Clinical trial NCT03496896: Transition cAre inteRvention tarGeted to High-risk patiEnts To Reduce rEADmission
Official title: Transition cAre inteRvention tarGeted to High-risk patiEnts To Reduce rEADmission (TARGET-READ)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Readmission
Keywords: Randomized Controlled Trial
Patient readmission
Patient transfer
Health care utilization
Prognosis
Multimorbidity
Internal medicine
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
name: University of Bern
name: Brigham and Women's Hospital
First posted: 2018-04-12
Enrollment: 1393
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: 30-day unplanned readmission or death
timeFrame: 30 days after hospital discharge
Secondary outcomes:
measure: First 30-day unplanned readmission
timeFrame: 30 days after hospital discharge
measure: 30-day mortality
timeFrame: 30 days after hospital discharge
measure: Time to first unplanned readmission or death
timeFrame: Within 30 days after hospital discharge
measure: Patient's perspective (satisfaction) on quality of transition of care between hospital and home
timeFrame: 30 days after hospital discharge
measure: Post-discharge health care utilization 1
timeFrame: 30 days after hospital discharge
measure: Post-discharge health care utilization 2
timeFrame: 30 days after hospital discharge
measure: Post-discharge health care utilization 3
timeFrame: 30 days after hospital discharge
measure: Post-discharge health care utilization 4
timeFrame: 30 days after hospital discharge
measure: Main cause of readmission or death
timeFrame: 30 days after hospital discharge
measure: Costs of readmission
timeFrame: 30 days after hospital discharge
Other outcomes:
Locations:
city: Bienne
country: Switzerland
facility: Centre hospitalier Bienne
state: Bern
city: Fribourg
country: Switzerland
facility: Hôpital cantonal Fribourg
city: Lausanne
country: Switzerland
facility: Centre hospitalier universitaire vaudois (CHUV)
city: Neuchâtel
country: Switzerland
facility: Hôpital neuchâtelois
Study officials:
affiliation: Bern University Hospital
name: Jacques Donzé, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: