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

NCT03496896 | Completed

• 1 other identifier: 2018-00084
• Study Type: interventional
• Target: 1,393
• Locations: 1 country
• Sites: 4

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.

Conditions

Patient Readmission

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• First 30-day unplanned readmission

  30 days after hospital discharge

• 30-day mortality

  30 days after hospital discharge

• Time to 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

  30 days after hospital discharge

• Post-discharge health care utilization 1

  30 days after hospital discharge

Study Arms (2)

"TARGET" intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

The group control will receive usual care without additional intervention.

Interventions

TARGET 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.

"TARGET" intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Swiss National Science Foundation: collaborator
• University of Bern: collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (4)

Centre hospitalier Bienne

Biel/Bienne, Canton of Bern, 2502, Switzerland

Location

Hôpital cantonal Fribourg

Fribourg, 1708, Switzerland

Location

Centre hospitalier universitaire vaudois (CHUV)

Lausanne, 1005, Switzerland

Location

Hôpital neuchâtelois

Neuchâtel, 2000, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 37126338 DERIVED

MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Jacques Donzé, MD, MSc

  Bern University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 12, 2018
• Study Start: April 3, 2018
• Primary Completion: February 15, 2020
• Study Completion: February 15, 2020
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

CH (4)