PROMTRADUCENCT06597318
Trends of Patient-reported Outcome Measures (PROMs) in Multimorbid Medical Patients Hospitalized for an Acute Illness
An observational study of PROM and PREM, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
currently, PROMs and PREMs are not routinely collected and compared among medical inpatients of Swiss university hospitals, nor is a standard set of PROMs and PREMs available for use in Swiss hospitals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PROM, PREM, Quality of Care
- What is being tested?
- Hospitalization
- How many people
- 1,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2023to 1 Oct 2025
- Phase
- Observational
- 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
Study population: Patients with 2 or more chronic diseases, hospitalized in general internal medicine divisions of all five Swiss university hospitals
Who may be able to join
- eligible for the LUCID registry (CER-VD AO_2023-00029) [Age ≥ 18 years, hospitalized in one of the five participating university hospitals (Geneva, Lausanne, Bern, Zürich, Basel), after 01.01.2014, and admitted to general internal medicine wards
- Multimorbid patients (2 or more chronic diseases, defined as chronic conditions defined by international classification of diseases, 10th revision, codes with an estimated expected duration of at least 6 months or based on a clinical decision.
- Acute illness
- Signature of study specific informed consent
Who cannot join
- Not able to speak French, German or English
- Foreseen length of stay of less than 4 days (estimated by study collaborators)
- Prior inclusion in the TRADUCE study
- Incapacity of discernment, i.e. cognitive impairment which could interfere with the ability to fill in PROMs tools
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Lausanne University Hospital
Lausanne, Canton of Vaud, 1005
Marie Mean, +41213141111
About this study
currently, PROMs and PREMs are not routinely collected and compared among medical inpatients of Swiss university hospitals, nor is a standard set of PROMs and PREMs available for use in Swiss hospitals. The project aims to examine trends in patient-reported outcomes (PROMs), including symptoms, quality of life, and distress, in multimorbid hospitalized patients from admission to 30 days post-discharge. It will also investigate whether PROMs at discharge are linked to the risk of readmission or emergency visits and explore how these outcomes differ in patients who receive low-value care. Additionally, the project will assess the relationship between patient-reported experiences (PREMs) and the provision of low-value care during the hospital stay.
- Conditions
- PROM, PREM, Quality of Care, Internal Medicine
- Being tested
- Hospitalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HospitalizationOther
The investigators collect PROMs amongst up to 1000 patients in general internal medicine divisions of all five Swiss university hospitals
| Study group | Role | What they receive |
|---|---|---|
| multimorbid patients in general internal medicine divisions of all five Swiss university hospitals | Not described Receives: Other: Hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of PROMS with the risk of readmission
The primary objective of the project is to explore trends in PROMs (using the Edmonton Symptom Assessment System (ESAS-r), the EQ-5D-5L index,45 and the National Comprehensive Cancer Network (NCCN) distress thermometer) of multimorbid medical hospitalized patients, from admission until 30-days post-discharge. The patients-reported outcomes will consist of patients-reported symptoms, quality of life and distress
Measured: Day 1, Day 3, at the day of discharge (approximately day 8) and Day 30 after discharge from Hospital
Secondary outcomes (3)
Correlation of PROMs at discharge and risk of hospital readmission or ED visits
assess whether PROMs ((using the Edmonton Symptom Assessment System (ESAS-r), the EQ-5D-5L index,45 and the National Comprehensive Cancer Network (NCCN) distress thermometer) at discharge are associated with the risk of hospital readmission or of emergency department visit within the next 30 days;
Measured: Day 30 after discharge from hospital
Exploration of PROMs in patients who receive low-value care
explore whether PROMs ((using the Edmonton Symptom Assessment System (ESAS-r), the EQ-5D-5L index,45 and the National Comprehensive Cancer Network (NCCN) distress thermometer) trends vary in patients who do or do not receive low value care (LVC);
Measured: Day 1, Day 3, at the day of discharge (approximately day 8) and Day 30 after discharge from Hospital
Explore PREMs
Explore information on Patient Reported Experiences Measures (PREMs) using a qualitative questionnaire during patients' stay at the hospital, and whether there is a correlation between the provision of LVC and qualitative analysis of PREMs
Measured: Since 24 hours after beginning of the hospitalization up to Discharge from Hospital (approximately day 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jul 2023
- Primary completion31 Aug 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PROMStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern, University Hospital, Geneva, University Hospital, Zürich, University Hospital, Basel, Switzerland
