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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Patient Readmission

Intervention / Treatment
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* Other: TARGET


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TARGET intervention<br>The intervention group will receive a standardized transition care intervention by a trained nurse composed of a pre-discharge component and 2 post-discharge follow-up phone calls 3 days and 14 days after discharge. | Other: TARGET<br>* 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.<br>|
| No Intervention: Control<br>The group control will receive usual care without additional intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day unplanned readmission or death | Number of patients who have a first unplanned readmission or die within 30 days after discharge (Composite endpoint). | 30 days after hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First 30-day unplanned readmission | Number of patients who have a first unplanned readmission (individual components of the primary composite outcome) | 30 days after hospital discharge | 
| 30-day mortality | Number of patients who die (individual components of the primary composite outcome). | 30 days after hospital discharge | 
| Time to first unplanned readmission or death | Number of days between hospital discharge and first unplanned readmission or death. | Within 30 days after hospital discharge | 
| Patient's perspective (satisfaction) on quality of transition of care between hospital and home | Proportion of patients who are responding positively to all 3 items of the Three-Item Care Transition Measure (CTM-3) | 30 days after hospital discharge | 
| Post-discharge health care utilization 1 | Total number of readmission(s) | 30 days after hospital discharge | 
| Post-discharge health care utilization 2 | Total number of days of hospitalizations within 30 days | 30 days after hospital discharge | 
| Post-discharge health care utilization 3 | Number of emergency room visits | 30 days after hospital discharge | 
| Post-discharge health care utilization 4 | Number of primary care provider visits | 30 days after hospital discharge | 
| Main cause of readmission or death | Proportion of most frequent main diagnosis for the readmission | 30 days after hospital discharge | 
| Costs of readmission | Total costs of the rehospitalization in Swiss Francs (CHF) | 30 days after hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prognosis, Randomized Controlled Trial, Patient readmission, Patient transfer, Health care utilization, Multimorbidity, Internal medicine