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Therapeutic Conflicts and Multimorbidity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02928939
Recruitment Status : Active, not recruiting
First Posted : October 10, 2016
Last Update Posted : December 21, 2018
Sponsor:
Collaborators:
University Hospital, Zürich
Center of Competence Multimorbidity, Zurich
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
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.

Condition or disease Intervention/treatment
Gastrointestinal Hemorrhage Diabetes Complications Multimorbidity Other: drug-drug or drug-disease interaction

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.

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Study Type : Observational
Estimated Enrollment : 1600 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Therapeutic Conflicts in Hospitalized Patients: Retrospective Analyses of Patients With GI Bleeding or Exacerbated Diabetes and Impact of Multimorbidity.
Study Start Date : October 2016
Actual Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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?

  2. Patients with diabetes mellitus and systemic corticosteroids [ Time Frame: 5 years ]
    Do systemic corticosteroids increase the risk of exacerbation in patients with diabetes mellitus?



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02928939


Locations
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Switzerland
University Hospital Zurich
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
University Hospital, Zürich
Center of Competence Multimorbidity, Zurich
Investigators
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Study Director: Edouard Battegay, Prof. MD University Hospital Zurich, Department of Internal Medicine
Principal Investigator: Klarissa Siebenhüner, MD University Hospital Zurich, Department of Internal Medicine
Study Chair: Patrick Beeler, MD University Hospital Zurich, Department of Internal Medicine

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02928939    
Other Study ID Numbers: 2016-00525
First Posted: October 10, 2016    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Zurich:
multimorbidity
multiple chronic conditions
drug-drug interactions
drug-disease interactions
polypharmacy
Oral anticoagulants
Steroids
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Diabetes Complications
Hemorrhage
Pathologic Processes
Diabetes Mellitus
Endocrine System Diseases
Gastrointestinal Diseases
Digestive System Diseases