Drug Exposure Feedback and Education for Nurses' Safety

NCT ID: NCT02283164

Last Updated: 2019-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

396 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Occupational Health Hazardous Material Handling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Treatment

Hazardous materials online education and study feedback

Group Type EXPERIMENTAL

Hazardous materials online education and study feedback

Intervention Type 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.

Control then treatment

Hazardous materials online education and study feedback

Group Type ACTIVE_COMPARATOR

Hazardous materials online education and study feedback

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

FED

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Christopher R. Friese

Elizabeth Tone Hosmer Professor of Nursing

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher R Friese, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan School of Nursing

References

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Friese CR, Mendelsohn-Victor K, Wen B, Sun D, Sutcliffe K, Yang JJ, Ronis DL, McCullagh MC; DEFENS Study Investigators. DEFENS - Drug Exposure Feedback and Education for Nurses' Safety: study protocol for a randomized controlled trial. Trials. 2015 Apr 17;16:171. doi: 10.1186/s13063-015-0674-5.

Reference Type BACKGROUND
PMID: 25928792 (View on PubMed)

Friese CR, Yang J, Mendelsohn-Victor K, McCullagh M. Randomized Controlled Trial of an Intervention to Improve Nurses' Hazardous Drug Handling. Oncol Nurs Forum. 2019 Mar 1;46(2):248-256. doi: 10.1188/19.ONF.248-256.

Reference Type BACKGROUND
PMID: 30767961 (View on PubMed)

Other Identifiers

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HUM00103873

Identifier Type: -

Identifier Source: org_study_id

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