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

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 Overview

• Status: Recruiting
• Conditions: PROM; Quality of Care; Internal Medicine; PREM
• Intervention / Treatment: Other: Hospitalization

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Marie Méan, MD; Phone Number: +41 213141111; Email: marie.mean@chuv.ch

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1005
      • Recruiting
      • Lausanne University Hospital
      • Contact: Marie Mean; Phone Number: +41213141111

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
multimorbid patients in general internal medicine divisions of all five Swiss university hospitals	Other: Hospitalization; The investigators collect PROMs amongst up to 1000 patients in general internal medicine divisions of all five Swiss university hospitals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 1, Day 3, at the day of discharge (approximately day 8) and Day 30 after discharge from Hospital

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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;	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);	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	Since 24 hours after beginning of the hospitalization up to Discharge from Hospital (approximately day 8)

Collaborators and Investigators

• Sponsor: University of Lausanne Hospitals
• Collaborators: University Hospital, Geneva; University Hospital, Basel, Switzerland; University Hospital, Zürich; Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Jerome Stirnemann, MD, University Hospital, Geneva; Principal Investigator: Carole Aubert, MD, Bern University Hospital; Principal Investigator: Florence Vallelian Cervetto, MD, Zurich University Hospital; Principal Investigator: Stefano Bassetti, MD, Basel University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: August 21, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 12, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2023-00200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No