Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03496896
Other study ID # 2018-00084
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 3, 2018
Est. completion date February 15, 2020

Study information

Verified date January 2023
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1393
Est. completion date February 15, 2020
Est. primary completion date February 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Switzerland Centre hospitalier Bienne Bienne Bern
Switzerland Hôpital cantonal Fribourg Fribourg
Switzerland Centre hospitalier universitaire vaudois (CHUV) Lausanne
Switzerland Hôpital neuchâtelois Neuchâtel

Sponsors (4)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne Brigham and Women's Hospital, Swiss National Science Foundation, University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 30-day mortality Number of patients who die (individual components of the primary composite outcome). 30 days after hospital discharge
Secondary 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
Secondary 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
Secondary Post-discharge health care utilization 1 Total number of readmission(s) 30 days after hospital discharge
Secondary Post-discharge health care utilization 2 Total number of days of hospitalizations within 30 days 30 days after hospital discharge
Secondary Post-discharge health care utilization 3 Number of emergency room visits 30 days after hospital discharge
Secondary Post-discharge health care utilization 4 Number of primary care provider visits 30 days after hospital discharge
Secondary Main cause of readmission or death Proportion of most frequent main diagnosis for the readmission 30 days after hospital discharge
Secondary Costs of readmission Total costs of the rehospitalization in Swiss Francs (CHF) 30 days after hospital discharge
See also
  Status Clinical Trial Phase
Completed NCT03066492 - Evaluation of a Hospital Discharge Clinic to Improve Care Coordination and Reduce Rehospitalization in Low Income Adults N/A
Completed NCT03666793 - Comprehensive Management of Drug Prescriptions Throughout the Elderly Person's Hospital Care N/A
Active, not recruiting NCT03733665 - HES and NICOR Data Linkage for Cardiac Failure Population Analysis
Withdrawn NCT05765903 - UM CRMC RecuR Score Pilot N/A
Completed NCT02689076 - Regional Data Exchange to Improve Care for Veterans After Non-VA Hospitalization N/A
Terminated NCT05807750 - Effects Of Income Supplements On 30-Day Readmissions For Vulnerable Older Adults N/A
Not yet recruiting NCT05592847 - A Study of the Effect of a Nurse Navigator Program on High Risk Patients N/A
Recruiting NCT04024735 - Mechanisms of COPD Exacerbation Recurrence
Recruiting NCT03528850 - Stony Brook Telehealth Study N/A
Recruiting NCT03256734 - Does a Complex Care Discharge Planning Initiative Reduce Unplanned Hospital Readmissions? (G78717-Readmits)
Not yet recruiting NCT05980533 - Portable Ultrasound to Predict Heart Failure Readmission Risk N/A
Completed NCT02752997 - Reducing 30-day Readmissions in Patients With Heart Failure Through Pharmacist Discharge Medication Services N/A
Withdrawn NCT02815462 - Impact of Implementing a Real Time Frequent Admitter Risk Score (FAM-FACE-SG) on Readmission Rates N/A
Completed NCT01893931 - Use of a Brief Phone Call After ED Discharge N/A
Completed NCT01292096 - Intervening With and Improving Care for Patients at Risk for Frequent Hospital Admissions Phase 1

External Links