Inappropriate PrescribingNCT02435290
Enhancement of the Prediction of Chemotherapy Prescribing Errors for Oncology Patients
An observational study of Inappropriate Prescribing and Clinical Oncology, run by hadeer ehab.
Trial summary
It is a cross-sectional study examining a random sample of in- and out-patients, with proven malignant disease receiving chemotherapy, over a period of 6 months from the start of the study who visit the Oncology department, Ain Shams University Teaching Hospitals. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inappropriate Prescribing, Clinical Oncology
- What is being tested?
- determine the incidence , type , and severity of prescribing errors in the oncology department
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Mar 2015
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: in- and out-patients, with proven malignant disease receiving chemotherapy
Who may be able to join
- in- and out-patients, with proven malignant disease receiving chemotherapy
Who cannot join
- Patients receiving experimental agents and
- patients who are too ill or unwilling to participate will be excluded.
About this study
Official title: Cross-sectional Study to Enhance the Prediction of Prescribing Errors for Oncology Patients
It is a cross-sectional study examining a random sample of in- and out-patients, with proven malignant disease receiving chemotherapy, over a period of 6 months from the start of the study who visit the Oncology department, Ain Shams University Teaching Hospitals. The effect of some risk factors on the prescribing error will be studied; these risk factors include the following: Tumor type ,Cancer stage ,type of comorbid illness ,type of medication , type of anti-cancer treatment , number of abnormal lab data ,type of abnormal lab data , the number of drugs in the treatment regimen , the number of side effects after chemotherapy administration, the age of patient ,the dosing frequency of anticancer ,the route of administration .
Summary statistics are performed to describe patient characteristics , frequency, types and classification of medication error; and frequency with which Medication errors occur.
Logistic regression will be applied to the collected data to perform a predictive relation between the risk factors which may be (categorical, continuous, or discrete) and the prescribing errors which are (categorical).
Read the detailed description
This study will be performed according to the hospital's ethics board. Data on age, cancer diagnosis, cancer stage, comorbid illness, details of the anticancer treatment, and drugs for comorbid illness as well as any laboratory abnormalities will be collected.The data will be collected from medical records review.Progress notes and changes made to patients' medication orders since admission are reviewed.
Drugs are classified as either "active agents" (defined as medications to treat cancer- and/or therapy-related symptoms) or "medications to treat comorbid conditions." A comorbid illness is defined as a non-cancer clinical condition that required pharmacologic treatment .
Prescribing errors will be classified as:
- Incorrect Medication: Medication ordered was not appropriate for patient based on indication, patient-specific variables, or clinical status.
- Medication Omission Error: patient having an indication for which no treatment or inadequate treatment was prescribed.
- Dose error: Under or over dosage of more than 5% of antineoplastic drugs .
- Dose omission: unspecified dosage for the medications.
- Incorrect Treatment Duration: Medication prescribed without an appropriate stop time.
- Potential drug-drug interactions: a modification of the effect of a drug when administered with another drug.
- Duplicate prescribing: two or more drugs from the same class are prescribed to treat the same condition, or different conditions.
- Omitted or improper route of administration: unspecified route, wrong route, or improper route to the patient clinical status.
- Improper medication infusion rate: wrong infusion rate for medications administrated via intravenous route.
The prescribing errors will be identified utilizing:
- Clinical Oncology guidelines of Ain shams university hospitals.
- BC cancer agency (BCCA) cancer drug manual
- .the web site chemocalculator (will be used to identify errors in dose calculation).
4- .Drugs.com (used to identify drug-drug interaction, route of administration errors, dose errors, and infusion rate errors).
5-- Manual search for chemotherapy prescribing errors articles via pubmed., and science direct.
Prescribing errors will be schemed into 3 levels according to their scientific evidence.
- Established: error confirmed by large clinical trials.
- Probable: error with high likelihood of occurrence but without definitive randomized clinical trials.
- Suspect: error likely to occur; data derived from case reports. To confirm the scientific evidence of the error, the investigators need to search BC Cancer Agency , pubmed, science direct and, medical journals literature to ensure the scientific evidence of the error. Reporting medication errors of scientific evidence from 1 to 3 to the physicians via e-mail.
