Development and Evaluation of Clinical Pharmacy Services in Respiratory Diseases

Sponsor
Bezmialem Vakif University (Other)
Overall Status
Completed
CT.gov ID
NCT05564156
Collaborator
Marmara University (Other)
168
1
2
18
9.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Intervention groups
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
168 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Health Services Research
Official Title:
Development and Evaluation of Clinical Pharmacy Services in Respiratory Diseases
Actual Study Start Date :
Jun 30, 2020
Actual Primary Completion Date :
Jan 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

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.

Behavioral: Intervention groups
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.

Outcome Measures

Primary Outcome Measures

  1. Acceptance rate of suggested intervention [Immediately after the intervention]

    Acceptance rate of suggested intervention

  2. Length of hospital stay [Immediately after the discharge of the participant]

    Length of hospital stay

  3. 30-day readmission [30 day after the intervention/after the discharge of the each participant]

    Readmission within 30 day

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bezmialem Vakif University Istanbul Turkey 34093

Sponsors and Collaborators

  • Bezmialem Vakif University
  • Marmara University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Muhammed Yunus BEKTAY, Principal Investigator, Asistant Professor, Bezmialem Vakif University
ClinicalTrials.gov Identifier:
NCT05564156
Other Study ID Numbers:
  • Pharm. Role Resp. Disease Ward
First Posted:
Oct 3, 2022
Last Update Posted:
Oct 5, 2022
Last Verified:
Oct 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Muhammed Yunus BEKTAY, Principal Investigator, Asistant Professor, Bezmialem Vakif University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 5, 2022