PneumoniaNCT05564156
Development and Evaluation of Clinical Pharmacy Services in Respiratory Diseases
A study testing Intervention groups in people with Pneumonia and COPD Asthma, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, COPD Asthma, COPD Exacerbation
- What is being tested?
- Intervention groups
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2020to 31 Dec 2021
- 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
- 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.
Who cannot join
- The consent form is not approved,
- Not having the necessary cognitive abilities,
- Being under the age of 18
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pneumonia, COPD Asthma, COPD Exacerbation
- Being tested
- Intervention groups
- Keywords
- Clinical Pharmacist, Drug-Related Problems, Chest-Diseases, Cognitive Pharmacy Services
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Intervention groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance rate of suggested intervention
Acceptance rate of suggested intervention
Measured: Immediately after the intervention
Length of hospital stay
Length of hospital stay
Measured: Immediately after the discharge of the participant
30-day readmission
Readmission within 30 day
Measured: 30 day after the intervention/after the discharge of the each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start30 Jun 2020
- Primary completion31 Jan 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Collaborators
- Marmara University
- Responsible party
- Principal investigator, Muhammed Yunus BEKTAY, Bezmialem Vakif University
- Investigators
- Mesut Sancar, Prof. Dr., Principal investigator, Marmara University, Department of Clinical pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564156
- Sponsor's protocol ID
- Pharm. Role Resp. Disease Ward
- Status last verified
- Oct 2022
- First submitted
- 26 Sep 2022
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of Clinical Pharmacy Services in Respiratory Diseases
- ClinicalTrials.gov ID
- NCT05564156
- Acronym / sponsor ID
- Pharm. Role Resp. Disease Ward
- Conditions
- Pneumonia, COPD Asthma, COPD Exacerbation
- Keywords
- Clinical Pharmacist, Drug-Related Problems, Chest-Diseases, Cognitive Pharmacy Services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Collaborators
- Marmara University
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Intervention groupsIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- The consent form is not approved,
- Not having the necessary cognitive abilities,
- Being under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention groupsThe 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. | Behavioural | Intervention Group |
Primary outcome
Acceptance rate of suggested intervention
Time frame: Immediately after the intervention
Acceptance rate of suggested intervention
Length of hospital stay
Time frame: Immediately after the discharge of the participant
Length of hospital stay
30-day readmission
Time frame: 30 day after the intervention/after the discharge of the each participant
Readmission within 30 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mesut Sancar, Prof. Dr. principal investigator
Marmara University, Department of Clinical pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention groups in people with Pneumonia and COPD Asthma, 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 3 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 Oct 2022. 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 (time frame: Immediately after the intervention). 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 Oct 2022.