Implementation and Evaluation of SBIRT

NCT ID: NCT03560076

Last Updated: 2020-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2562 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-07-31

Brief Summary

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Alarming rates of unhealthy alcohol, non-prescription drug, and tobacco use highlight the preventable health risks of substance abuse and the urgent need to advance behavioral health systems. Screening, Brief Intervention, and Referral to Treatment (SBIRT) is an efficacious and effective strategy for the delivery of early intervention and treatment services for people with substance use disorders as well as for those who are at-risk for developing these disorders. A mixed methods phased cluster randomized approach is used to evaluate SBIRT implementation in one medical surgical unit from each of 14 hospitals to inform SBIRT implementation methods for rural, community and urban settings in Indiana. The long-term objective is to develop an SBIRT toolkit to disseminate and sustain SBIRT use to increase the screening of substance use, delivery of brief interventions, and referral to treatment services. A broader dissemination will follow based on results of this study.

Detailed Description

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Aim 1: Test if implementation of SBIRT improves processes of care for hospital inpatients currently using tobacco, alcohol or non-prescription drugs.

Aim 2: Estimate the cost of SBIRT implementation and delivery for the health system.

Design and Sample:

A phased cluster randomized mixed methods design using a wait-list usual care control on one medical surgical unit in 14 hospitals will be conducted. The intervention is an SBIRT toolkit.

Each hospital within the healthcare system is eligible to participate, and has agreed to participate (N=14). A computer generated allocation based on a stratified random sampling approach using SPSS was used to randomize hospitals into an intervention (Group 1, n=7) or wait-list usual care control (Group 2, n=7) group. Prior to randomization, hospitals were stratified by type (academic health center, community hospital, or critical access hospital). Allocation to the intervention or wait-list usual care control groups is based on cluster, and participants will be aware of their cluster allocation. One medical surgical unit within each hospital will be selected by the nurse executive to participate. All hospitals will receive the intervention. Group 1 (n=7) hospitals will participate in the implementation and intervention first, with Group 2 (n=7) following six months later.

Methods:

Smoking cessation practices will be collected from nurses (N=560) at baseline. SBIRT use will be collected from nurses on randomly selected days via survey. Observations of SBIRT use and interviews with study coordinators will also be conducted.

SBIRT process delivery for patients will be assessed through review of de-identified electronic medical records (EMRs) abstracted at three time points: baseline, six-months post and 12 months using a random sample of 61 patient EMRs from the participating hospital units at each time point (N=2,562). Data abstracted is retrospective, and consists of SBIRT process elements only.

This study protocol incorporates standardized education on using SBIRT through a train-the-trainer approach. Site coordinators will receive information about the nurse survey and secondary data abstraction procedures. Each group will receive training on the SBIRT intervention (Group 1 first, then Group 2 six months later). Training for site coordinators will include skills in how to teach SBIRT to others and systems strategies for promoting SBIRT uptake. After the site coordinator training is completed, each hospital (via the site coordinator) will train additional nurses, validate skills in SBIRT and develop a referral process specific to its needs.

Conditions

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Substance Use Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Group 1

One medical surgical unit in seven acute care facilities in which nurses have received SBIRT training and implementation strategies and are randomized to Group 1 implementation

SBIRT Training and Implementation Strategies

Intervention Type OTHER

A train-the-trainer approach will be used to train site coordinators on the SBIRT process and implementation strategies.

Group 2

One medical surgical unit in seven acute care facilities in which nurses have received SBIRT training and implementation strategies and are randomized to Group 2 (delayed) implementation

SBIRT Training and Implementation Strategies

Intervention Type OTHER

A train-the-trainer approach will be used to train site coordinators on the SBIRT process and implementation strategies.

Interventions

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SBIRT Training and Implementation Strategies

A train-the-trainer approach will be used to train site coordinators on the SBIRT process and implementation strategies.

Intervention Type OTHER

Other Intervention Names

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Implementation toolkit

Eligibility Criteria

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Inclusion Criteria

a. Medical surgical unit designated as study unit


a. Nurses employed on study unit


1. Age 18 or older admitted to study unit
2. Records randomly selected from each units

Exclusion Criteria

1. Medical surgical unit not designated as study unit
2. Units that do not admit medical surgical patients
2. Nurses


a. Nurses not employed on study unit
3. Patient Electronic Medical Records (EMRs)


1. Age younger than 18 admitted to study unit
2. EMRs of patients admitted to units other than the study unit
3. EMRs of patients admitted to the study unit that are not randomly selected
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Robin P. Newhouse

Dean and Distinguished Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robin P Newhouse, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

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Indiana University

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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Newhouse R, Janney M, Gilbert A, Agley J, Bakoyannis G, Ferren M, Mullins CD, Johantgen M, Schwindt R, Thoele K. Study protocol testing toolkit versus usual care for implementation of screening, brief intervention, referral to treatment in hospitals: a phased cluster randomized approach. Addict Sci Clin Pract. 2018 Dec 27;13(1):28. doi: 10.1186/s13722-018-0130-4.

Reference Type BACKGROUND
PMID: 30587235 (View on PubMed)

Newhouse R, Agley J, Bakoyannis G, Ferren M, Mullins CD, Keen A, Parker E. Effects of a structured SBIRT training program for hospital nursing leaders on utilization of SBIRT within their medical-surgical units: cohort study. BMC Nurs. 2025 Apr 23;24(1):450. doi: 10.1186/s12912-025-03079-9.

Reference Type DERIVED
PMID: 40269928 (View on PubMed)

Other Identifiers

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1801646970

Identifier Type: -

Identifier Source: org_study_id

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