Cardiovascular DiseasesNCT06193473
Evaluation Of Clinical Pharmacy Services in Patients Receiving Antithrombotic Treatment
A study testing Intervention Group: Group to which the clinical pharmacist makes recommendations in people with Cardiovascular Diseases and Drug Use, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Clinical pharmacy services aim to enhance patient outcomes and reduce the risk of potential drug-related harm by offering patient-centred pharmaceutical care. In the hospital setting, clinical pharmacists collaborate with physicians as part of a multidisciplinary team to identify and prevent DRPs (Drug-related… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Drug Use
- What is being tested?
- Intervention Group: Group to which the clinical pharmacist makes recommendations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2021to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Being 18 years and older.
- Receiving antithrombotic treatment.
- Having complete biochemical and complete blood count values collected at least twice, with two-day medication information fully entered into the hospital system.
- Patients who could be evaluated by the clinical pharmacist for at least 24 hours within the intervention group.
Who cannot join
- Being under 18 years old.
- Not using antithrombotic medication.
- Patients whose biochemical and complete blood count values were not collected twice and whose two-day medication information was not fully recorded in the hospital system.
- Patients in the intervention group whom the clinical pharmacist did not see for at least 24 hours (weekend hospital admission followed by Monday morning discharge, Friday admission with weekend discharge, etc.) were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakıf Üniversitesi
Istanbul, Fatih, 34096
About this study
Clinical pharmacy services aim to enhance patient outcomes and reduce the risk of potential drug-related harm by offering patient-centred pharmaceutical care. In the hospital setting, clinical pharmacists collaborate with physicians as part of a multidisciplinary team to identify and prevent DRPs (Drug-related problems). Clinical pharmacist interventions encompass 'any action initiated by a pharmacist that directly results in patient management or a modification in medication.' The favourable clinical and economic impacts of interventions have been well-established for decades. Clinical pharmacists have played an important role in ensuring the effective and correct use of medicines in many settings.
This study aims to investigate the clinical pharmacy services provided by clinical pharmacists to patients receiving antithrombotic therapy. For this study, patients were divided into two groups: a control group and an intervention group. A comprehensive medication review will be conducted by the clinical pharmacist for both the control and intervention groups. Drug-related problems such as drug selection, dose errors, possible drug-drug interactions, and inappropriate drug use, will be identified. In the control group, no interventions will be made by the clinical pharmacist. In the intervention group, solution recommendations for identified and clinically significant issues will be presented to the physician, and the provided services will be documented. Furthermore, the groups will be evaluated for whether there are any hospital readmissions within 1 and 3 months following discharge for the patients.
Read the detailed description
Patients with cardiovascular disease are at significant risk for adverse drug events and medication errors. Moreover, the rate of use of high-risk drugs such as antithrombotic drugs is higher in these patients. In the literature, antithrombotics have been shown as one of the main causes of adverse drug events and drug-related hospitalizations. Therefore, follow-up of patients treated with antithrombotics is very important. Guideline-based therapy significantly reduces the risk of all-cause and cardiovascular (CV) death. Multidisciplinary antithrombotic management can play an important role in increasing prescribing physicians' adherence to guidelines. Effective interventions such as medication review, establishment of treatment protocols, education, and medication reconciliation at hospitalization and discharge can help increase adherence to the guideline. In patients receiving antithrombotic therapy, individual evaluation of drug therapy suitability, formulation of a drug treatment plan, dose adjustment, drug monitoring, detection and prevention of clinically important drug-drug interactions, and antithrombotic transition protocols should be considered. Such interventions must appropriately balance each individual's risk of thromboss and bleeding.
