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Opioid OverdoseOPSNCT05008523

Opioids and Police Safety Study

A study testing Opioids and Police Safety Occupational Risk Reduction Training (OPS) and Opioids and Police Safety Occupational Risk Reduction Training (COVID) in people with Opioid Overdose, run by New York University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Overdose deaths are currently the largest cause of accidental death in the US and opioid-related overdose deaths constitute the overwhelming majority of these deaths. Demands for a knowledge-base for effective law enforcement interventions is growing. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Opioid Overdose
What is being tested?
Opioids and Police Safety Occupational Risk Reduction Training (OPS) and Opioids and Police Safety Occupational Risk Reduction Training (COVID)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
333 participants
Where
1 siteUnited States
Study dates
22 Jan 2021to 1 Mar 2024
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Active duty Police Officer

Who cannot join

  • Desk only- not active duty

Trial locations and contacts

1 site in 1 country.

United States1 site
  • New York University

    New York, New York, 10010

Other trials in United States

About this study

Official title: Evaluation of an Experimental Educational Module on Opioid-related Occupational Safety to Minimize Barriers toOverdose Response Among Police Officers

Overdose deaths are currently the largest cause of accidental death in the US and opioid-related overdose deaths constitute the overwhelming majority of these deaths. Demands for a knowledge-base for effective law enforcement interventions is growing. This proposed study is designed to provide a knowledge base regarding key obstacles and facilitators of the willingness and preparedness of police to administer naloxone and related risk reduction practices and evaluate the efficacy of a web-based opioid-related occupational safety and risk reduction curriculum. Findings from this study will be applied to the development and implementation of effective interventions for police officers aimed at harmonizing law enforcement practices with public health goals.

Read the detailed description

This application proposes to contribute to the harmonization of law enforcement practices and public health goals to combat rising morbidity and mortality rates associated with opioid-related overdose (OD). Police departments around the U.S. are increasingly making the OD reversal drug, naloxone, available to their officers. This intervention has the potential to greatly improve emergency response after an OD. The proportion of precincts mandating that officers carry naloxone remains small, however, and barriers remain that make adoption of these first-responder programs problematic. Lawsuits from police unions contesting naloxone- related mandates and occupational safety concerns, including the potential for needle stick injuries (HIV/HCV risk) and incidental contact with fentanyl-class substances, constitute barriers, as do stigma and concerns about legal jeopardy. The study team proposes to equip police with best-practices for minimizing workplace harms related to encounters with PWUO/PWID and the legal and practical knowledge to respond confidently to an OD without fear of legal jeopardy as well as reduce health risks to PWUOs and PWIDs associated with law enforcement. More than 10,000 law enforcement officers in Pennsylvania (roughly one third of all PA officers) have already received naloxone and OD response training from GetNaloxoneNow.org (GNN), a web-based intervention. With the support of county departments of health, harm reduction agencies, law enforcement, and district attorneys, the team proposes to adapt extant interventions for police to create an online training module aimed at reducing barriers to police engagement in OD response. Using a mixed-method design, organized around a pragmatic trial design, the study will achieve the following objectives:1) Adapt an occupational risk reduction (ORR) curriculum to add to a web-based OD response and naloxone training platform (GNN); 2) Describe naloxone use patterns, OD response experiences, and attitudes related to illicit opioid use among a sample (N = 300) of police officers in PA trained via the GNN platform; 3) Evaluate the relative effectiveness of ORR + GNN, compared with GNN-only, with respect to the following outcomes: a) rates of carrying naloxone while on/off-duty; b) rates of OD response in which naloxone is/isn't administered; c) numbers of referrals to treatment; d) numbers of syringes confiscated; and e) rates of information sharing with OD survivors and others. Mediators and moderators of efficacy will also be analyzed. 4) Document the range of psychosocial mechanisms underlying participant OD response engagement post-intervention. This study aims to remove barriers to life-saving police engagement with PWUO/PWID by focusing both on the safety of law enforcement and evidence-based and best-practices for working with persons at risk of an opioid OD. The study also will provide empirical evaluation of the diffusion of naloxone-based response among law enforcement.

Conditions
Opioid Overdose
Being tested
Opioids and Police Safety Occupational Risk Reduction Training (OPS), Opioids and Police Safety Occupational Risk Reduction Training (COVID)
Medical subject headings
Opiate Overdose

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Opioids and Police Safety Occupational Risk Reduction Training (OPS)Behavioural

    Also called OPS

    Potential participants are provided with a flyer with directions to enroll online. Groups are randomized by zip code (all participants with the same zip code receive the same training to avoid contamination by precinct) Both the experimental and control groups first take the online GetNaloxoneNow.org First Responder training; then the experimental group takes the online OPS training and the control group takes the online COVID training. Both groups take a pre-survey prior to both trainings and a post-survey after they complete both trainings. Both groups also receive (via email) a resource list with information that was provided in their respective trainings plus additional resources re: occupational risk reduction appropriate to each training. Every quarter for one year, participants are emailed a reminder to get back online to take the survey again.

