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RecruitingNCT06597318TRADUCEUpdated Sep 19, 2024

Trends of Patient-reported Outcome Measures (PROMs) in Multimorbid Medical Patients Hospitalized for an Acute Illness

An observational study in PROM, PREM and Quality of Care, sponsored by University of Lausanne Hospitals. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by University of Lausanne Hospitals · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • PROM
  • PREM
  • Quality of Care
  • Internal Medicine
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with 2 or more chronic diseases, hospitalized in general internal medicine divisions of all five Swiss university hospitals

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • multimorbid patients in general internal medicine divisions of all five Swiss university hospitals

    Other: Hospitalization

Interventions

  • OtherHospitalization

    The investigators collect PROMs amongst up to 1000 patients in general internal medicine divisions of all five Swiss university hospitals

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: Day 1, Day 3, at the day of discharge (approximately day 8) and Day 30 after discharge from Hospital

Secondary outcomes

  1. 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;

    Time frame: Day 30 after discharge from hospital

  2. 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);

    Time frame: Day 1, Day 3, at the day of discharge (approximately day 8) and Day 30 after discharge from Hospital

  3. 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

    Time frame: Since 24 hours after beginning of the hospitalization up to Discharge from Hospital (approximately day 8)

06

Study locations

1 of 1 sites recruiting
  • Lausanne University Hospital
    Lausanne, Vaud 1005, Switzerland
    • Marie Mean · Contact · +41213141111
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06597318
Lead sponsor
University of Lausanne Hospitals
Collaborators
Insel Gruppe AG, University Hospital Bern, University Hospital, Geneva, University Hospital, Zürich, University Hospital, Basel, Switzerland
Responsible party
Marie Méan (Principal Investigator, Senior Physician, University of Lausanne Hospitals) — Principal investigator
First posted
Sep 19, 2024
Start date
Jul 1, 2023
Primary completion
Aug 31, 2025 (estimated)
Completion
Oct 1, 2025 (estimated)
Last update
Sep 19, 2024

Study contacts

Marie Méan, MD
Contact
marie.mean@chuv.ch
+41 213141111
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
Stefano Bassetti, MD
principal investigator · Basel University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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