Occupational HealthDEFENSNCT02283164
Drug Exposure Feedback and Education for Nurses' Safety
A study testing Hazardous materials online education and study feedback in people with Occupational Health and Hazardous Material Handling, run by University of Michigan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Occupational Health, Hazardous Material Handling
- What is being tested?
- Hazardous materials online education and study feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 396 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- registered nurses
- employed 16 hours or more per week in the ambulatory chemotherapy infusion area
Who cannot join
- Treatment with an antineoplastic agent in the past year.
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Occupational Health, Hazardous Material Handling
- Being tested
- Hazardous materials online education and study feedback
- Keywords
- Occupational health, Hazardous material handling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hazardous materials online education and study feedbackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Hazardous materials online education and study feedback Receives: Behavioral: Hazardous materials online education and study feedback |
| Control then treatment | Active comparator | Hazardous materials online education and study feedback Receives: Behavioral: Hazardous materials online education and study feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usage of PPE
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.
Measured: Baseline (Year 1) and follow-up (Year 3)
Secondary outcomes (3)
Potential Mediators
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
Measured: Baseline (Year 1) and follow-up (Year 3)
Potential Moderators--Organization
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).
Measured: Baseline (Year 1) and follow-up (Year 3)
Potential Moderators--Personal
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)
Measured: Baseline (Year 1) and follow-up (Year 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startMar 2015
- Primary completionApr 2017
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Occupational HealthStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Responsible party
- Principal investigator, Christopher R. Friese, University of Michigan
- Investigators
- Christopher R Friese, PhD, Principal investigator, University of Michigan School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02283164
- Sponsor's protocol ID
- HUM00103873
- Acronym
- DEFENS
- Status last verified
- Aug 2019
- First submitted
- 31 Oct 2014
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25928792Friese 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.
PubMed 30767961
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Improve Oncology Nurses' Protective Equipment Use
- ClinicalTrials.gov ID
- NCT02283164
- Acronym / sponsor ID
- DEFENS / HUM00103873
- Conditions
- Occupational Health, Hazardous Material Handling
- Keywords
- Occupational health, Hazardous material handling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Study start
- Mar 2015 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 5 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Hazardous materials online education and study feedbackHazardous materials online education and study feedback |
| Control then treatment | Active comparator | Behavioral: Hazardous materials online education and study feedbackHazardous materials online education and study feedback |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- registered nurses
- employed 16 hours or more per week in the ambulatory chemotherapy infusion area
Key exclusion criteria (1 listed)
- Treatment with an antineoplastic agent in the past year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hazardous materials online education and study feedbackParticipants 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. | Behavioural | Control then treatment, Treatment |
Primary outcome
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.
3 secondary outcomes
Potential Mediators
Time frame: Baseline (Year 1) and follow-up (Year 3)
Potential Moderators--Organization
Time frame: Baseline (Year 1) and follow-up (Year 3)
Potential Moderators--Personal
Time frame: Baseline (Year 1) and follow-up (Year 3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Background: PubMed 25928792Friese 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.
- Background: PubMed 30767961Friese 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher R Friese, PhD principal investigator
University of Michigan School of Nursing
Questions about this trial
What is this clinical trial studying?
A study testing Hazardous materials online education and study feedback in people with Occupational Health and Hazardous Material Handling, run by University of Michigan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usage of PPE (time frame: Baseline (Year 1) and follow-up (Year 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02283164, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019.