Pharmacists are recognized as leading healthcare professionals in detecting, resolving, and preventing DRPs. Assessments of the quality and value of pharmacist interventions remain crucial for the development of new pharmaceutical care services and for enhancing our understanding of the frequency and variety of DRPs observed in various clinical settings. The literature has demonstrated the impact of Clinical Pharmacy Services on cardiovascular patients. Collaborating with a clinical pharmacist during inpatient treatment has been shown to improve medication adherence, reduce adverse drug reactions, and minimize medication errors post-discharge. The benefits of these pharmacist-led services in reducing hospitalization and healthcare costs were emphasized. Clinical pharmacy services have contributed to an enhancement in healthcare quality without compromising patient well-being. Pharmacists can take on the responsibility of antithrombotic management, ensuring that patients receive the right medication, in the correct dosage, and for the appropriate duration from the initial consultation to outpatient follow-up. Increasing the continuity of pharmaceutical care will enhance patient outcomes and reduce costs.
In this study, two groups were established as control group and intervention group. In the control group, no interventions will be made by the Clinical Pharmacist. Within the intervention group, patient characteristics such as the length of hospital stay, reason for hospitalization, underlying conditions, and the appropriateness of prescribed medications were evaluated for the patients who received antithrombotic treatment and met the inclusion criteria. Through medication reviews, evaluations were made to identify drug-related problems and provide solutions to these problems. The clinical pharmacist provided recommendations to the physicians regarding significant clinically important problems. Additionally, follow-up was performed to determine whether the patients had a re-admission within 3 months.
- Conditions
- Cardiovascular Diseases, Drug Use
- Being tested
- Intervention Group: Group to which the clinical pharmacist makes recommendations
- Keywords
- clinical pharmacist, antithrombotic drugs, drug-related problems, cardiovascular diseases
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Group: Group to which the clinical pharmacist makes recommendationsBehavioural
The drugs administered to patients within 24-48 hours after hospitalization were recorded. A detailed medication review will be conducted by the clinical pharmacist during the participants' hospitalization.As a result of a comprehensive evaluation, recommendations were made to doctors regarding drug-related problems and were recorded.
| Study group | Role | What they receive |
|---|---|---|
| Control Group: Group in which only observation is made by the clinical pharmacist | No intervention | For patients in this group, no intervention (i.e. recommendation) will be made to physicians by the clinical pharmacist. Within the intervention group, patient characteristics such as the length of hospital stay, reason for hospitalization, underlying conditions, and the appropriateness of prescribed medications were evaluated for the patients who received antithrombotic treatment and met the inclusion criteria. The participant will take standard treatment. Evaluations will be recorded. Follow-up was performed to determine whether the patients had a re-admission within 3 months. |
| Intervention Group: Group to which the clinical pharmacist makes recommendations | Experimental | For patients in this group, intervention (i.e. recommendation) will be made to physicians by the clinical pharmacist. Within the intervention group, patient characteristics such as the length of hospital stay, reason for hospitalization, underlying conditions, and the appropriateness of prescribed medications were evaluated for the patients who received antithrombotic treatment and met the inclusion criteria. Through medication reviews, evaluations were made to identify drug-related problems and provide solutions to these problems. The clinical pharmacist provided recommendations to the physicians regarding significant clinically important problems. Additionally, follow-up was performed to determine whether the patients had a re-admission within 3 months. Receives: Behavioral: Intervention Group: Group to which the clinical pharmacist makes recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance rate of suggested intervention (number)
Acceptance rate of suggested intervention. Medication-related problems and recommendations are classified according to PCNE (Pharmaceutical Care Network Europe) version 9.1. It was recorded how many suggestions were made in the intervention group and how many of these suggestions were accepted.
Measured: From the date of randomization until there are 200 patient participants in each group. Average 1 year.
Length of hospital stay (days)
Length of hospital stay
Measured: From date of randomization until the date of discharge from the hospital, assessed up to 1 year.
Within three months readmission (number of patients re-admitted to hospital)
In order to determine which group of patients has the highest number of hospital re-admissions and to evaluate whether there is a significant difference between the groups.
