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

University of Michigan

Status: Completed

Conditions: Hazardous Material Handling; Occupational Health

Treatments: Behavioral: Hazardous materials online education and study feedback

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02283164

HUM00103873

Details and patient eligibility

About

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.

Full 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.

Enrollment: 396 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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396 participants in 2 patient groups

Treatment

Experimental group

Description:

Hazardous materials online education and study feedback

Treatment:

Behavioral: Hazardous materials online education and study feedback

Control then treatment

Active Comparator group

Description:

Hazardous materials online education and study feedback

Treatment:

Behavioral: Hazardous materials online education and study feedback