  • Opioids and Police Safety Occupational Risk Reduction Training (COVID)Behavioural

    Also called COVID

    Potential participants are provided with a flyer with directions to enroll online. Groups are randomized by zip code (all participants with the same zip code receive the same training to avoid contamination by precinct) Both the experimental and control groups first take the online GetNaloxoneNow.org First Responder training; then the experimental group takes the online OPS training and the control group takes the online COVID training. Both groups take a pre-survey prior to both trainings and a post-survey after they complete both trainings. Both groups also receive (via email) a resource list with information that was provided in their respective trainings plus additional resources re: occupational risk reduction appropriate to each training. Every quarter for one year, participants are emailed a reminder to get back online to take the survey again.

Study groups in NCT05008523
Study groupRoleWhat they receive
Opioids and Police Safety Occupational Risk Reduction TrainingExperimentalProvides occupational risk reduction training for police in 49 slides including 8 filmed videos (police officers, MDs, SSP staff, a person in recovery). The training is delivered online with secure access only for enrolled study participants.
Receives: Behavioral: Opioids and Police Safety Occupational Risk Reduction Training (OPS)
COVID Occupational Risk Reduction TrainingActive comparatorThe COVID-19 and Police Safety training (Control only) includes 22 slides, also narrated by a professional voice narrator.
Receives: Behavioral: Opioids and Police Safety Occupational Risk Reduction Training (COVID)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Naloxone Behavioral Outcomes in Policing Procedure

    Number of days during the past 30 days in which participants had naloxone available and carried naloxone while at work.

    Measured: Time frame for all above items: the past 30 days at the time the survey is being administered; [Data collected: Baseline, Post Intervention: 90 days, 180 days, 270 days, 360 days]

  2. Change in Naloxone Behavioral Outcomes in Policing Procedure

    Number of days during the past 30 days in which participants had naloxone available and carried naloxone outside of work hours.

    Measured: Time frame for all above items: the past 30 days at the time the survey is being administered; [Data collected: Baseline, Post Intervention: 90 days, 180 days, 270 days, 360 days]

  3. Change in Naloxone Behavioral Outcomes in Policing Procedure

    Number of days during the past 30 days in which participants responded to an OD event, attempted to intervene, and/or administered naloxone.

    Measured: Time frame for all above items: the past 30 days at the time the survey is being administered; [Data collected: Baseline, Post Intervention: 90 days, 180 days, 270 days, 360 days]

  4. Change in Referral Behavioral Outcomes in Policing Procedure

    Number of referrals to evidence-based or other drug treatment or social services made during the past 30 days.

    Measured: Time frame: the past 30 days at the time the survey is being administered; [Data collected: Baseline, Post Intervention: 90 days, 180 days, 270 days, 360 days]

  5. Change in Confiscation Behavioral Outcomes in Policing Procedure

    Number of episodes involving syringe confiscation in the past 30 days (with/without proper technique).

    Measured: Time frame for all above items: the past 30 days at the time the survey is being administered; [Data collected: Baseline, Post Intervention: 90 days, 180 days, 270 days, 360 days]

  6. Change in Confiscation Behavioral Outcomes in Policing Procedure

    Number of episodes in the past 30 days involving drug confiscation (with/without proper technique).

    Measured: Time frame for all above items: the past 30 days at the time the survey is being administered; [Data collected: Baseline, Post Intervention: 90 days, 180 days, 270 days, 360 days]

Secondary outcomes (10)
  1. Change in participant knowledge about needle stick injury and treatment

    Which of the following diseases is MOST likely to be transmitted by a needle stick injury?

    Measured: [Data collected: Baseline, Post Intervention: 90 days, 180 days, 270 days, 360 days]

  2. Change in participant knowledge about needle stick injury and treatment

    The risk of getting a bloodborne infection as a result of a needle stick injury is high (check only one response).

    Measured: [Data collected: Baseline, Post Intervention: 90 days, 180 days, 270 days, 360 days]

  3. Change in participant knowledge about needle stick injury and treatment

    To avoid being stuck with a needle, police officers should (select ALL that apply)

    Measured: [Data collected: Baseline, Post Intervention: 90 days, 180 days, 270 days, 360 days]

  4. Change in participant knowledge about needle stick injury and treatment

    The evidentiary value of syringes and any drug residue therein is (fill in the blank by checking only one response).

    1. Possession of syringes is (fill in the blank by checking only one response). 6) Confiscating syringes from people who inject drugs... (check all that apply): 7) Testing and precautionary treatment of any NSI is important, because... (fill in the blank by checking only one response).

    Measured: [Data collected: Baseline, Post Intervention: 90 days, 180 days, 270 days, 360 days]

  5. Change in participant knowledge about needle stick injury and treatment

    Possession of syringes is (fill in the blank by checking only one response). 6) Confiscating syringes from people who inject drugs... (check all that apply): 7) Testing and precautionary treatment of any NSI is important, because... (fill in the blank by checking only one response).

