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

• ClinicalTrials.gov Identifier: NCT03496896
• Recruitment Status: Completed
• First Posted: April 12, 2018
• Last Update Posted: January 26, 2023
• Sponsor: Insel Gruppe AG, University Hospital Bern
• Collaborators: Swiss National Science Foundation; University of Bern; Brigham and Women's Hospital
• Information provided by (Responsible Party): Insel Gruppe AG, University Hospital Bern

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Patient Readmission	Other: TARGET	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1393 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Primary Purpose: Health Services Research
• Official Title: Transition cAre inteRvention tarGeted to High-risk patiEnts To Reduce rEADmission (TARGET-READ)
• Actual Study Start Date: April 3, 2018
• Actual Primary Completion Date: February 15, 2020
• Actual Study Completion Date: February 15, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 30-day unplanned readmission or death [ Time Frame: 30 days after hospital discharge ]
   Number of patients who have a first unplanned readmission or die within 30 days after discharge (Composite endpoint).

Secondary Outcome Measures :

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

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Switzerland

Centre hospitalier Bienne

Bienne, Bern, Switzerland, 2502

Hôpital cantonal Fribourg

Fribourg, Switzerland, 1708

Centre hospitalier universitaire vaudois (CHUV)

Lausanne, Switzerland, 1005

Hôpital neuchâtelois

Neuchâtel, Switzerland, 2000

Sponsors and Collaborators

Insel Gruppe AG, University Hospital Bern

Swiss National Science Foundation

University of Bern

Brigham and Women's Hospital

Investigators

• Principal Investigator: Jacques Donzé, MD, MSc; Bern University Hospital

  Study Documents (Full-Text)

Documents provided by Insel Gruppe AG, University Hospital Bern:

Statistical Analysis Plan  [PDF] March 5, 2019

More Information

• Responsible Party: Insel Gruppe AG, University Hospital Bern
• ClinicalTrials.gov Identifier: NCT03496896
• Other Study ID Numbers: 2018-00084
• First Posted: April 12, 2018
• Last Update Posted: January 26, 2023
• Last Verified: January 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Insel Gruppe AG, University Hospital Bern:

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