Clinical trial NCT02928939: Therapeutic Conflicts and Multimorbidity
Official title: Therapeutic Conflicts in Hospitalized Patients: Retrospective Analyses of Patients With GI Bleeding or Exacerbated Diabetes and Impact of Multimorbidity.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Hemorrhage
Diabetes Complications
Multimorbidity
Keywords: multimorbidity
multiple chronic conditions
drug-drug interactions
drug-disease interactions
polypharmacy
Oral anticoagulants
Steroids
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University Hospital, Zürich
name: Center of Competence Multimorbidity, Zurich
First posted: 2016-10-10
Enrollment: 1101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Patients with gastrointestinal bleeding and anticoagulants or antiplatelet drugs
timeFrame: 5 years
measure: Patients with diabetes mellitus and systemic corticosteroids
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University Hospital Zurich, Department of Internal Medicine
name: Edouard Battegay, Prof. MD
role: STUDY_DIRECTOR
affiliation: University Hospital Zurich, Department of Internal Medicine
name: Klarissa Siebenhüner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Zurich, Department of Internal Medicine
name: Patrick Beeler, MD
role: STUDY_CHAIR
References: