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Implementing Mobile Technology for Unhealthy Alcohol Use

Primary Purpose

Alcohol Drinking

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Implementation Intervention
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alcohol Drinking focused on measuring Implementation Science, Text Messaging, Unhealthy Alcohol Use, Mobile Health, mHealth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Patient Inclusion Criteria

  • Emergency department patient at one of the participating sites
  • 18 years or older
  • English-language fluency
  • Owing a text-capable phone

Staff Inclusion Criteria:

  • Emergency department staff and providers who work in the intervention sites
  • Employed full or part time by the participating health system

Exclusion Criteria: None

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Implementation Intervention

    Implementation as Usual

    Arm Description

    Through virtual and in-person meetings, the internal/external facilitation team will support sites in utilizing the multi-component implementation strategy for 7 months

    In control 'implementation as usual' sites, no facilitation or implementation strategies will be provided. Controls will receive 1) an informational session on the text intervention during grand rounds/staff meetings and 2) flyers to provide patients with intervention enrollment information.

    Outcomes

    Primary Outcome Measures

    Implementation Effectiveness
    The proportion of eligible patients who enroll in the alcohol text messaging intervention

    Secondary Outcome Measures

    Implementation Feasibility using the Feasibility of Intervention Measure (FIM)
    Feasibility of text messaging implementation strategy
    Implementation Acceptability using the Acceptability of Intervention Measure (AIM)
    Acceptability of text messaging implementation strategy

    Full Information

    First Posted
    April 18, 2022
    Last Updated
    September 18, 2023
    Sponsor
    UConn Health
    Collaborators
    Northwell Health, Partnership to End Addiction, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05350878
    Brief Title
    Implementing Mobile Technology for Unhealthy Alcohol Use
    Official Title
    Implementing Mobile Technology for Unhealthy Alcohol Use in Emergency Departments
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    March 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    UConn Health
    Collaborators
    Northwell Health, Partnership to End Addiction, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Scalable approaches are needed to support patients identified in the emergency department as unhealthy alcohol users and text messaging intervention approaches are a promising solution. However, the process of providers making text messing interventions for unhealthy alcohol use available to patients in an efficient way within already busy and overburdened emergency department workflows (i.e., implementation in real-world emergency department settings) and patients adopting them remains a new area of research. Study investigators will examine barriers and facilitators to the adoption of text messaging interventions for unhealthy alcohol use in emergency departments and use a stakeholder-engaged process to develop and test practical implementation strategies that could provide much needed support to patients who screen positive while reducing burden on emergency departments.
    Detailed Description
    Unhealthy alcohol use (UAU) is one of the leading causes of premature mortality among adults in the United States and has been increasing during the COVID-19 pandemic. UAU is more frequent among emergency department (ED) patients than in the general population and ED visits involving alcohol consumption have increased in recent years. Substance use has been described as the most important modifiable health behavior in the ED, and the ED has been highlighted as a key setting to intervene with UAU individuals. Consequently, health systems across the country need low burden, scalable ways to intervene with individuals but often have limited time and resources. Mobile technologies have been suggested as a solution to assist EDs in addressing UAU and one of the lowest burden, scalable approaches are text messaging interventions. Text messaging interventions for ED and trauma patients and other populations have shown good outcomes, including reductions in drinking quantity and frequency. Despite strong research support and promise for scalability, there is little evidence that technology-based behavioral health interventions can be effectively implemented into healthcare settings. There are few studies in which technology interventions for behavioral health are put into real world healthcare settings; those that have been conducted show that the benefits seen in randomized trials are often not realized. While EDs are promising venues for addressing UAU using text messaging interventions, the process of providers making them available to patients in an efficient way within already busy and overburdened ED workflows (i.e., implementation in real-world ED settings) and patients adopting them remains a new area of research. This proposal builds on the longstanding collaboration of our interdisciplinary team on the implementation of substance use screening and brief interventions in healthcare settings. In response to the NIH Notice of Special Interest for Research in the Emergency Setting, the investigators propose to examine potential barriers and facilitators to staff offering and patients accepting a text messaging intervention in the ED. The investigators will then use a stakeholder-engaged Intervention Mapping process to develop a multi-component implementation strategy for EDs. Finally, the investigators will conduct a mixed method 2-arm cluster-randomized pilot study in 4 EDs that serve ~13,000 UAU patients per year to assess the feasibility, acceptability and preliminary effectiveness of the implementation strategy. The Integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework will guide study activities. Low burden technology, like text messaging, along with targeted implementation support and strategies driven by identified barriers and facilitators could sustain large-scale ED-based alcohol screening programs and provide much needed support to patients who screen positive while reducing burden on EDs. The proposed study would be the first to develop and test this targeted implementation strategy. This 2-year R21 will prepare for a future, larger, fully-powered hybrid effectiveness-implementation trial.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Drinking
    Keywords
    Implementation Science, Text Messaging, Unhealthy Alcohol Use, Mobile Health, mHealth

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Parallel Cluster Randomized
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    600 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Implementation Intervention
    Arm Type
    Experimental
    Arm Description
    Through virtual and in-person meetings, the internal/external facilitation team will support sites in utilizing the multi-component implementation strategy for 7 months
    Arm Title
    Implementation as Usual
    Arm Type
    No Intervention
    Arm Description
    In control 'implementation as usual' sites, no facilitation or implementation strategies will be provided. Controls will receive 1) an informational session on the text intervention during grand rounds/staff meetings and 2) flyers to provide patients with intervention enrollment information.
    Intervention Type
    Other
    Intervention Name(s)
    Implementation Intervention
    Intervention Description
    Virtual and in-person implementation support
    Primary Outcome Measure Information:
    Title
    Implementation Effectiveness
    Description
    The proportion of eligible patients who enroll in the alcohol text messaging intervention
    Time Frame
    5-month intervention period
    Secondary Outcome Measure Information:
    Title
    Implementation Feasibility using the Feasibility of Intervention Measure (FIM)
    Description
    Feasibility of text messaging implementation strategy
    Time Frame
    6-months post-intervention
    Title
    Implementation Acceptability using the Acceptability of Intervention Measure (AIM)
    Description
    Acceptability of text messaging implementation strategy
    Time Frame
    6-months post-intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Patient Inclusion Criteria Emergency department patient at one of the participating sites 18 years or older English-language fluency Owing a text-capable phone Staff Inclusion Criteria: Emergency department staff and providers who work in the intervention sites Employed full or part time by the participating health system Exclusion Criteria: None
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Megan A O'Grady, PhD
    Phone
    860-679-5483
    Email
    ogrady@uchc.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Megan A O'Grady, PhD
    Organizational Affiliation
    UConn Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Individual participant data will be shared in the NIAAA Data Archive
    IPD Sharing Time Frame
    Data will be available at the end of the study
    IPD Sharing Access Criteria
    Per NIAAA archive access criteria
    IPD Sharing URL
    https://www.niaaa.nih.gov/research/niaaa-data-archive
    Citations:
    PubMed Identifier
    35933560
    Citation
    O'Grady MA, Kapoor S, Harrison L, Kwon N, Suleiman AO, Muench FJ. Implementing a text-messaging intervention for unhealthy alcohol use in emergency departments: protocol for implementation strategy development and a pilot cluster randomized implementation trial. Implement Sci Commun. 2022 Aug 6;3(1):86. doi: 10.1186/s43058-022-00333-y.
    Results Reference
    derived

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    Implementing Mobile Technology for Unhealthy Alcohol Use

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