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Substance Use DisordersNCT05218681

Nursing Attitudes Towards SUD

A study testing Unit-based "Person First" Anti-stigma Awareness Rounds and Individual Text-based Messaging in people with Substance Use Disorders and Stigma, Social, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose is to measure substance use disorder (SUD)-related stigma among hospital-based nurses using validated survey instruments, and attempt to reduce stigma through a combination of individual and unit-based educational and participatory interventions. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Substance Use Disorders, Stigma, Social
What is being tested?
Unit-based "Person First" Anti-stigma Awareness Rounds and Individual Text-based Messaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
1 siteUnited States
Study dates
17 Nov 2021to 8 Aug 2022
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

  • Registered nurses working in any capacity (bedside, administration) at the Hospital of the University of Pennsylvania.

Who cannot join

  • If a nursing leadership on a unit declines survey participation for their unit, nurses who work on that unit will not be recruited/included.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Measuring and Reducing Substance Use Disorder Stigma Among Hospital-based Nurses

The purpose is to measure substance use disorder (SUD)-related stigma among hospital-based nurses using validated survey instruments, and attempt to reduce stigma through a combination of individual and unit-based educational and participatory interventions.

Read the detailed description

The proposed research is a pre-/post-survey, qualitative study of substance use disorder-related stigma among nurses and a sustained, "bundled" intervention to reduce this stigma. The objectives of the study are to:

  1. Measure existing substance use disorder (SUD) stigma among nurses at HUP;
  2. Evaluate the effects of combined individual and unit-based stigma-reduction interventions; and
  3. Adapt and psychometrically analyze a stigma assessment instrument tailored to hospital-based health care providers.

The study team will approach unit-based nursing leadership on target units regarding participation in the (1) unit-based education/awareness activities and (2) individual-based survey and randomized intervention. The study team may meet virtually with unit-based nursing leadership, and/or present the intervention and survey opportunity during unit council meetings per the request of leadership. The study team will send an email to the complete unit nursing listserv. The email from the study team will contain information about the study, contact information, and consent form. Once the ICF has been electronically signed by a participant, the Way to Health platform will generate and send an electronic message to the participant containing a link to the survey.

After 6-months , nurses who completed the ICF \& pre-survey previously will receive electronic prompts from Way to Health to complete the post-survey. The survey will first be made available to pre-survey completers. After 2 weeks, the survey opportunity will be opened to non-enrolled nurses on the participating unit; this will be communicated to the participating unit by the study team via an email to the nursing listserv, which will includeThe email from the study team will contain information about the study, contact information, and consent form. The ICF must be electronically signed by a participant in order for the survey to become available.

Interventions:

  1. Unit-based "Person First" Anti-stigma Awareness Rounds The "Person First" Initiative was developed independent of this study by bedside nurses in collaboration with HUP Nursing Executive Leadership. The objective of this initiative is to provide (1) unit-based "huddles" on person-first language as a mechanism to reduce the stigma around substance use; (2) socialize best practices and resources for patients with substance use disorder; and (3) provide overdose reversal training and kits, including Narcan nasal spray, to nurses. The planning and implementation of these activities fall under the purview of Nursing Shared Governance (NOT the research team), and oversight for these activities will be provided by HUP Nursing Executive Leadership (Chief Nursing Executive Colleen Mattioni and Director of Ethics Aliza Narva). The goal of the "Person First" initiative is to engage with every unit at HUP, although level of engagement (e.g. single round vs multiple rounds) will vary by unit capacity and interest, and some units may opt out of these activities.
  2. Individual Text-based Messaging Participating nurses will be randomized to (1) receive short text messages that employ evidence-based strategies to reduce stigma towards individuals with substance use disorder, or (2) no messaging. Pre-determined messages will be sent via Way to Health weekly for 6 months to the phone number provided by participants during the consent process. Participants will have the option to stop receiving these messages at any time.
Being tested
Unit-based "Person First" Anti-stigma Awareness Rounds, Individual Text-based Messaging
Medical subject headings
Substance-Related Disorders, Social Stigma

What participants receive

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

  • Unit-based "Person First" Anti-stigma Awareness RoundsOther

    Educational rounds on stigma

  • Individual Text-based MessagingOther

    Weekly evidence based messages to reduce SUD stigma

Study groups in NCT05218681
Study groupRoleWhat they receive
Control: Unit-based "Person First" Anti-stigma Awareness RoundsOtherThe "Person First" Initiative was developed independent of this study by bedside nurses (including McFadden) in collaboration with HUP Nursing Executive Leadership. The objective of this initiative is to provide (1) unit-based "huddles" on person-first language as a mechanism to reduce the stigma around substance use; (2) socialize best practices and resources for patients with substance use disorder; and (3) provide overdose reversal training and kits, including Narcan nasal spray, to nurses. The planning and implementation of these activities fall under the purview of Nursing Shared Governance (NOT the research team), and oversight for these activities will be provided by HUP Nursing Executive Leadership.
Receives: Other: Unit-based "Person First" Anti-stigma Awareness Rounds
Unit-based "Person First" stigma rounds + Text-based MessagingOtherParticipating nurses will be randomized to receive weekly short text messages that employ evidence-based strategies to reduce stigma towards individuals with substance use disorder over the course of 6-months.
Receives: Other: Unit-based "Person First" Anti-stigma Awareness Rounds; Other: Individual Text-based Messaging

What is being measured

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

  1. Change in stigma towards patients with Substance use disorder on the individual nursing level

    Change in stigma towards patients with substance use disorder based on pre-post survey among individual nurses. Nurses will be given the same survey pre and post-intervention. The survey includes a Modified stigma score where likert scales are dichotomized as follows:

    • Very Approriate, Appropriate vs Other
    • Strongly agree and agree vs other

    Measured: 6-months

Secondary outcomes (1)
  1. Change in stigma on the unit-level

    Change in stigma towards patients with substance use disorder based on pre-post survey across units. Nurses will be given the same survey pre and post-intervention. The survey includes a Modified stigma score where likert scales are dichotomized as follows:

    • Very Approriate, Appropriate vs Other
    • Strongly agree and agree vs other

    Measured: 6-months

Timeline

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

  1. First posted1 Feb 2022
  2. Study start17 Nov 2021
  3. Primary completion8 Aug 2022
  4. Study completion8 Aug 2022

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05218681
Sponsor's protocol ID
849369
Status last verified
Sep 2022
First submitted
15 Nov 2021
Last updated
9 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Unit-based "Person First" Anti-stigma Awareness Rounds and Individual Text-based Messaging in people with Substance Use Disorders and Stigma, Social, run by University of Pennsylvania 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: finished, as of the sponsor's last update on 9 Sep 2022. 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?

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?

Change in stigma towards patients with Substance use disorder on the individual nursing level (time frame: 6-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 9 Sep 2022.

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