Drug Related ProblemsNCT05210335
RISK ANALYSIS AND MANAGEMENT FOR MEDICATION OPTIMIZATION IN THE PREOPERATIVE AND POSTOPERATIVE PERIOD OF CARDIAC SURGICAL PATIENTS
A study testing Clinical pharmacist's recommendation to physicians about drug related problems in people with Drug Related Problems and Clinical Pharmacy, run by Hacettepe University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Related Problems, Clinical Pharmacy, Cardiac Surgery
- What is being tested?
- Clinical pharmacist's recommendation to physicians about drug related problems
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2019to 30 Jun 2021
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are aged 18 years or older
- admitted to the hospital for a planned elective cardiac surgery during the study period were considered eligible.
Who cannot join
- Patients who refused to participate,
- transferred from different wards
- have urgent surgery planned were excluded
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Pharmacy Department of Clinical Pharmacy
Ankara, Altındağ, 06100
About this study
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.
Read the detailed 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.
- Being tested
- Clinical pharmacist's recommendation to physicians about drug related problems
- Keywords
- Drug related problems, Clinical pharmacy, Cardiac surgery, Risk assesment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical pharmacist's recommendation to physicians about drug related problemsOther
Clinical pharmacist's recommendation to physicians about drug related problems
| Study group | Role | What they receive |
|---|---|---|
| Observational part | No intervention | This part covers the list for comprehensive medication use at admission, medication reconciliation and medication review at preoperative surgical ward, postoperative intensive care, postoperative surgical ward and discharge made by clinical pharmacist. The identification and classification of drug related problems was made at each ward according to PCNE classification system. The expert panel (2 surgeon, 2 nurse, 1 pharmacist) scored all the drug related problems as a part of the risk analysis model development. Patients quality of life, nutritional status, cognitive functions and frailty status also recorder at admission, discharge and 1 month after surgery. |
| Interventional part | Experimental | This part covers the list for comprehensive medication use at admission, medication reconciliation and medication review at preoperative surgical ward, postoperative intensive care, postoperative surgical ward and discharge made by clinical pharmacist. Clinical pharmacist made recommendation about drug related problems regarding solutions, record intervention type and problem status differently from observational part. As a component of the risk analysis model the affect of clinical pharmacist was shown clearly. Patients quality of life, nutritional status, cognitive functions and frailty status also recorder at admission, discharge and 1 month after surgery. Receives: Other: Clinical pharmacist's recommendation to physicians about drug related problems |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months (1 November 2019-30 March 2020)
Building risk analysis model
In line with the valid drug related problems expert panel build the model
Measured: 3 months (30 March 2020-30 June 2020)
Obtaining clinical pharmacist affect
Obtaining clinical pharmacist affect as a part of the risk analysis model
Measured: 6 months (1 August 2020- 30 January 2021)
Secondary outcomes (1)
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.
Measured: 6 months (1 August 2020- 30 January 2021)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 Nov 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Related ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Kelleci Cakir, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210335
- Sponsor's protocol ID
- Clinical Pharmacy
- Status last verified
- Jan 2022
- First submitted
- 14 Jan 2022
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This will evaluate upon request