NCT03560076

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,562

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

May 5, 2020

Status Verified

May 1, 2020

Enrollment Period

1.6 years

First QC Date

June 6, 2018

Last Update Submit

May 3, 2020

Conditions

Keywords

Acute CareSBIRTSubstance UseAlcoholOpioidTobaccoNurseToolkitImplementation

Outcome Measures

Primary Outcomes (1)

  • SBIRT Process

    Differences in screening, brief intervention and referral to treatment between intervention group and wait-list control

    6 months

Secondary Outcomes (2)

  • Cost of SBIRT implementation

    12 months

  • SBIRT Process

    6 and 12 months post group 1 baseline

Study Arms (2)

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

Other: SBIRT Training 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

Other: SBIRT Training and Implementation Strategies

Interventions

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

Also known as: Implementation toolkit
Group 1Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitals: Hospitals (N=14) within one health system will participate. Group 1 (n=7) hospitals will participate in the implementation first, with Group 2 (n=7) following six months later. Nurses: 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. Patients: SBIRT process data will be abstracted from electronic medical records (EMRs) 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.

You may qualify if:

  • a. Medical surgical unit designated as study unit

You may not qualify if:

  • Medical surgical unit not designated as study unit
  • Units that do not admit medical surgical patients
  • Nurses
  • a. Nurses employed on study unit
  • a. Nurses not employed on study unit
  • Patient Electronic Medical Records (EMRs)
  • Age 18 or older admitted to study unit
  • Records randomly selected from each units
  • Age younger than 18 admitted to study unit
  • EMRs of patients admitted to units other than the study unit
  • EMRs of patients admitted to the study unit that are not randomly selected

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Related Publications (2)

  • 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.

    PMID: 30587235BACKGROUND
  • 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.

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Robin P Newhouse, PhD

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean and Distinguished Professor

Study Record Dates

First Submitted

June 6, 2018

First Posted

June 18, 2018

Study Start

January 1, 2018

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

May 5, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Only SBIRT processes will be abstracted from randomly selected EMRs and will be reported in the aggregate. There is not a plan to share individual participant data. The investigators will share the implementation toolkit publicly.

Locations