Enhancement of the Prediction of Chemotherapy Prescribing Errors for Oncology Patients

NCT02435290 | Completed DMC

• 1 other identifier: 123456
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief 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. 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).

Conditions

Inappropriate Prescribing; Clinical Oncology

Keywords

prediction; prescribing error; risk factors

Outcome Measures

Primary Outcomes (1)

• prescribing errors average

  to determine the average number of prescribing errors per patient

  6 months

Secondary Outcomes (1)

• cancer staging

  6 months

Study Arms (1)

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 .

Behavioral: determine the incidence , type , and severity of prescribing errors in the oncology department

Interventions

determine the incidence , type , and severity of prescribing errors in the oncology department BEHAVIORAL

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. .

Also known as: report prescribing errors to the physician and solutions ., study the impact of newly addressed risk factors on prescribing errors.

patients with malignant cancer receiving chemotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

in- and out-patients, with proven malignant disease receiving chemotherapy

You may qualify if:

• in- and out-patients, with proven malignant disease receiving chemotherapy

You may not qualify if:

• Patients receiving experimental agents and
• patients who are too ill or unwilling to participate will be excluded.

Sponsors & Collaborators

• hadeer ehab: lead

MeSH Terms

Interventions

Sarcoglycans; Solutions

Intervention Hierarchy (Ancestors)

Dystrophin-Associated Proteins; Muscle Proteins; Contractile Proteins; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Membrane Glycoproteins; Pharmaceutical Preparations

Study Officials

• Nagwa A Sabri, clinical pharmacy professor

  Ain Shams University

  STUDY CHAIR

• Amr S Saad, clinical oncology lecturer

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: clinical pharmacist

Study Record Dates

• First Submitted: March 22, 2015
• First Posted: May 6, 2015
• Study Start: March 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 6, 2015

Record last verified: 2015-05