Ranking the severity of the prescribing errors ,in which major, when the potential error could lead to permanent damage or risk of death; moderate, when the clinical consequence of an error requires medical treatment; or minor, when small or no clinical effect is expected from the error .
Clinical pharmacist will discuss and study the effect of the following risk factors on prescribing error:
- The tumor type (breast cancer, lymphoma and myeloma ,lung cancer ,genitourinary cancer ,gynecological cancer , GIT cancer, melanoma,head and neck cancer).
- Cancer stage.
- early: indicates Carcinoma in situ
- : locally- advanced: indicate more extensive disease: Larger tumor size and/or spread of the cancer beyond the organ in which it first developed to nearby lymph nodes and/or tissues or organs adjacent to the location of the primary tumor
- metastatic : indicates The cancer has spread to distant tissues or organs.
- Type of comorbid illness (heart disease /renal disease /hepatic disease /diabetes/ hypertension / gastric disease/ blood abnormality/ osteoporosis).
- The number of drugs in the treatment regimen .
- Type of medication ( active agent ,comorbid illness medication )
- Type of anticancer treatment
- The route of administration of chemotherapy (intravenous, intramuscular, Oral, Intrathecal).
- Dosing Frequency of treatment.
- The number of side effects of chemotherapy administrated experienced by the patient.
- The number of abnormal lab data.
- The type of abnormal lab data (kidney function test ,liver function test ,blood test ).
- The age of patient. Summary statistics of the data will be performed to determine the incidence of prescribing errors in the oncology department of Ain shams university hospitals.
Logistic regression analysis of the data will be performed using SPSS.
- Dependent variable is the presence or absence of prescribing error for which there is reasonable supportive evidence (i.e., scientific evidence levels 1 - 3).
- Explanatory variables (risk factors) are age, cancer type, cancer stage, treatment type, type of comorbid illness, number of drugs, type of medications, the number of laboratory abnormality, type of lab abnormality the route of administration, the frequency of treatment.
Logistic regression is used to model the determinants and predict the likelihood of the prescribing errors in the oncology department, Ain shams university hospital. The impact (coefficient) of each risk factor will be quantitatively correlated to prescribing errors.
Charts will be performed to inform physicians of the prescribing errors of high incidence, as well as, the risk factors increasing the likelihood of prescribing errors.
- Conditions
- Inappropriate Prescribing, Clinical Oncology
- Being tested
- determine the incidence , type , and severity of prescribing errors in the oncology department
- Keywords
- prediction, prescribing error, risk factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
determine the incidence , type , and severity of prescribing errors in the oncology departmentBehavioural
Also called report prescribing errors to the physician and solutions ., study the impact of newly addressed risk factors on prescribing errors.
patients' files are revised according to BCCA reference protocols to report errors which are categorized according to type,and severity including: BSA calculation, the eligibility of the chemotherapy protocol , the dosage form ,dosage , the modification of doses according to toxicity and laboratory data results ,frequency ,duration of treatment , intention of treatment , the omitted or duplicated medications ,and the drug interactions.
the impact of the risk factors on the incidence , and type of prescribing errors are studied including :The tumor type, Cancer stage , co morbid illness,The number of drugs in the treatment regimen ,The route of administration of chemotherapy ,Dosing Frequency of treatment, The toxicity of chemotherapy experienced by the patient, The number of abnormal lab data,The type of abnormal lab data ,the age of patient.
.
| Study group | Role | What they receive |
|---|---|---|
| patients with malignant cancer receiving chemotherapy | five hundred patients suffering malignant cancer from eight wards ( breast , GIT ,gynecological , genitourinary , lung , head and neck, lymphoma and myeloma ,skin and melanoma) ,receiving various chemotherapy protocols . Receives: Behavioral: determine the incidence , type , and severity of prescribing errors in the oncology department |
What is being measured
The primary outcome is the main question the study is designed to answer.
