AzTrials
AzTrials

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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT06193473
Study groupRoleWhat they receive
Control Group: Group in which only observation is made by the clinical pharmacistNo interventionFor 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 recommendationsExperimentalFor 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.

  1. 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.

  2. 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.

  3. 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.

  1. First posted5 Jan 2024
  2. Study start30 Nov 2021
  3. Primary completion30 Jun 2022
  4. Study completion30 Nov 2022

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in