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NCT Number: NCT03496896

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier Bienne, Biel/Bienne, Canton of Bern, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Brigham and Women's Hospital
  • Swiss National Science Foundation
  • University of Bern

Registry information

Official study title

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

Acronym: TARGET-READ

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 12, 2018
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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