prescribing errors average
to determine the average number of prescribing errors per patient
Measured: 6 months
Secondary outcomes (1)
cancer staging
to determine the enhancement or progression of cancer staging
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startMar 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inappropriate PrescribingStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- hadeer ehab
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, hadeer ehab, Ain Shams University
- Investigators
- Nagwa A Sabri, clinical pharmacy professor, Study chair, Ain Shams UniversityAmr S Saad, clinical oncology lecturer, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435290
- Sponsor's protocol ID
- 123456
- Status last verified
- May 2015
- First submitted
- 22 Mar 2015
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional Study to Enhance the Prediction of Prescribing Errors for Oncology Patients
- ClinicalTrials.gov ID
- NCT02435290
- Acronym / sponsor ID
- 123456
- Conditions
- Inappropriate Prescribing, Clinical Oncology
- Keywords
- prediction, prescribing error, risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- hadeer ehabUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 6 May 2015 (estimated)
- 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.
It is a cross-sectional study examining a random sample of in- and out-patients, with proven malignant disease receiving chemotherapy, over a period of 6 months from the start of the study who visit the Oncology department, Ain Shams University Teaching Hospitals. The effect of some risk factors on the prescribing error will be studied; these risk factors include the following: Tumor type ,Cancer stage ,type of comorbid illness ,type of medication , type of anti-cancer treatment , number of abnormal lab data ,type of abnormal lab data , the number of drugs in the treatment regimen , the number of side effects after chemotherapy administration, the age of patient ,the dosing frequency of anticancer ,the route of administration .
Summary statistics are performed to describe patient characteristics , frequency, types and classification of medication error; and frequency with which Medication errors occur.
Logistic regression will be applied to the collected data to perform a predictive relation between the risk factors which may be (categorical, continuous, or discrete) and the prescribing errors which are (categorical).
Detailed description
This study will be performed according to the hospital's ethics board. Data on age, cancer diagnosis, cancer stage, comorbid illness, details of the anticancer treatment, and drugs for comorbid illness as well as any laboratory abnormalities will be collected.The data will be collected from medical records review.Progress notes and changes made to patients' medication orders since admission are reviewed.
Drugs are classified as either "active agents" (defined as medications to treat cancer- and/or therapy-related symptoms) or "medications to treat comorbid conditions." A comorbid illness is defined as a non-cancer clinical condition that required pharmacologic treatment .
Prescribing errors will be classified as:
- Incorrect Medication: Medication ordered was not appropriate for patient based on indication, patient-specific variables, or clinical status.
- Medication Omission Error: patient having an indication for which no treatment or inadequate treatment was prescribed.
- Dose error: Under or over dosage of more than 5% of antineoplastic drugs .
- Dose omission: unspecified dosage for the medications.
- Incorrect Treatment Duration: Medication prescribed without an appropriate stop time.
- Potential drug-drug interactions: a modification of the effect of a drug when administered with another drug.
- Duplicate prescribing: two or more drugs from the same class are prescribed to treat the same condition, or different conditions.
- Omitted or improper route of administration: unspecified route, wrong route, or improper route to the patient clinical status.
- Improper medication infusion rate: wrong infusion rate for medications administrated via intravenous route.
The prescribing errors will be identified utilizing:
- Clinical Oncology guidelines of Ain shams university hospitals.
- BC cancer agency (BCCA) cancer drug manual
- .the web site chemocalculator (will be used to identify errors in dose calculation).
4- .Drugs.com (used to identify drug-drug interaction, route of administration errors, dose errors, and infusion rate errors).
5-- Manual search for chemotherapy prescribing errors articles via pubmed., and science direct.
Prescribing errors will be schemed into 3 levels according to their scientific evidence.
- Established: error confirmed by large clinical trials.
- Probable: error with high likelihood of occurrence but without definitive randomized clinical trials.
- Suspect: error likely to occur; data derived from case reports. To confirm the scientific evidence of the error, the investigators need to search BC Cancer Agency , pubmed, science direct and, medical journals literature to ensure the scientific evidence of the error. Reporting medication errors of scientific evidence from 1 to 3 to the physicians via e-mail.
Ranking the severity of the prescribing errors ,in which major, when the potential error could lead to permanent damage or risk of death; moderate, when the clinical consequence of an error requires medical treatment; or minor, when small or no clinical effect is expected from the error .
Clinical pharmacist will discuss and study the effect of the following risk factors on prescribing error:
- The tumor type (breast cancer, lymphoma and myeloma ,lung cancer ,genitourinary cancer ,gynecological cancer , GIT cancer, melanoma,head and neck cancer).
