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NCT Number: NCT06597318

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lausanne University Hospital

Lausanne, Canton of Vaud, 1005, Switzerland

Location status: Recruiting

Location contact

Marie Mean

CONTACT

+41213141111

Who can participate

Healthy volunteers accepted: No

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

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

  • 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

Treatment and study plan

Hospitalization

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Correlation of PROMs at discharge and risk of hospital readmission or ED visits

    Time frame: Day 30 after discharge from hospital

    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;

  2. 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 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);

  3. Explore PREMs

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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Marie Méan, MD

CONTACT

[email protected]

+41 213141111

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Collaborators

  • Insel Gruppe AG, University Hospital Bern
  • University Hospital, Basel, Switzerland
  • University Hospital, Geneva
  • University Hospital, Zürich

Registry information

Acronym: TRADUCE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

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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