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

NCT06597318 | Recruiting

• 1 other identifier: 2023-00200
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PROM; PREM; Quality of Care; Internal Medicine

Outcome Measures

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

  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

  Day 30 after discharge from hospital

• Exploration of PROMs in patients who receive low-value care

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

• Explore PREMs

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

Study Arms (1)

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

Other: Hospitalization

Interventions

Hospitalization OTHER

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Not able to speak French, German or English
• Foreseen length of stay of less than 4 days (estimated by study collaborators)
• Incapacity of discernment, i.e. cognitive impairment which could interfere with the ability to fill in PROMs tools

Sponsors & Collaborators

• University of Lausanne Hospitals: lead
• Insel Gruppe AG, University Hospital Bern: collaborator
• University Hospital, Geneva: collaborator
• University Hospital, Zürich: collaborator
• University Hospital, Basel, Switzerland: collaborator

Study Sites (1)

Lausanne University Hospital

Lausanne, Canton of Vaud, 1005, Switzerland

RECRUITING

MeSH Terms

Interventions

Hospitalization

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jerome Stirnemann, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

• Carole Aubert, MD

  Bern University Hospital

  PRINCIPAL INVESTIGATOR

• Florence Vallelian Cervetto, MD

  Zürich University Hospital

  PRINCIPAL INVESTIGATOR

• Stefano Bassetti, MD

  Basel University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Méan, MD

CONTACT

+41 213141111; marie.mean@chuv.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Senior Physician

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: September 19, 2024
• Study Start: July 1, 2023
• Primary Completion: August 31, 2025
• Study Completion: October 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)