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

Patient Readmission Clinical Trial

— TARGET-READ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03496896
• Other study ID #: 2018-00084
• Status: Completed
• Phase: N/A
• Start date: April 3, 2018
• Est. completion date: February 15, 2020

Study information

• Verified date: January 2023
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1393
• Est. completion date: February 15, 2020
• Est. primary completion date: February 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Patient Readmission

Intervention

Other:
• TARGET
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.

Locations

Country	Name	City	State
Switzerland	Centre hospitalier Bienne	Bienne	Bern
Switzerland	Hôpital cantonal Fribourg	Fribourg
Switzerland	Centre hospitalier universitaire vaudois (CHUV)	Lausanne
Switzerland	Hôpital neuchâtelois	Neuchâtel

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Brigham and Women's Hospital, Swiss National Science Foundation, University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	30-day mortality	Number of patients who die (individual components of the primary composite outcome).	30 days after hospital discharge
Secondary	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
Secondary	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
Secondary	Post-discharge health care utilization 1	Total number of readmission(s)	30 days after hospital discharge
Secondary	Post-discharge health care utilization 2	Total number of days of hospitalizations within 30 days	30 days after hospital discharge
Secondary	Post-discharge health care utilization 3	Number of emergency room visits	30 days after hospital discharge
Secondary	Post-discharge health care utilization 4	Number of primary care provider visits	30 days after hospital discharge
Secondary	Main cause of readmission or death	Proportion of most frequent main diagnosis for the readmission	30 days after hospital discharge
Secondary	Costs of readmission	Total costs of the rehospitalization in Swiss Francs (CHF)	30 days after hospital discharge

External Links

•   Main study website