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.
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
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:
- Measure existing substance use disorder (SUD) stigma among nurses at HUP;
- Evaluate the effects of combined individual and unit-based stigma-reduction interventions; and
- 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:
- 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.
- 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.
- Conditions
- Substance Use Disorders, Stigma, Social
- 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 group | Role | What they receive |
|---|---|---|
| Control: Unit-based "Person First" Anti-stigma Awareness Rounds | Other | The "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 Messaging | Other | Participating 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.
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)
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.
- First posted1 Feb 2022
- Study start17 Nov 2021
- Primary completion8 Aug 2022
- Study completion8 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. Kit Delgado, MD, University of Pennsylvania
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring and Reducing Substance Use Disorder Stigma Among Hospital-based Nurses
- ClinicalTrials.gov ID
- NCT05218681
- Acronym / sponsor ID
- 849369
- Conditions
- Substance Use Disorders, Stigma, Social
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 8 Aug 2022 (actual)
- Study completion
- 8 Aug 2022 (actual)
- First posted
- 1 Feb 2022 (actual)
- 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 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.
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:
- Measure existing substance use disorder (SUD) stigma among nurses at HUP;
- Evaluate the effects of combined individual and unit-based stigma-reduction interventions; and
- 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:
- 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.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control: Unit-based "Person First" Anti-stigma Awareness Rounds | Other | Other: Unit-based "Person First" Anti-stigma Awareness RoundsThe "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. |
| Unit-based "Person First" stigma rounds + Text-based Messaging | Other | Other: Unit-based "Person First" Anti-stigma Awareness Rounds, Other: Individual Text-based MessagingParticipating 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Registered nurses working in any capacity (bedside, administration) at the Hospital of the University of Pennsylvania.
Key exclusion criteria (1 listed)
- If a nursing leadership on a unit declines survey participation for their unit, nurses who work on that unit will not be recruited/included.
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 |
|---|---|---|
| Unit-based "Person First" Anti-stigma Awareness RoundsEducational rounds on stigma | Other | Control: Unit-based "Person First" Anti-stigma Awareness Rounds, Unit-based "Person First" stigma rounds + Text-based Messaging |
| Individual Text-based MessagingWeekly evidence based messages to reduce SUD stigma | Other | Unit-based "Person First" stigma rounds + Text-based Messaging |
Primary outcome
Change in stigma towards patients with Substance use disorder on the individual nursing level
Time frame: 6-months
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
1 secondary outcome
Change in stigma on the unit-level
Time frame: 6-months
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 9 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.