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

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

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.

Study Overview

• Status: Completed
• Conditions: Patient Readmission
• Intervention / Treatment: Other: TARGET

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.

• Study Type: Interventional
• Enrollment (Actual): 1393
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Fribourg, Switzerland, 1708
    • Hopital cantonal Fribourg
  • Lausanne, Switzerland, 1005
    • Centre Hospitalier Universitaire Vaudois (CHUV)
  • Neuchâtel, Switzerland, 2000
    • Hôpital Neuchâtelois
  • Bern
    • Bienne, Bern, Switzerland, 2502
      • Centre hospitalier Bienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "TARGET" intervention; 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; 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.
No Intervention: Control; The group control will receive usual care without additional intervention.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Collaborators: Brigham and Women's Hospital; Swiss National Science Foundation; University of Bern
• Investigators: Principal Investigator: Jacques Donzé, MD, MSc, Bern University Hospital

Publications and helpful links

Helpful Links

• Main study website

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2018
• Primary Completion (Actual): February 15, 2020
• Study Completion (Actual): February 15, 2020

Study Registration Dates

• First Submitted: April 4, 2018
• First Submitted That Met QC Criteria: April 5, 2018
• First Posted (Actual): April 12, 2018

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 24, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Prognosis; Randomized Controlled Trial; Internal medicine; Multimorbidity; Patient readmission; Health care utilization; Patient transfer
• Other Study ID Numbers: 2018-00084

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No