    Measured: [Data collected: Baseline, Post Intervention: 90 days, 180 days, 270 days, 360 days]

  6. Change in participant knowledge about needle stick injury and treatment

    Confiscating syringes from people who inject drugs... (check all that apply):

    1. Testing and precautionary treatment of any NSI is important, because... (fill in the blank by checking only one response).

    Measured: [Data collected: Baseline, Post Intervention: 90 days, 180 days, 270 days, 360 days]

  7. Change in participant knowledge about needle stick injury and treatment

    Testing and precautionary treatment of any NSI is important, because... (fill in the blank by checking only one response).

    Measured: [Data collected: Baseline, Post Intervention: 90 days, 180 days, 270 days, 360 days]

  8. Degree of participant familiarity with proper technique for dealing with contaminated injection equipment

    Please indicate your agreement with the following statements relating to needle stick prevention and response (1 = strongly agree, 2 = agree, 3 = neither agree nor disagree, 4 = disagree, 5 = strongly disagree):

    1. I feel confident in my ability to avoid needlestick injuries.
    2. I feel confident in my ability to get people who inject drugs to tell me if they have sharps before I search them.
    3. I feel confident in my ability to conduct a Terry Stop with minimal risk of a needlestick injury.
    4. In the event of needle stick injury, I would know the response protocol.
    5. In the event of a needle stick injury, I feel confident in my ability to get the right testing and medical care.
    6. In the event of a needle stick injury, I feel comfortable talking to the owner of the needle about coming with me to get tested.

    Measured: [Data collected: Baseline, Post Intervention: 90 days, 180 days, 270 days, 360 days]

  9. Degree of participant awareness of post-exposure prophylaxis (PEP) and its uses

    (1 = strongly agree, 2 = agree, 3 = neither agree nor disagree, 4 = disagree, 5 = strongly disagree):

    1. A first responder's risk of experiencing an overdose from touching fentanyl is high (select one response)
    2. A first responder's risk of experiencing an overdose from breathing fentanyl is high (select one response)
    3. Possession of naloxone by civilians is authorized only when accompanied with a valid prescription (select one response)
    4. The 911 Good Samaritan Law... (fill in the blank and select all that apply)
    5. When called to an overdose scene, it is best practice for police officers to... (fill in the blank and select all that apply)

    Measured: [Data collected: Baseline, Post Intervention: 90 days, 180 days, 270 days, 360 days]

  10. Degree of participant awareness of risk of fentanyl exposure and proper technique for dealing with synthetic opioids

    Response options: (1 = all the time, 2 = most of the time, 3 = sometimes, 4 = rarely, 5 = never):

    1. I am confident that I won't overdose from incidental skin contact with fentanyl.
    2. I am confident about my ability to use basic protective equipment to avoid fentanyl exposure.
    3. I am confident that I can recognize an opioid overdose when I see it.
    4. I am confident that I can effectively reverse an overdose using rescue techniques and naloxone.
    5. I am confident that I know how to conduct myself at an overdose scene to safeguard public health and public safety.

    Measured: [Data collected: Baseline, Post Intervention: 90 days, 180 days, 270 days, 360 days]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2021
  2. Study start22 Jan 2021
  3. Primary completion10 Feb 2023
  4. Study completion1 Mar 2024 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Single group
Model description
The Opioids and Police Safety Study employed a pragmatic trial design evaluated in a simultaneous embedded mixed-method approach.
Masking
None (open label)
Enrolment
333 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05008523
Sponsor's protocol ID
IRB-FY2019-3315
Acronym
OPS
Status last verified
Mar 2023
First submitted
21 Jun 2021
Last updated
7 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Simmons J, Elliott L, Bennett AS, Beletsky L, Rajan S, Anders B, Dastparvardeh N. Evaluation of an Experimental Web-based Educational Module on Opioid-related Occupational Safety Among Police Officers: Protocol for a Randomized Pragmatic Trial to Minimize Barriers to Overdose Response. JMIR Res Protoc. 2022 Feb 25;11(2):e33451. doi: 10.2196/33451.

    PubMed 35212639

Questions about this trial

What is this clinical trial studying?

A study testing Opioids and Police Safety Occupational Risk Reduction Training (OPS) and Opioids and Police Safety Occupational Risk Reduction Training (COVID) in people with Opioid Overdose, run by New York University at 1 site in United States.

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 1 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: status not confirmed, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

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?

Change in Naloxone Behavioral Outcomes in Policing Procedure (time frame: Time frame for all above items: the past 30 days at the time the survey is being administered; [Data collected: Baseline, Post Intervention: 90 days, 180 days, 270 days, 360 days]). The study lists 6 primary outcomes in all. 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 NCT05008523, which also lists 1 linked publication.

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 7 Dec 2023.

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