Measured: Whether patients were readmitted to the hospital within three months of discharge or transfer.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start30 Nov 2021
- Primary completion30 Jun 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Yunus BEKTAY, Bezmialem Vakif University
- Investigators
- Fikret Vehbi Izzettin, Prof.Dr., Principal investigator, Bezmialem Vakıf Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193473
- Sponsor's protocol ID
- Pharm. Role in Cardiology
- Status last verified
- Jan 2024
- First submitted
- 5 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Clinical Pharmacy Services in Patients Receiving Antithrombotic Treatment
- ClinicalTrials.gov ID
- NCT06193473
- Acronym / sponsor ID
- Pharm. Role in Cardiology
- Conditions
- Cardiovascular Diseases, Drug Use
- Keywords
- clinical pharmacist, antithrombotic drugs, drug-related problems, cardiovascular diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical pharmacy services aim to enhance patient outcomes and reduce the risk of potential drug-related harm by offering patient-centred pharmaceutical care. In the hospital setting, clinical pharmacists collaborate with physicians as part of a multidisciplinary team to identify and prevent DRPs (Drug-related problems). Clinical pharmacist interventions encompass 'any action initiated by a pharmacist that directly results in patient management or a modification in medication.' The favourable clinical and economic impacts of interventions have been well-established for decades. Clinical pharmacists have played an important role in ensuring the effective and correct use of medicines in many settings.
This study aims to investigate the clinical pharmacy services provided by clinical pharmacists to patients receiving antithrombotic therapy. For this study, patients were divided into two groups: a control group and an intervention group. A comprehensive medication review will be conducted by the clinical pharmacist for both the control and intervention groups. Drug-related problems such as drug selection, dose errors, possible drug-drug interactions, and inappropriate drug use, will be identified. In the control group, no interventions will be made by the clinical pharmacist. In the intervention group, solution recommendations for identified and clinically significant issues will be presented to the physician, and the provided services will be documented. Furthermore, the groups will be evaluated for whether there are any hospital readmissions within 1 and 3 months following discharge for the patients.
Detailed description
Patients with cardiovascular disease are at significant risk for adverse drug events and medication errors. Moreover, the rate of use of high-risk drugs such as antithrombotic drugs is higher in these patients. In the literature, antithrombotics have been shown as one of the main causes of adverse drug events and drug-related hospitalizations. Therefore, follow-up of patients treated with antithrombotics is very important. Guideline-based therapy significantly reduces the risk of all-cause and cardiovascular (CV) death. Multidisciplinary antithrombotic management can play an important role in increasing prescribing physicians' adherence to guidelines. Effective interventions such as medication review, establishment of treatment protocols, education, and medication reconciliation at hospitalization and discharge can help increase adherence to the guideline. In patients receiving antithrombotic therapy, individual evaluation of drug therapy suitability, formulation of a drug treatment plan, dose adjustment, drug monitoring, detection and prevention of clinically important drug-drug interactions, and antithrombotic transition protocols should be considered. Such interventions must appropriately balance each individual's risk of thromboss and bleeding.
Pharmacists are recognized as leading healthcare professionals in detecting, resolving, and preventing DRPs. Assessments of the quality and value of pharmacist interventions remain crucial for the development of new pharmaceutical care services and for enhancing our understanding of the frequency and variety of DRPs observed in various clinical settings. The literature has demonstrated the impact of Clinical Pharmacy Services on cardiovascular patients. Collaborating with a clinical pharmacist during inpatient treatment has been shown to improve medication adherence, reduce adverse drug reactions, and minimize medication errors post-discharge. The benefits of these pharmacist-led services in reducing hospitalization and healthcare costs were emphasized. Clinical pharmacy services have contributed to an enhancement in healthcare quality without compromising patient well-being. Pharmacists can take on the responsibility of antithrombotic management, ensuring that patients receive the right medication, in the correct dosage, and for the appropriate duration from the initial consultation to outpatient follow-up. Increasing the continuity of pharmaceutical care will enhance patient outcomes and reduce costs.
