Diabetes Mellitus, Type 2SBIRT-PCNCT01966432

Screening, Brief Intervention, and Referral to Treatment in Primary Care

A study testing Referral to Treatment and Brief Intervention in people with Diabetes Mellitus, Type 2 and Substance-related Disorders, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2, Substance-related Disorders
What is being tested?: Referral to Treatment and Brief Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 134 participants
Where: 1 siteUnited States
Study dates: Aug 2013to Jun 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Adults ≥ 18 years
Diagnosis of Type 2 diabetes
Reside in Durham County, NC, or the neighboring areas and receive the majority of their healthcare in the county
Referral from the primary care clinician or patient's medical home if one has been designated
Have capacity to make decisions

Who cannot join

Lack capacity to make decisions and do not have a surrogate with authority to make health care decisions.
Have a terminal illness with a life expectancy of 6 months or less
Diagnosis of Type 1 diabetes or gestational diabetes
Currently pregnant
Unable to comply with study requirement

Trial locations and contacts

1 site in 1 country.

United States1 site

Durham County Department of Public Health
Durham, North Carolina, 27701

Other trials in United States

About this study

Official title: Screening, Brief Intervention, and Referral to Treatment in Primary Care (SBIRT-PC): An add-on Project to "Duke University Southeastern Diabetes Initiative"

This add-on study of providing tobacco, alcohol and other drug screening, brief intervention and referral for treatment to a primary care high risk diabetic population leverages the existing research resources of a funded parent project "Duke University CMS Innovation Award Southeastern Diabetes initiative (PI: Robert M. Califf, MD)" to explore the feasibility of implementing Screening for substance use, Brief Intervention, and Referral to Treatment services in Primary Care (SBIRT-PC) and to examine the effects of substance use status on diabetes health care outcomes. This pilot study also examines the feasibility of the CTN's common data element algorithms of SBIRT for illicit and nonmedical drug use in the primary care setting.

Read the detailed description

Duke University Translational Medicine Institute has received funds from the Bristol-Myers Squibb Foundation and the Centers for Medicare and Medicaid Services (2012-2016) to augment existing standard of care for patients with diabetes in community-based medical settings in order to achieve goals of better health, better health care, and reduced costs ("Duke University CMS Innovation Award Southeastern Diabetes initiative"; Principal Investigator, Robert M. Califf, MD). Its goals are to (1) improve population-level diabetes management, health outcomes, and quality of life for diagnosed and undiagnosed adults living with type 2 diabetes, (2) reduce disparities in diabetes management, health outcomes and quality of life for adults living with type 2 diabetes, and (3) reduce healthcare costs associated with type 2 diabetes. This already funded diabetes care project provides a cost-effective platform for conducting an add-on project to examine the feasibility of the CTN's clinical decision support algorithms for SBIRT in primary care settings, as the study team can leverage existing organizational and research infrastructure to facilitate the completion of the study. The add-on study is supported by strong rationale, including the fact that primary care settings serve as common points of contact for adults and provide many opportunities to detect drug misuse and to intervene early in low or mild severity (better outcomes), which in turn may reduce substance use, increase awareness and drug-medication interactions, enhance patient medication adherence, and decrease high inpatient costs and repeat emergency department visits.

Conditions: Diabetes Mellitus, Type 2, Substance-related Disorders
Being tested: Referral to Treatment, Brief Intervention
Keywords: Substance abuse, Alcohol use, Tobacco use, Brief intervention, Referral to treatment
Medical subject headings: Diabetes Mellitus, Type 2, Substance-Related Disorders, Alcohol Drinking, Tobacco Use

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Referral to TreatmentBehavioural
Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.
Brief InterventionBehavioural
Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits.

