NCT05564156

Brief Summary

Clinical pharmacists in the healthcare system are experts in therapeutics and the use of drugs. They routinely provide medication reviews and recommendations to patients and healthcare professionals. Clinical pharmacists are a scientifically valid source of information and give advice on the safe and appropriate use of medicines and pharmacoeconomics. Clinical pharmacist researchers produce, distribute and apply new information that contributes to improving health and quality of life. Thus, it is ensured that many of the drug treatment errors that occur after inappropriate therapeutic decisions are made at the point of prescribing are prevented In this investigation, the effects of clinical pharmacists on respiratory would be investigated. This research area will cover lower respiratory tract infections and chronic lung disease exacerbations with ICD-10 codes J05, J9-22, J40-47, J69, J85 -J86. In this study, two groups, control and intervention groups, were identified. In the control group; There will be no intervention done by the Clinical Pharmacist. Hospital stay, antimicrobial suitability, microbial resistance development, antimicrobial induced nephrotoxicity, infection-related mortality, pharmacoeconomic evaluation, re-hospitalization within 30 days after discharged, medication reconciliation report will be created, patients will be monitored for the detection and management of drug-related problems will be recorded in both control and intervention groups. In the intervention group; recommendations will be given to the physicians by the Clinical Pharmacist on the selection of antibiotics, drug suitability, dosage and route of administration advice, and determination of drug-related problems related to drugs used simultaneously.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
Last Updated

October 5, 2022

Status Verified

October 1, 2022

Enrollment Period

7 months

First QC Date

September 26, 2022

Last Update Submit

October 3, 2022

Conditions

Keywords

Clinical PharmacistDrug-Related ProblemsChest-DiseasesCognitive Pharmacy Services

Outcome Measures

Primary Outcomes (3)

  • Acceptance rate of suggested intervention

    Acceptance rate of suggested intervention

    Immediately after the intervention

  • Length of hospital stay

    Length of hospital stay

    Immediately after the discharge of the participant

  • 30-day readmission

    Readmission within 30 day

    30 day after the intervention/after the discharge of the each participant

Study Arms (2)

Control Group

NO INTERVENTION

In the control group; No intervention will be made by the investigators in this group. The participant will take standard treatment. Participant's length of stay in hospital, suitability of antibiotics used, development of microbial resistance, Antibiotic related nephrotoxicity due to infection, mortality data due to infection will be recorded, hospitalization will be questioned within 30 days after the patient is discharged, and a drug consensus report will be created, drug-related problems will be determined, and a pharmacoeconomic evaluation of all possible outcomes will be made. Evaluations will be recorded, but the investigators will take no action.

Intervention Group

EXPERIMENTAL

In the intervention group; The participant will take standard treatment and the clinical pharmacist services such as drug reconciliation by the investigators, medication review (Identification of drug-related problems, detection of possible unsuitable drugs), quality of life measurement, antibiotic selection, drug suitability, dose and route of administration advice, and concomitant medications are included. Suggestions will be made by the investigators to physicians about the solution to drug-related problems. Participants' length of hospital stay, suitability of antibiotics, development of microbial resistance, antibiotic-related nephrotoxicity due to infection, and mortality numbers due to infection will be recorded, hospitalization will be questioned within 30 days after discharge. The investigators will create a drug consensus report, drug-related problems will be determined, and a pharmacoeconomic evaluation of all possible outcomes will be accomplished by investigators.

Behavioral: Intervention groups

Interventions

The drugs used by the participants within 24-48 hours after hospitalization were recorded. In the case of new prescribing, the recommendations made by the investigators to the physician are recorded in intervention group. The medication reconciliation report will be evaluated before the discharge of the participants and possible omissions discussed with the physician in charge. A detailed medication review will be accomplished by the investigators during the hospitalization of the participants.

Intervention Group

Eligibility Criteria

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

You may qualify if:

  • Having any of the J05, J9-22, J40-47, J69, J85-J86 diagnoses specified in the ICD-10 guideline,
  • Patients hospitalized due to respiratory tract infection and using antibiotic drugs,
  • Being 18 years or older,
  • Having signed the written consent form to participate in the study.

You may not qualify if:

  • The consent form is not approved,
  • Not having the necessary cognitive abilities,
  • Being under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Mesut Sancar, Prof. Dr.

    Marmara University, Department of Clinical pharmacy

    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, Asistant Professor

Study Record Dates

First Submitted

September 26, 2022

First Posted

October 3, 2022

Study Start

June 30, 2020

Primary Completion

January 31, 2021

Study Completion

December 31, 2021

Last Updated

October 5, 2022

Record last verified: 2022-10

Locations