Substance Use DisordersNCT03560076
Implementation and Evaluation of SBIRT
An observational study of Substance Use Disorders, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- SBIRT Training and Implementation Strategies
- How many people
- 2,562 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 31 Jul 2019
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Medical surgical unit designated as study unit
- Nurses employed on study unit
- Age 18 or older admitted to study unit
- Records randomly selected from each units
Who cannot join
- Medical surgical unit not designated as study unit
- Units that do not admit medical surgical patients
- Nurses
- Nurses not employed on study unit
- Patient Electronic Medical Records (EMRs)
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phased Multisite Cluster Randomized Trial Testing Screening, Brief Intervention, Referral to Treatment for People That Use Tobacco, Alcohol, and Non-prescription Drugs
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.
Read the detailed description
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
- Substance Use Disorders
- Being tested
- SBIRT Training and Implementation Strategies
- Keywords
- Acute Care, SBIRT, Substance Use, Alcohol, Opioid, Tobacco, Nurse, Toolkit, Implementation
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBIRT Training and Implementation StrategiesOther
Also called Implementation toolkit
A train-the-trainer approach will be used to train site coordinators on the SBIRT process and implementation strategies.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: SBIRT Training and Implementation Strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
SBIRT Process
Differences in screening, brief intervention and referral to treatment between intervention group and wait-list control
Measured: 6 months
Secondary outcomes (2)
Cost of SBIRT implementation
The costs associated with SBIRT implementation and maintenance
Measured: 12 months
SBIRT Process
Changes in screening, brief intervention and referral to treatment within hospitals
Measured: 6 and 12 months post group 1 baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start1 Jan 2018
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,562 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robin P. Newhouse, Indiana University
- Investigators
- Robin P Newhouse, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560076
- Sponsor's protocol ID
- 1801646970
- Status last verified
- May 2020
- First submitted
- 6 Jun 2018
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 30587235Newhouse 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.
PubMed 40269928
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phased Multisite Cluster Randomized Trial Testing Screening, Brief Intervention, Referral to Treatment for People That Use Tobacco, Alcohol, and Non-prescription Drugs
- ClinicalTrials.gov ID
- NCT03560076
- Acronym / sponsor ID
- 1801646970
- Conditions
- Substance Use Disorders
- Keywords
- Acute Care, SBIRT, Substance Use, Alcohol, Opioid, Tobacco, Nurse, Toolkit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,562 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 18 Jun 2018 (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.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: SBIRT Training and Implementation StrategiesOne 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 |
| Group 2 | – | Other: SBIRT Training and Implementation StrategiesOne 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Age 18 or older admitted to study unit
- Records randomly selected from each units
Key exclusion criteria (8 listed)
- Nurses
- Patient Electronic Medical Records (EMRs)
- 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
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 |
|---|---|---|
| SBIRT Training and Implementation StrategiesAlso: Implementation toolkitA train-the-trainer approach will be used to train site coordinators on the SBIRT process and implementation strategies. | Other | Group 1, Group 2 |
Primary outcome
SBIRT Process
Time frame: 6 months
Differences in screening, brief intervention and referral to treatment between intervention group and wait-list control
2 secondary outcomes
Cost of SBIRT implementation
Time frame: 12 months
SBIRT Process
Time frame: 6 and 12 months post group 1 baseline
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 5 May 2020.
- Background: PubMed 30587235Newhouse 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.
- Derived from this study: PubMed 40269928Newhouse 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.
- Individual participant dataSharing planned: No. 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.
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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.
Robin P Newhouse, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Use Disorders, run by Indiana University 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 4 inclusion and 8 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 5 May 2020. 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?
SBIRT Process (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03560076, which also lists 2 linked publications.
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 5 May 2020; AzTrials last refreshed its copy on 29 Oct 2026.