Study groups in NCT01966432
Study group	Role	What they receive
SBIRT	Other	This is a single arm, non-randomized study. However, based on participants' substance use status, participants will be categorized into three groups: 1. Screening group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits. 2. Screening, Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use. 3. Screening, Brief Intervention, and Referral to Treatment group. Patients who screen positive for use and have a positive AUDIT-C and/or positive DAST-10 assessment for problematic alcohol or drug use. Receives: Behavioral: Referral to Treatment; Behavioral: Brief Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Drug Use Status and Frequency
Results of DAST-10 survey to determine use of illicit or nonmedical drugs.The Drug Abuse Screening Test (DAST-10) is a 10-item brief screening tool that assesses drug use, not including alcohol or tobacco use, in the past 12 months. Each question requires a yes or no response, and the tool can be completed in less than 8 minutes. DAST-10 scores on a 10-point scale. A score of 0 indicates no problems and 10 indicates a severe level of problems are associated with drug abuse.
Measured: Baseline, Six Month Follow-up
Cigarette Smoking Status and Nicotine Dependence
Results from Fagerstrom Test for Nicotine Dependence. The Fagerström Test for Nicotine Dependence is a standard instrument for assessing the intensity of physical addiction to nicotine. It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine.
Measured: Baseline, Six Month Follow-up
Alcohol Use Status
Results of AUDIT-C survey. The AUDIT-C is a 3-item alcohol screen that can help identify people who are hazardous drinkers or have active alcohol use disorders. AUDIT-C is scored on a scale of 0-12. The higher the score, the more likely it is that the person's drinking is affecting his/her safety
Measured: Baseline, Six Month Follow-up
Percentage of Participants Who Reported Substance Use at 6 Month
For SBI and SBIRT groups: Proportion of baseline substance users (SBI, SBIRT) who continue substance use during the study (self reported) For S group: Proportion of baseline non-users (S) who report substance use during follow-up visit
Measured: Baseline, Six Month Follow-up
Treatment for Drug Use or Alcohol
Percentage of patients who received substance abuse or alcohol treatment (self reported)
Measured: Baseline, Six Month Follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2013Jun 2016

First posted21 Oct 2013 (estimated)
Study startAug 2013
Primary completionJun 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
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: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Model description: This is a single group, non-randomized, pilot study that explores the feasibility of applying SBIRT to adult with high-risk diabetes.
Masking: None (open label)
Enrolment: 134 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01966432
Sponsor's protocol ID: Pro00043463_1
Other IDs: 2U10DA013727, CTN-0057 OT, 3UG1DA040317
Acronym: SBIRT-PC
Status last verified: Jun 2017
First submitted: 17 Oct 2013
Last updated: 3 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Wu LT, Brady KT, Spratt SE, Dunham AA, Heidenfelder B, Batch BC, Lindblad R, VanVeldhuisen P, Rusincovitch SA, Killeen TK, Ghitza UE. Using electronic health record data for substance use Screening, Brief Intervention, and Referral to Treatment among adults with type 2 diabetes: Design of a National Drug Abuse Treatment Clinical Trials Network study. Contemp Clin Trials. 2016 Jan;46:30-38. doi: 10.1016/j.cct.2015.11.009. Epub 2015 Nov 10.
PubMed 26563446
Wu LT, Ghitza UE, Batch BC, Pencina MJ, Rojas LF, Goldstein BA, Schibler T, Dunham AA, Rusincovitch S, Brady KT. Substance use and mental diagnoses among adults with and without type 2 diabetes: Results from electronic health records data. Drug Alcohol Depend. 2015 Nov 1;156:162-169. doi: 10.1016/j.drugalcdep.2015.09.003. Epub 2015 Sep 12.
PubMed 26392231
Wu LT, Ghitza UE, Zhu H, Spratt S, Swartz M, Mannelli P. Substance use disorders and medical comorbidities among high-need, high-risk patients with diabetes. Drug Alcohol Depend. 2018 May 1;186:86-93. doi: 10.1016/j.drugalcdep.2018.01.008. Epub 2018 Mar 3.
PubMed 29554592

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Screening, Brief Intervention, and Referral to Treatment in Primary Care (SBIRT-PC): An add-on Project to "Duke University Southeastern Diabetes Initiative"
ClinicalTrials.gov ID: NCT01966432
Acronym / sponsor ID: SBIRT-PC / Pro00043463_1
Conditions: Diabetes Mellitus, Type 2, Substance-related Disorders
Keywords: Substance abuse, Alcohol use, Tobacco use, Brief intervention, Referral to treatment
Study type: Interventional
Recruitment status: Completed
Enrolment: 134 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Aug 2013 (actual)
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 21 Oct 2013 (estimated)
Results: Posted 26 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This is a single group, non-randomized, pilot study that explores the feasibility of applying SBIRT to adult with high-risk diabetes.

