Development and Evaluation of Clinical Pharmacy Services in Respiratory Diseases

October 3, 2022 updated by: Muhammed Yunus BEKTAY, Bezmialem Vakif University

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

The literature shows the benefit of including the pharmacist in microbiological test review and follow-up. The inclusion of a pharmacist in antibiotic management processes can result in the more reasonable use of antimicrobial agents and more efficient monitoring with patients and/or caregivers. Healthcare policymakers and administrators who evaluate processes to increase efficiency and improve care for patients suspected of discharged infections should examine the effectiveness of clinical pharmacists in the CAP.

Urgent action is needed to tackle the growing resistance threat. Antimicrobial stewardship programs (AYP) have resulted in slowing down antimicrobial resistance and improving antimicrobial prescribing practices that can maintain existing antimicrobial treatments. The CDC and Joint Commission have published recommendations and standards for the conduct of antimicrobial management in both inpatient and outpatient treatment. Although the main principles of the program of antimicrobial management have been established for over a decade, AYPs are constantly evolving, and improving program efficiency brings new approaches to patient care. Although it is one of the main goals of antimicrobial management, the direct effects of AYP interventions on reducing antimicrobial resistance are often immeasurable and multi-factorial. Therefore, interventions aimed at minimizing the use of inappropriate antibiotics, including unnecessary and insufficient use, are often used to measure the effect of AYPs on resistance.

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.

Clinical pharmacists care about patients in all healthcare areas. They do not only provide clinical services, but they also provide care to their patients and they can perform this application in any application environment. In other words, clinical pharmacists interact and observe directly with the patient. Also, managing treatment directly in patient care settings is particularly important as it reinforces the existing definitions of the term "clinical". In addition, this specialization is used proactively to provide and advance rational drug therapy. 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 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.

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey, 34093
        • Bezmialem Vakif University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control Group
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.
EXPERIMENTAL: Intervention Group

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptance rate of suggested intervention
Time Frame: Immediately after the intervention
Acceptance rate of suggested intervention
Immediately after the intervention
Length of hospital stay
Time Frame: Immediately after the discharge of the participant
Length of hospital stay
Immediately after the discharge of the participant
30-day readmission
Time Frame: 30 day after the intervention/after the discharge of the each participant
Readmission within 30 day
30 day after the intervention/after the discharge of the each participant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Mesut Sancar, Prof. Dr., Marmara University, Department of Clinical pharmacy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 30, 2020

Primary Completion (ACTUAL)

January 31, 2021

Study Completion (ACTUAL)

December 31, 2021

Study Registration Dates

First Submitted

September 26, 2022

First Submitted That Met QC Criteria

September 30, 2022

First Posted (ACTUAL)

October 3, 2022

Study Record Updates

Last Update Posted (ACTUAL)

October 5, 2022

Last Update Submitted That Met QC Criteria

October 3, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pharm. Role Resp. Disease Ward

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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