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Completed

NCT Number: NCT02283164

Drug Exposure Feedback and Education for Nurses' Safety

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.

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Key information

Conditions

Occupational Health Hazardous Material Handling

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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:

  • Evaluate the efficacy of an audit and feedback intervention to improve recommended use of PPE;
  • Determine whether the intervention effects on PPE use are mediated by knowledge about PPE use and perceived risk of hazardous drug exposure, and;
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hazardous materials online education and study feedback

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    • 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.
    • 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

  2. 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:

    • Workloads will be measured by the number of patients participants had primary responsibility for on their last shift.
    • 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.
    • 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).

  3. Potential Moderators--Personal

    Time frame: Baseline (Year 1) and follow-up (Year 3)

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

    • nursing experience (years),
    • education (diploma, associate's degree, bachelor's degree, master's degree, post-master's degree)
    • certification (Oncology Nursing Society chemotherapy certification, Oncology Certified Nurse (OCN®), Advanced Oncology Certified Nurse (AOCN®), other certification)

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

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

Registry information

Official study title

Randomized Controlled Trial to Improve Oncology Nurses' Protective Equipment Use

Acronym: DEFENS

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Nov 5, 2014
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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