Patient ReadmissionTARGET-READNCT03496896
Transition cAre inteRvention tarGeted to High-risk patiEnts To Reduce rEADmission
A study testing TARGET in people with Patient Readmission, run by Insel Gruppe AG, University Hospital Bern at 4 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Readmission
- What is being tested?
- TARGET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,393 participants
- Where
- 4 sitesSwitzerland
- Study dates
- 3 Apr 2018to 15 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Switzerland4 sites
Centre hospitalier Bienne
Biel/Bienne, Canton of Bern, 2502
Hôpital cantonal Fribourg
Fribourg, 1708
Centre hospitalier universitaire vaudois (CHUV)
Lausanne, 1005
Hôpital neuchâtelois
Neuchâtel, 2000
About this study
Official title: Transition cAre inteRvention tarGeted to High-risk patiEnts To Reduce rEADmission (TARGET-READ)
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.
Read the 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
- Being tested
- TARGET
- Keywords
- Randomized Controlled Trial, Patient readmission, Patient transfer, Health care utilization, Prognosis, Multimorbidity, Internal medicine
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TARGETOther
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.
| Study group | Role | What they receive |
|---|---|---|
| "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. Receives: Other: TARGET |
| Control | No intervention | The group control will receive usual care without additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day unplanned readmission or death
Number of patients who have a first unplanned readmission or die within 30 days after discharge (Composite endpoint).
Measured: 30 days after hospital discharge
Secondary outcomes (10)
First 30-day unplanned readmission
Number of patients who have a first unplanned readmission (individual components of the primary composite outcome)
Measured: 30 days after hospital discharge
30-day mortality
Number of patients who die (individual components of the primary composite outcome).
Measured: 30 days after hospital discharge
Time to first unplanned readmission or death
Number of days between hospital discharge and first unplanned readmission or death.
Measured: Within 30 days after hospital discharge
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)
Measured: 30 days after hospital discharge
Post-discharge health care utilization 1
Total number of readmission(s)
Measured: 30 days after hospital discharge
Post-discharge health care utilization 2
Total number of days of hospitalizations within 30 days
Measured: 30 days after hospital discharge
Post-discharge health care utilization 3
Number of emergency room visits
Measured: 30 days after hospital discharge
Post-discharge health care utilization 4
Number of primary care provider visits
Measured: 30 days after hospital discharge
Main cause of readmission or death
Proportion of most frequent main diagnosis for the readmission
Measured: 30 days after hospital discharge
Costs of readmission
Total costs of the rehospitalization in Swiss Francs (CHF)
Measured: 30 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start3 Apr 2018
- Primary completion15 Feb 2020
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient ReadmissionStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,393 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, University of Bern, Brigham and Women's Hospital
- Responsible party
- Sponsor
- Investigators
- Jacques Donzé, MD, MSc, Principal investigator, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496896
- Sponsor's protocol ID
- 2018-00084
- Other IDs
- 2018
- Acronym
- TARGET-READ
- Status last verified
- Jan 2023
- First submitted
- 4 Apr 2018
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37126338
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transition cAre inteRvention tarGeted to High-risk patiEnts To Reduce rEADmission (TARGET-READ)
- ClinicalTrials.gov ID
- NCT03496896
- Acronym / sponsor ID
- TARGET-READ / 2018-00084
- Conditions
- Patient Readmission
- Keywords
- Randomized Controlled Trial, Patient readmission, Patient transfer, Health care utilization, Prognosis, Multimorbidity, Internal medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,393 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, University of Bern, Brigham and Women's Hospital
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "TARGET" intervention | Experimental | Other: TARGETThe 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. |
| Control | No intervention | –The group control will receive usual care without additional intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TARGETThe 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. | Other | "TARGET" intervention |
Primary outcome
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).
10 secondary outcomes
First 30-day unplanned readmission
Time frame: 30 days after hospital discharge
30-day mortality
Time frame: 30 days after hospital discharge
Time to first unplanned readmission or death
Time frame: Within 30 days after hospital discharge
Patient's perspective (satisfaction) on quality of transition of care between hospital and home
Time frame: 30 days after hospital discharge
Post-discharge health care utilization 1
Time frame: 30 days after hospital discharge
Post-discharge health care utilization 2
Time frame: 30 days after hospital discharge
Post-discharge health care utilization 3
Time frame: 30 days after hospital discharge
Post-discharge health care utilization 4
Time frame: 30 days after hospital discharge
Main cause of readmission or death
Time frame: 30 days after hospital discharge
Costs of readmission
Time frame: 30 days after hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Derived from this study: PubMed 37126338Donze 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques Donzé, MD, MSc principal investigator
Bern University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TARGET in people with Patient Readmission, run by Insel Gruppe AG, University Hospital Bern at 4 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day unplanned readmission or death (time frame: 30 days after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03496896, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.