- Responsible party
- Principal investigator, Marie Méan, University of Lausanne Hospitals
- Investigators
- Jerome Stirnemann, MD, Principal investigator, University Hospital, GenevaCarole Aubert, MD, Principal investigator, Bern University HospitalFlorence Vallelian Cervetto, MD, Principal investigator, Zürich University HospitalStefano Bassetti, MD, Principal investigator, Basel University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597318
- Sponsor's protocol ID
- 2023-00200
- Other IDs
- 2023
- Acronym
- TRADUCE
- Status last verified
- Sep 2024
- First submitted
- 21 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trends of Patient-reported Outcome Measures (PROMs) in Multimorbid Medical Patients Hospitalized for an Acute Illness
- ClinicalTrials.gov ID
- NCT06597318
- Acronym / sponsor ID
- TRADUCE / 2023-00200
- Conditions
- PROM, PREM, Quality of Care, Internal Medicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern, University Hospital, Geneva, University Hospital, Zürich, University Hospital, Basel, Switzerland
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
currently, PROMs and PREMs are not routinely collected and compared among medical inpatients of Swiss university hospitals, nor is a standard set of PROMs and PREMs available for use in Swiss hospitals. The project aims to examine trends in patient-reported outcomes (PROMs), including symptoms, quality of life, and distress, in multimorbid hospitalized patients from admission to 30 days post-discharge. It will also investigate whether PROMs at discharge are linked to the risk of readmission or emergency visits and explore how these outcomes differ in patients who receive low-value care. Additionally, the project will assess the relationship between patient-reported experiences (PREMs) and the provision of low-value care during the hospital stay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| multimorbid patients in general internal medicine divisions of all five Swiss university hospitals | – | Other: Hospitalization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with 2 or more chronic diseases, hospitalized in general internal medicine divisions of all five Swiss university hospitals
Key inclusion criteria (4 listed)
- eligible for the LUCID registry (CER-VD AO_2023-00029) [Age ≥ 18 years, hospitalized in one of the five participating university hospitals (Geneva, Lausanne, Bern, Zürich, Basel), after 01.01.2014, and admitted to general internal medicine wards
- Multimorbid patients (2 or more chronic diseases, defined as chronic conditions defined by international classification of diseases, 10th revision, codes with an estimated expected duration of at least 6 months or based on a clinical decision.
- Acute illness
- Signature of study specific informed consent
Key exclusion criteria (4 listed)
- Not able to speak French, German or English
- Foreseen length of stay of less than 4 days (estimated by study collaborators)
- Prior inclusion in the TRADUCE study
- Incapacity of discernment, i.e. cognitive impairment which could interfere with the ability to fill in PROMs tools
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 |
|---|---|---|
| HospitalizationThe investigators collect PROMs amongst up to 1000 patients in general internal medicine divisions of all five Swiss university hospitals | Other | multimorbid patients in general internal medicine divisions of all five Swiss university hospitals |
Primary outcome
Correlation of PROMS with the risk of readmission
Time frame: Day 1, Day 3, at the day of discharge (approximately day 8) and Day 30 after discharge from Hospital
The primary objective of the project is to explore trends in PROMs (using the Edmonton Symptom Assessment System (ESAS-r), the EQ-5D-5L index,45 and the National Comprehensive Cancer Network (NCCN) distress thermometer) of multimorbid medical hospitalized patients, from admission until 30-days post-discharge. The patients-reported outcomes will consist of patients-reported symptoms, quality of life and distress
3 secondary outcomes
Correlation of PROMs at discharge and risk of hospital readmission or ED visits
Time frame: Day 30 after discharge from hospital
Exploration of PROMs in patients who receive low-value care
Time frame: Day 1, Day 3, at the day of discharge (approximately day 8) and Day 30 after discharge from Hospital
Explore PREMs
Time frame: Since 24 hours after beginning of the hospitalization up to Discharge from Hospital (approximately day 8)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Jerome Stirnemann, MD principal investigator
University Hospital, Geneva
Carole Aubert, MD principal investigator
Bern University Hospital
Florence Vallelian Cervetto, MD principal investigator
Zürich University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PROM and PREM, run by University of Lausanne Hospitals at 1 site 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Méan, MD (+41 213141111, marie.mean@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of PROMS with the risk of readmission (time frame: Day 1, Day 3, at the day of discharge (approximately day 8) and Day 30 after discharge from Hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.