Therapeutic Conflicts and Multimorbidity

April 7, 2021 updated by: University of Zurich

Therapeutic Conflicts in Hospitalized Patients: Retrospective Analyses of Patients With GI Bleeding or Exacerbated Diabetes and Impact of Multimorbidity.

Clinical practice guidelines do not take into account multimorbidity and various potential therapeutic conflicts. Identifying and quantifying therapeutic conflicts is crucial in multimorbid patients having more than two acute or chronic diseases. Guidance should be available for frequent encountered situations, e.g. gastrointestinal bleeding or exacerbation of diabetes mellitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study investigates multimorbidity in view of the occurrence of two different therapeutic conflicts or dilemma situations, respectively. The first concerns patients with diagnosis of gastrointestinal bleeding and prescription of anticoagulants or/and antiplatelet drugs (e.g., warfarin, clopidogrel and acetylsalicylic acid) as a risk factor for bleeding events. The second concerns patients with diagnosis of exacerbated diabetes mellitus and prescription of corticosteroids as a risk factor for worsening of blood glucose.

Study Type

Observational

Enrollment (Actual)

1101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland
        • University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We investigate in the field of multimorbidity in a tertiary hospital regarding therapeutic conflicts of GI bleeding and diabetes exacerbation.

Description

Inclusion Criteria:

  • Inpatients at the University Hospital Zurich, USZ
  • Male and female patients, aged 18 years or older
  • Fulfilling the criteria for Use Case A or B (i.e. patients with gastrointestinal bleeding and anticoagulants or antiplatelet drugs, Use Case A or patients with diabetes mellitus and/or systemic corticosteroids, Use Case B)

Exclusion Criteria:

  • If potential participants have a statement in the electronic medical record or elsewhere to refuse study participation, this represents exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Multimorbid patients
Other: drug-drug or drug-disease interaction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients with gastrointestinal bleeding and anticoagulants or antiplatelet drugs
Time Frame: 5 years
Do anticoagulants or antiplatelet drugs increase the risk of repeated bleeding in patients with gastrointestinal bleeding?
5 years
Patients with diabetes mellitus and systemic corticosteroids
Time Frame: 5 years
Do systemic corticosteroids increase the risk of exacerbation in patients with diabetes mellitus?
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

University Hospital, Zürich
Center of Competence Multimorbidity, Zurich

Investigators

  • Study Director: Edouard Battegay, Prof. MD, University Hospital Zürich, Department of Internal Medicine
  • Principal Investigator: Klarissa Siebenhüner, MD, University Hospital Zürich, Department of Internal Medicine
  • Study Chair: Patrick Beeler, MD, University Hospital Zürich, Department of Internal Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

April 1, 2021

Study Registration Dates

First Submitted

October 6, 2016

First Submitted That Met QC Criteria

October 7, 2016

First Posted (Estimate)

October 10, 2016

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 7, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-00525

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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