- Cancer stage.
- early: indicates Carcinoma in situ
- : locally- advanced: indicate more extensive disease: Larger tumor size and/or spread of the cancer beyond the organ in which it first developed to nearby lymph nodes and/or tissues or organs adjacent to the location of the primary tumor
- metastatic : indicates The cancer has spread to distant tissues or organs.
- Type of comorbid illness (heart disease /renal disease /hepatic disease /diabetes/ hypertension / gastric disease/ blood abnormality/ osteoporosis).
- The number of drugs in the treatment regimen .
- Type of medication ( active agent ,comorbid illness medication )
- Type of anticancer treatment
- The route of administration of chemotherapy (intravenous, intramuscular, Oral, Intrathecal).
- Dosing Frequency of treatment.
- The number of side effects of chemotherapy administrated experienced by the patient.
- The number of abnormal lab data.
- The type of abnormal lab data (kidney function test ,liver function test ,blood test ).
- The age of patient. Summary statistics of the data will be performed to determine the incidence of prescribing errors in the oncology department of Ain shams university hospitals.
Logistic regression analysis of the data will be performed using SPSS.
- Dependent variable is the presence or absence of prescribing error for which there is reasonable supportive evidence (i.e., scientific evidence levels 1 - 3).
- Explanatory variables (risk factors) are age, cancer type, cancer stage, treatment type, type of comorbid illness, number of drugs, type of medications, the number of laboratory abnormality, type of lab abnormality the route of administration, the frequency of treatment.
Logistic regression is used to model the determinants and predict the likelihood of the prescribing errors in the oncology department, Ain shams university hospital. The impact (coefficient) of each risk factor will be quantitatively correlated to prescribing errors.
Charts will be performed to inform physicians of the prescribing errors of high incidence, as well as, the risk factors increasing the likelihood of prescribing errors.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with malignant cancer receiving chemotherapy | – | Behavioral: determine the incidence , type , and severity of prescribing errors in the oncology departmentfive hundred patients suffering malignant cancer from eight wards ( breast , GIT ,gynecological , genitourinary , lung , head and neck, lymphoma and myeloma ,skin and melanoma) ,receiving various chemotherapy protocols . |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- in- and out-patients, with proven malignant disease receiving chemotherapy
Key inclusion criteria (1 listed)
- in- and out-patients, with proven malignant disease receiving chemotherapy
Key exclusion criteria (2 listed)
- Patients receiving experimental agents and
- patients who are too ill or unwilling to participate will be excluded.
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 |
|---|---|---|
| determine the incidence , type , and severity of prescribing errors in the oncology departmentAlso: report prescribing errors to the physician and solutions ., study the impact of newly addressed risk factors on prescribing errors.patients' files are revised according to BCCA reference protocols to report errors which are categorized according to type,and severity including: BSA calculation, the eligibility of the chemotherapy protocol , the dosage form ,dosage , the modification of doses according to toxicity and laboratory data results ,frequency ,duration of treatment , intention of treatment , the omitted or duplicated medications ,and the drug interactions. the impact of the risk factors on the incidence , and type of prescribing errors are studied including :The tumor type, Cancer stage , co morbid illness,The number of drugs in the treatment regimen ,The route of administration of chemotherapy ,Dosing Frequency of treatment, The toxicity of chemotherapy experienced by the patient, The number of abnormal lab data,The type of abnormal lab data ,the age of patient. . | Behavioural | patients with malignant cancer receiving chemotherapy |
Primary outcome
prescribing errors average
Time frame: 6 months
to determine the average number of prescribing errors per patient
1 secondary outcome
cancer staging
Time frame: 6 months
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 6 May 2015.
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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.
Nagwa A Sabri, clinical pharmacy professor study chair
Ain Shams University
Amr S Saad, clinical oncology lecturer study director
Ain Shams University
Questions about this trial
What is this clinical trial studying?
An observational study of Inappropriate Prescribing and Clinical Oncology, run by hadeer ehab.
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 1 inclusion and 2 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 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
prescribing errors average (time frame: 6 months). 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 6 May 2015.