)

Study Sites (4)

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