The Role of Clinical Pharmacist in Management of DDIs in CHF Patients
2 other identifiers
interventional
60
1 country
1
Brief Summary
Drug-drug interactions (DDIs) are common in patients with chronic heart failure (CHF) and their incidence increases with the number of drugs that the patients are prescribed for treatment of their condition. Data bases often detect DDIs that are of high clinical relevance. The investigators have performed this study in order to detect clinically significant DDIs and to diminish their occurrence by sending notification about DDIs to attending physician.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 6, 2013
CompletedFirst Posted
Study publicly available on registry
May 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMay 16, 2013
May 1, 2013
8 months
May 6, 2013
May 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the difference in frequency and severity of clinically significant DDIs in control arm and interventional arm between admission and discharge
We will measure the difference in clinically significant DDIs between admission and discharge. The doctors in control group will not receive the advice about DDIs between drugs prescribed to patient, while the doctors in interventional group will. With this will will assess the impact of the advice in the occurence of DDIs between admission and discharge for both groups.
90 days
Study Arms (2)
Advice on DDIs
EXPERIMENTALAttending physician will be randomly assigned to intervention arm care as usual; in the intervention arm, he/she will receive advice about DDIs between medications prescribed to patients on top of general heart failure advice.
General advice
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- Patients admitted with diagnosis of CHF I50.0 - I50.9 and I11.0 - I11.9 (ICD-10)
- patients treated with at least two drugs
You may not qualify if:
- Patients admitted to other conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Clinic Golnik
Golnik, 4204, Slovenia
Related Publications (1)
Roblek T, Deticek A, Leskovar B, Suskovic S, Horvat M, Belic A, Mrhar A, Lainscak M. Clinical-pharmacist intervention reduces clinically relevant drug-drug interactions in patients with heart failure: A randomized, double-blind, controlled trial. Int J Cardiol. 2016 Jan 15;203:647-52. doi: 10.1016/j.ijcard.2015.10.206. Epub 2015 Oct 28.
PMID: 26580349DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Mitja Lainscak, PhD
University Clinic Golnik
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2013
First Posted
May 16, 2013
Study Start
April 1, 2013
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
May 16, 2013
Record last verified: 2013-05