NCT06193473

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 5, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

7 months

First QC Date

December 5, 2023

Last Update Submit

January 4, 2024

Conditions

Keywords

clinical pharmacistantithrombotic drugsdrug-related problemscardiovascular diseases

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    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.

    Whether patients were readmitted to the hospital within three months of discharge or transfer.

Study Arms (2)

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.

Behavioral: Intervention Group: Group to which the clinical pharmacist makes recommendations

Interventions

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.

Intervention Group: Group to which the clinical pharmacist makes recommendations

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakıf Üniversitesi

Istanbul, Fatih, 34096, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Fikret Vehbi Izzettin, Prof.Dr.

    Bezmialem Vakıf Üniversitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 5, 2023

First Posted

January 5, 2024

Study Start

November 30, 2021

Primary Completion

June 30, 2022

Study Completion

November 30, 2022

Last Updated

January 5, 2024

Record last verified: 2024-01

Locations