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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05218681
Other study ID # 849369
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 17, 2021
Est. completion date August 8, 2022

Study information

Verified date September 2022
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 170
Est. completion date August 8, 2022
Est. primary completion date August 8, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Registered nurses working in any capacity (bedside, administration) at the Hospital of the University of Pennsylvania. Exclusion Criteria: - If a nursing leadership on a unit declines survey participation for their unit, nurses who work on that unit will not be recruited/included.

Study Design


Intervention

Other:
Unit-based "Person First" Anti-stigma Awareness Rounds
Educational rounds on stigma
Individual Text-based Messaging
Weekly evidence based messages to reduce SUD stigma

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
6-months
Secondary 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
6-months
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