Drug Exposure Feedback and Education for Nurses' Safety (DEFENS)

August 30, 2019 updated by: Christopher R. Friese, University of Michigan

Randomized Controlled Trial to Improve Oncology Nurses' Protective Equipment Use

The goal of this research is to evaluate the efficacy of an audit and feedback intervention to improve personal protective equipment (PPE) use by nurses who handle hazardous drugs in the ambulatory oncology setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The overall objective of the proposed study is to investigate exposures to hazardous antineoplastic drugs among oncology nurses who handle them. The specific project objective is to evaluate the efficacy of an audit and feedback intervention to improve PPE use by nurses who handle hazardous drugs in the ambulatory oncology setting. This project will pursue three specific aims:

  1. Evaluate the efficacy of an audit and feedback intervention to improve recommended use of PPE;
  2. Determine whether the intervention effects on PPE use are mediated by knowledge about PPE use and perceived risk of hazardous drug exposure, and;
  3. Determine whether the intervention effects on PPE use are moderated by personal (experience, education, certification) and organizational factors (workloads, practice environments, safety organizing).

To achieve these aims, 382 nurses employed in 11 oncology centers will participate in a cluster randomized controlled trial. Sites will be randomized so participants will receive a one-hour web-based educational module on hazardous drug safe handling with quarterly email reminders about the educational content (control) or the web-based educational module plus quarterly feedback on hazardous drug spills and drug levels measured in the study population (treatment). The hypothesis is that nurses in sites who receive the treatment will report significantly higher PPE use compared to nurses in sites assigned to receive the control. Data will also identify organizational factors that can be targeted for future interventions.

Study Type

Interventional

Enrollment (Actual)

396

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • registered nurses
  • employed 16 hours or more per week in the ambulatory chemotherapy infusion area

Exclusion Criteria:

  • Treatment with an antineoplastic agent in the past year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Hazardous materials online education and study feedback
Behavioral: Hazardous materials online education and study feedback
Participants will receive a 45-minute educational webinar on hazardous materials handing best practices at the beginning of the intervention period. Subsequently they will receive quarterly feedback of interim study results.
Active Comparator: Control then treatment
Hazardous materials online education and study feedback
Behavioral: Hazardous materials online education and study feedback
Participants will receive a 45-minute educational webinar on hazardous materials handing best practices at the beginning of the intervention period. Subsequently they will receive quarterly feedback of interim study results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usage of PPE
Time Frame: Baseline (Year 1) and follow-up (Year 3)
Use of PPE is measured on a 6-point Likert scale (5=always, 4=76-99% of the time, 3=51-75%, 2=26-50%, 1=1-25%, and 0=never). A mean score is calculated for each participant across 5 items: use of chemotherapy gloves, double gloves, single-use disposable gowns, eye protection, and respirators. Higher scores reflect more frequent use of PPE elements.
Baseline (Year 1) and follow-up (Year 3)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Potential Mediators
Time Frame: Baseline (Year 1) and follow-up (Year 3)

Knowledge of PPE and perceived risk of hazardous drug exposure are hypothesized to mediate the potential effects of the intervention on PPE use.

  1. Knowledge of PPE will be measured using a 10-item chemotherapy exposure knowledge scale. Individual questions about drug exposure are multiple choice. Correct answers are scored as 1 and incorrect answers are scored as 0. The scale range is 0-10, with higher scores reflecting increased knowledge.
  2. Perceived risk of drug exposure will be measured using a 3-item subscale from Geer's Occupational Dermal Survey. A 4-point Likert scale (1=strongly disagree, 4=strongly agree) will be used to assess nurses' perceptions of the risks of chemotherapy exposure and potential health effects
Baseline (Year 1) and follow-up (Year 3)
Potential Moderators--Organization
Time Frame: Baseline (Year 1) and follow-up (Year 3)

Three organizational factors (workloads, practice environments, and safety organizing) are proposed moderators:

  1. Workloads will be measured by the number of patients participants had primary responsibility for on their last shift.
  2. The practice environment will be measured by calculating the average of a 23-item composite measure across six domains: nurse participation in practice affairs, nursing foundations for quality care, nurse manager support and leadership, collegial nurse-physician relations, staffing and resource adequacy, and medical assistant support. Items are scored on a 5-point Likert scale, where 1=strongly disagree to 5=strongly agree the characteristic is present in the practice.
  3. The Safety Organizing Scale (SOS) reflects theoretically derived and empirically observed content domains in high-reliability organizations that avert operational failure. Each item is scored on a 7-point Likert scale (1=not at all, 7=to a very great extent).
Baseline (Year 1) and follow-up (Year 3)
Potential Moderators--Personal
Time Frame: Baseline (Year 1) and follow-up (Year 3)

Three personal factors (experience, education, and certification) are proposed moderators.

  1. nursing experience (years),
  2. education (diploma, associate's degree, bachelor's degree, master's degree, post-master's degree)
  3. certification (Oncology Nursing Society chemotherapy certification, Oncology Certified Nurse (OCN®), Advanced Oncology Certified Nurse (AOCN®), other certification)
Baseline (Year 1) and follow-up (Year 3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Institute for Occupational Safety and Health (NIOSH/CDC)

Investigators

  • Principal Investigator: Christopher R Friese, PhD, University of Michigan School of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

October 31, 2014

First Submitted That Met QC Criteria

October 31, 2014

First Posted (Estimate)

November 5, 2014

Study Record Updates

Last Update Posted (Actual)

September 4, 2019

Last Update Submitted That Met QC Criteria

August 30, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HUM00103873

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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