In this study, two groups were established as control group and intervention group. In the control group, no interventions will be made by the Clinical Pharmacist. Within the intervention group, patient characteristics such as the length of hospital stay, reason for hospitalization, underlying conditions, and the appropriateness of prescribed medications were evaluated for the patients who received antithrombotic treatment and met the inclusion criteria. Through medication reviews, evaluations were made to identify drug-related problems and provide solutions to these problems. The clinical pharmacist provided recommendations to the physicians regarding significant clinically important problems. Additionally, follow-up was performed to determine whether the patients had a re-admission within 3 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group: Group in which only observation is made by the clinical pharmacist | No intervention | –For patients in this group, no intervention (i.e. recommendation) will be made to physicians by the clinical pharmacist. Within the intervention group, patient characteristics such as the length of hospital stay, reason for hospitalization, underlying conditions, and the appropriateness of prescribed medications were evaluated for the patients who received antithrombotic treatment and met the inclusion criteria. The participant will take standard treatment. Evaluations will be recorded. Follow-up was performed to determine whether the patients had a re-admission within 3 months. |
| Intervention Group: Group to which the clinical pharmacist makes recommendations | Experimental | Behavioral: Intervention Group: Group to which the clinical pharmacist makes recommendationsFor patients in this group, intervention (i.e. recommendation) will be made to physicians by the clinical pharmacist. Within the intervention group, patient characteristics such as the length of hospital stay, reason for hospitalization, underlying conditions, and the appropriateness of prescribed medications were evaluated for the patients who received antithrombotic treatment and met the inclusion criteria. Through medication reviews, evaluations were made to identify drug-related problems and provide solutions to these problems. The clinical pharmacist provided recommendations to the physicians regarding significant clinically important problems. Additionally, follow-up was performed to determine whether the patients had a re-admission within 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being 18 years and older.
- Receiving antithrombotic treatment.
- Having complete biochemical and complete blood count values collected at least twice, with two-day medication information fully entered into the hospital system.
- Patients who could be evaluated by the clinical pharmacist for at least 24 hours within the intervention group.
Key exclusion criteria (4 listed)
- Being under 18 years old.
- Not using antithrombotic medication.
- Patients whose biochemical and complete blood count values were not collected twice and whose two-day medication information was not fully recorded in the hospital system.
- Patients in the intervention group whom the clinical pharmacist did not see for at least 24 hours (weekend hospital admission followed by Monday morning discharge, Friday admission with weekend discharge, etc.) were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention Group: Group to which the clinical pharmacist makes recommendationsThe drugs administered to patients within 24-48 hours after hospitalization were recorded. A detailed medication review will be conducted by the clinical pharmacist during the participants' hospitalization.As a result of a comprehensive evaluation, recommendations were made to doctors regarding drug-related problems and were recorded. | Behavioural | Intervention Group: Group to which the clinical pharmacist makes recommendations |
Primary outcome
Acceptance rate of suggested intervention (number)
Time frame: From the date of randomization until there are 200 patient participants in each group. Average 1 year.
Acceptance rate of suggested intervention. Medication-related problems and recommendations are classified according to PCNE (Pharmaceutical Care Network Europe) version 9.1. It was recorded how many suggestions were made in the intervention group and how many of these suggestions were accepted.
Length of hospital stay (days)
Time frame: From date of randomization until the date of discharge from the hospital, assessed up to 1 year.
Length of hospital stay
Within three months readmission (number of patients re-admitted to hospital)
Time frame: Whether patients were readmitted to the hospital within three months of discharge or transfer.
In order to determine which group of patients has the highest number of hospital re-admissions and to evaluate whether there is a significant difference between the groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fikret Vehbi Izzettin, Prof.Dr. principal investigator
Bezmialem Vakıf Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group: Group to which the clinical pharmacist makes recommendations in people with Cardiovascular Diseases and Drug Use, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance rate of suggested intervention (number) (time frame: From the date of randomization until there are 200 patient participants in each group. Average 1 year.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.