Back to resultsThe Role of Clinical Pharmacist in Management of DDIs in CHF Patients
Primary Purpose
Chronic Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Advice on DDIs
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Heart Failure focused on measuring chronic heart failure, drug-drug interactions, pharmacist's intervention
Eligibility Criteria
Inclusion Criteria:
- Patients admitted with diagnosis of CHF I50.0 - I50.9 and I11.0 - I11.9 (ICD-10)
- patients treated with at least two drugs
Exclusion Criteria:
- Patients admitted to other conditions
Sites / Locations
- University Clinic GolnikRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Advice on DDIs
General advice
Arm Description
Attending 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01855165
First Posted
May 6, 2013
Last Updated
May 15, 2013
Sponsor
The University Clinic of Pulmonary and Allergic Diseases Golnik
1. Study Identification
Unique Protocol Identification Number
NCT01855165
Brief Title
The Role of Clinical Pharmacist in Management of DDIs in CHF Patients
Official Title
The Role of Clinical Pharmacist's Intervention in Management of Clinically Relevant Drug-drug Interactions in Patients With Chronic Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University Clinic of Pulmonary and Allergic Diseases Golnik
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
chronic heart failure, drug-drug interactions, pharmacist's intervention
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Advice on DDIs
Arm Type
Experimental
Arm Description
Attending 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.
Arm Title
General advice
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Advice on DDIs
Primary Outcome Measure Information:
Title
To assess the difference in frequency and severity of clinically significant DDIs in control arm and interventional arm between admission and discharge
Description
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.
Time Frame
90 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients admitted with diagnosis of CHF I50.0 - I50.9 and I11.0 - I11.9 (ICD-10)
patients treated with at least two drugs
Exclusion Criteria:
Patients admitted to other conditions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mitja Lainscak, PhD
Phone
+38642569141
Email
mitja.lainscak@guest.arnes.si
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitja Lainscak, PhD
Organizational Affiliation
University Clinic Golnik
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinic Golnik
City
Golnik
ZIP/Postal Code
4204
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitja Lainscak, Md, PhD
Phone
+38642569141
Email
mitja.lainscak@guest.arnes.si
First Name & Middle Initial & Last Name & Degree
Mitja Lainscak, MD, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
26580349
Citation
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.
Results Reference
derived
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The Role of Clinical Pharmacist in Management of DDIs in CHF Patients
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