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

NCT ID: NCT03496896

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1393 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-03
• Study Completion Date: 2020-02-15

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.

Conditions

Patient Readmission

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

"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.

Group Type: EXPERIMENTAL

TARGET

Intervention Type: OTHER

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.

Control

The group control will receive usual care without additional intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss National Science Foundation

OTHER

Sponsor Role: collaborator

University of Bern

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques Donzé, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Bern University Hospital

Locations

Centre hospitalier Bienne

Biel/Bienne, Canton of Bern, Switzerland

Hôpital cantonal Fribourg

Fribourg, , Switzerland

Centre hospitalier universitaire vaudois (CHUV)

Lausanne, , Switzerland

Hôpital neuchâtelois

Neuchâtel, , Switzerland

Countries

Switzerland

References

Donze J, John G, Genne D, Mancinetti M, Gouveia A, Mean M, Butikofer L, Aujesky D, Schnipper J. Effects of a Multimodal Transitional Care Intervention in Patients at High Risk of Readmission: The TARGET-READ Randomized Clinical Trial. JAMA Intern Med. 2023 Jul 1;183(7):658-668. doi: 10.1001/jamainternmed.2023.0791.

Reference Type: DERIVED

PMID: 37126338 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2018-00084

Identifier Type: -

Identifier Source: org_study_id