RISK ANALYSIS AND MANAGEMENT FOR MEDICATION OPTIMIZATION IN THE PREOPERATIVE AND POSTOPERATIVE PERIOD OF CARDIAC SURGICAL PATIENTS

Cardiac Surgery Clinical Trial

Official title:

RISK ANALYSIS AND MANAGEMENT FOR MEDICATION OPTIMIZATION IN THE PREOPERATIVE AND POSTOPERATIVE PERIOD OF CARDIAC SURGICAL PATIENTS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05210335
• Other study ID #: Clinical Pharmacy
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: January 2022
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Optimal perioperative and long-term success in cardiac-surgery require precise management of drug treatment. This study was aimed to determine prevalence, types and associated factors of drug related problems (DRPs) at both preoperative and postoperative stages in patients at cardiac-surgery by using risk analysis method.

Description:

Cardiac surgery becomes a life-saving option in patients once medical treatments become inadequate. In order to achieve optimal perioperative and long- term success in cardiac surgery, drug treatment should be managed precisely. Patients with cardiovascular diseases are at risk for developing drug related problems (DRPs) due to polypharmacy and having received high-alert medications, such as antiarrhythmics or antithrombotic agents. In addition, type of operation (multiple artery bypass or combined valve procedures), existence of chronic atherosclerotic diseases (such as diabetes mellitus, hypertension), length of stay (LOS) at hospital, frailty, changes in medications for unstable cardiac conditions, incomplete or inadequate history for medication at hospital admission, transition between wards by different healthcare teams and transfer of discrepancies throughout entire perioperative period contributes to increased risk of DRPs in patients at cardiac surgery. It has been shown that over one third of patients suffer from DRPs during hospitalization. Clinical pharmacists are in a position to identify and prevent DRPs, therefore can help to provide optimal pharmaceutical treatment by performing medication reconciliation, improving patient compliance, monitoring of laboratory values and conducting patient education for surgical patients.However, there is limited information about prevalence and risk factors of DRPs in patients at cardiac surgery, in particular with perioperative stages. Majority of studies regarding DRPs have been conducted in specific populations such as elderly, pediatrics or in general medicine. Therefore this study was aimed to determine prevalence, types and associated factors of drug related problems (DRPs) at both preoperative and postoperative stages in patients at cardiac-surgery by using risk analysis method.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients are aged 18 years or older
• admitted to the hospital for a planned elective cardiac surgery during the study period were considered eligible.

Exclusion Criteria:

• Patients who refused to participate,
• transferred from different wards
• have urgent surgery planned were excluded

Related Conditions & MeSH terms

• Cardiac Surgery
• Clinical Pharmacy
• Drug Related Problems

Intervention

Other:
• Clinical pharmacist's recommendation to physicians about drug related problems
Clinical pharmacist's recommendation to physicians about drug related problems

Locations

Country	Name	City	State
Turkey	Hacettepe University Faculty of Pharmacy Department of Clinical Pharmacy	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Obtaining drug related problems preoperative and postoperative periods	Obtaining valid drug related problems and their characteristic is the primary outcome as a part of the risk analysis.	6 months (1 November 2019-30 March 2020)
Primary	Building risk analysis model	In line with the valid drug related problems expert panel build the model	3 months (30 March 2020-30 June 2020)
Primary	Obtaining clinical pharmacist affect	Obtaining clinical pharmacist affect as a part of the risk analysis model	6 months (1 August 2020- 30 January 2021)
Secondary	Obtaining clinical pharmacist intervention on other factors	the affect of this model on quality of life, nutritional status, fraility status, hospital mortality rate, length of hospital stay, lenght of intensive care unit stay.	6 months (1 August 2020- 30 January 2021)