Electronic Medical Record Review in Monitoring the Effects of Adherence on Myelosuppression and Morbidity in Patients With Newly Diagnosed Brain Tumors Receiving Temozolomide and Radiation Therapy

Completed

• Conditions: Brain Tumor
• Interventions: Other: medical chart review

• Registration Number: NCT02208336
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

This research trial studies electronic medical record review in monitoring the effects of adherence on myelosuppression and morbidity in patients with newly diagnosed brain tumors receiving temozolomide and radiation therapy. Myelosuppression is a condition in which bone marrow activity is decreased, resulting in fewer red blood cells, white blood cells, and platelets and is a side effect of some cancer treatments. Morbidity is a term that refers to having a symptom of disease or medical problems caused by a treatment. Monitoring patients' electronic medical records to compare side effects, such as myelosuppression and morbidity, with treatment adherence may be a way to enhance patient care by organizing data for medical staff.

Detailed Description

PRIMARY OBJECTIVES:

I. Retrospectively measure the frequency of nonadherence with established monitoring guidelines in the target patient population.

II. Retrospectively assess the impact of nonadherence events on myelosuppression severity and patient morbidity.

III. Prospectively measure the effect of an automated notification program on adherence rates.

SECONDARY OBJECTIVES:

I. Quantify any time savings realized by patient care staff through the use of such a program.

II. Quantify the number of patient care interventions that directly result from this automated monitoring and notification program.

OUTLINE:

Patients' electronic medical records are reviewed for adherence, severe myelosuppression, and patient morbidity retrospectively and prospectively.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2014-08-01
• Study First Submitted QC: 2014-08-01
• Study First Posted: 2014-08-05
• Primary Completion: 2015-02-23
• Study Completion: 2015-02-23
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-17
• Last Update Posted: 2017-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

• RETROSPECTIVE: All patients seen in Dr. Lesser's clinic who received concurrent temozolomide and radiation therapy followed by adjuvant temozolomide for newly diagnosed malignant gliomas from 01/01/07 through 03/31/2010 will be analyzed
• PROSPECTIVE: All patients seen in Dr. Lesser's clinic who receive concurrent temozolomide and radiation therapy followed by adjuvant temozolomide for newly diagnosed malignant gliomas during and after the construction of the system until the end of the study

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Exclusion Criteria

• Patients participating in clinical trials or other deviations from non-standard therapies that engender similar monitoring risk will be evaluated for this study on a case by case basis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (electronic medical record review)	medical chart review	Patients' electronic medical records are reviewed for adherence, severe myelosuppression, and patient morbidity retrospectively and prospectively.

Primary Outcome Measures

Name	Time	Method
Frequency of nonadherence (retrospective)	Up to 42 days (completion of treatment)	A two-sided 95.0% confidence interval for a single proportion using the large sample normal approximation will be extended from 8.1% in the observed proportion for an expected proportion of 25% non-adherence.
Impact of nonadherence events on myelosuppression severity (retrospective)	Up to 90 days after completion of treatment	Severe myelosuppression will be defined as grade 3 or grade 4 myelosuppression from Common Terminology Criteria for Adverse Events version 3.0 criteria. The dates of any severe myelosuppressive events will be recorded. A Fisher's exact test with a 0.050 two-sided significance level will be used.
Impact of nonadherence events on patient morbidity (retrospective)	Up to 90 days after completion of treatment	Patient morbidity (including date of event) will be assessed on all participants with severe myelosuppression, and includes: death during treatment with temozolomide or up to 90 days after treatment, the number of transfusions received for myelosuppression during treatment with temozolomide or up to 90 days after treatment, and the length of the hospital stay for myelosuppression during treatment with temozolomide or up to 90 days after treatment. A Fisher's exact test with a 0.050 two-sided significance level will be used.
Effect of an automated notification program on adherence rates (prospective)	Up to 6 years	To compare the rates of adherence between the retrospective and prospective time periods, a Fisher's exact test with a 0.050 two-sided significance level will be used.

Trial Locations

Locations (1)

Comprehensive Cancer Center of Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States