Epidemiology of Polipharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients

Polypharmacy Clinical Trial

— EPIC  

Official title:

Epidemiology of Polipharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03370523
• Other study ID #: MuglaSKUTRH
• Status: Recruiting
• Start date: July 30, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: July 2019
• Source: Mugla Sitki Koçman University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

As the proportion of elderly population increasing over the last years, polypharmacy and drug-drug interactions (DDI) has been a common health care problem. This study will be performed to find out to prevalence of polypharmacy, inappropriate drug use and DDIs in in elderly patients presenting to a outpatient cardiology clinics.

Description:

Objective:

As the proportion of elderly population increasing over the last years, polypharmacy and drug-drug interactions (DDI) has been a common health care problem. However, very limited epidemiologic data are available describing polypharmacy, potentially DDIs, and potentially inappropriate medications and their consequences in elderly Turkish patients. Therefore, this study will be performed to find out to prevalence of polypharmacy, inappropriate drug use and DDIs in elderly patients presenting to a outpatient cardiology clinics.

Methods:

The EPIC (Epidemiology of Polipharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients) study will be the first large-scale, observational, real-world multicenter study to evaluate DDIs ve polypharmacy in elderly cardiac outpatients conducted in Turkey. We will enroll all consecutive patients (aged≥ 65 years) admitted to the outpatient cardiology clinics from January 30, 2018, through June 30, 2018, provided written informed consent. Approximately 5000 patients will be enrolled in this non-interventional study. All the data will be collected at one point in time and current clinical practice will be evaluated.

Results:

Patient demographics, disease characteristics, laboratory test results and medications used willl be collected by self reports and medical records. The severity of comorbid diseases will be recorded and scored according to Charlson comorbidity index (CCI) and patients will be divided into three groups: mild, with CCI scores of 1-2; moderate, with CCI scores of 3-4; and severe, with CCI scores ≥5. Polypharmacy will be defined as being on five or more medications at one time, DDIs will be checked with Lexicomp® and and potentially inappropriate medications will be defined with 2015 update of Beers criteria. Severe drug interactions will be defined with category D or X DIs.

Conclusion:

EPIC will be the first study evaluating polypharmacy, potentially inappropriate medications and DDIs in elderly cardiac outpatients in a real world clinical setting.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: August 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• All consecutive patients with aged = 65 years

Exclusion Criteria:

• Patients under 65 years of age

• Patients who do not want to participate in our study

Related Conditions & MeSH terms

• Drug-drug Interactions
• Polypharmacy

Intervention

Other:
• No intervention is planned in our study
No intervention is planned in our study

Locations

Country	Name	City	State
Turkey	Nizip State Hospital	Gaziantep

Sponsors (1)

Lead Sponsor	Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of polypharmacy	Polypharmacy will be defined as being on five or more medications at one time.	6 months
Primary	Severity of comorbid diseases	The severity of comorbid diseases will be recorded and scored according to Charlson comorbidity index (CCI) and patients will be divided into three groups: mild, with CCI scores of 1-2; moderate, with CCI scores of 3-4; and severe, with CCI scores =5.	6 months
Primary	Drug-drug interactions	DDIs will be checked with Lexicomp®. Severe drug interactions will be defined with category D or X DIs.	6 months
Primary	Prevalence of inappropriate medications	Potentially inappropriate medications will be defined with 2015 update of Beers criteria.	6 months