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Transition cAre inteRvention tarGeted to High-risk patiEnts To Reduce rEADmission

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03496896
Acronym
TARGET-READ
Enrollment
1393
Registered
2018-04-12
Start date
2018-04-03
Completion date
2020-02-15
Last updated
2023-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Readmission

Keywords

Randomized Controlled Trial, Patient readmission, Patient transfer, Health care utilization, Prognosis, Multimorbidity, Internal medicine

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.

Interventions

OTHERTARGET

The pre-discharge component includes mainly patient information, medication reconciliation, patient education, planning of a first post-discharge primary care physician visit with a timely discharge summary sent to the primary care physician. Two follow-up phone calls are made by a nurse, at D3 and D14, and include the assessment of the general health condition, the verification of the follow-up care plan, a reinforcement of the patient education, and review with the patient of the medication list with assessment of potential adverse drug events.

Sponsors

Swiss National Science Foundation
CollaboratorOTHER
University of Bern
CollaboratorOTHER
Brigham and Women's Hospital
CollaboratorOTHER
Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

Given the nature of the intervention, it will be not possible to blind patients and nurses providing the TARGET intervention. However, treatment allocation in the database will be coded and the study nurses collecting the outcomes or working on data cleaning and the statistician performing the analysis will be blinded to the group allocation.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
30-day unplanned readmission or death30 days after hospital dischargeNumber of patients who have a first unplanned readmission or die within 30 days after discharge (Composite endpoint).

Secondary

MeasureTime frameDescription
30-day mortality30 days after hospital dischargeNumber of patients who die (individual components of the primary composite outcome).
Time to first unplanned readmission or deathWithin 30 days after hospital dischargeNumber of days between hospital discharge and first unplanned readmission or death.
Patient's perspective (satisfaction) on quality of transition of care between hospital and home30 days after hospital dischargeProportion of patients who are responding positively to all 3 items of the Three-Item Care Transition Measure (CTM-3)
Post-discharge health care utilization 130 days after hospital dischargeTotal number of readmission(s)
First 30-day unplanned readmission30 days after hospital dischargeNumber of patients who have a first unplanned readmission (individual components of the primary composite outcome)
Post-discharge health care utilization 330 days after hospital dischargeNumber of emergency room visits
Post-discharge health care utilization 430 days after hospital dischargeNumber of primary care provider visits
Main cause of readmission or death30 days after hospital dischargeProportion of most frequent main diagnosis for the readmission
Costs of readmission30 days after hospital dischargeTotal costs of the rehospitalization in Swiss Francs (CHF)
Post-discharge health care utilization 230 days after hospital dischargeTotal number of days of hospitalizations within 30 days

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026