Arm	Type	Receives
SBIRT	Other	Behavioral: Referral to Treatment, Behavioral: Brief InterventionThis is a single arm, non-randomized study. However, based on participants' substance use status, participants will be categorized into three groups: 1. Screening group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits. 2. Screening, Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use. 3. Screening, Brief Intervention, and Referral to Treatment group. Patients who screen positive for use and have a positive AUDIT-C and/or positive DAST-10 assessment for problematic alcohol or drug use.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Adults ≥ 18 years
Diagnosis of Type 2 diabetes
Reside in Durham County, NC, or the neighboring areas and receive the majority of their healthcare in the county
Referral from the primary care clinician or patient's medical home if one has been designated
Have capacity to make decisions

Key exclusion criteria (5 listed)

Lack capacity to make decisions and do not have a surrogate with authority to make health care decisions.
Have a terminal illness with a life expectancy of 6 months or less
Diagnosis of Type 1 diabetes or gestational diabetes
Currently pregnant
Unable to comply with study requirement

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
Referral to TreatmentPatients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.	Behavioural	SBIRT
Brief InterventionPatients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits.	Behavioural	SBIRT

Primary outcome

Drug Use Status and Frequency
Time frame: Baseline, Six Month Follow-up
Results of DAST-10 survey to determine use of illicit or nonmedical drugs.The Drug Abuse Screening Test (DAST-10) is a 10-item brief screening tool that assesses drug use, not including alcohol or tobacco use, in the past 12 months. Each question requires a yes or no response, and the tool can be completed in less than 8 minutes. DAST-10 scores on a 10-point scale. A score of 0 indicates no problems and 10 indicates a severe level of problems are associated with drug abuse.
Cigarette Smoking Status and Nicotine Dependence
Time frame: Baseline, Six Month Follow-up
Results from Fagerstrom Test for Nicotine Dependence. The Fagerström Test for Nicotine Dependence is a standard instrument for assessing the intensity of physical addiction to nicotine. It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine.
Alcohol Use Status
Time frame: Baseline, Six Month Follow-up
Results of AUDIT-C survey. The AUDIT-C is a 3-item alcohol screen that can help identify people who are hazardous drinkers or have active alcohol use disorders. AUDIT-C is scored on a scale of 0-12. The higher the score, the more likely it is that the person's drinking is affecting his/her safety
Percentage of Participants Who Reported Substance Use at 6 Month
Time frame: Baseline, Six Month Follow-up
For SBI and SBIRT groups: Proportion of baseline substance users (SBI, SBIRT) who continue substance use during the study (self reported) For S group: Proportion of baseline non-users (S) who report substance use during follow-up visit
Treatment for Drug Use or Alcohol
Time frame: Baseline, Six Month Follow-up
Percentage of patients who received substance abuse or alcohol treatment (self reported)

Results and safety

Results posted to the registry on 26 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SBIRT Group	10	5
SBI Group	34	21
S Group	54	28

Primary outcome: Drug Use Status and Frequency

Time frame: Baseline, Six Month Follow-up. Mean (95% Confidence Interval). Unit: units on a scale

Measure	SBIRT Group n = 10	SBI Group n = 34	S Group n = 54
Baseline	2.00 (0.57 to 3.43)	0.03 (0.00 to 0.09)	0.02 (0.00 to 0.06)
Followup	0.60 (0.00 to 1.71)	0.00 (0.00 to 0.00)	0.00 (0.00 to 0.00)

Population analysed: All subjects who completed the assessments were included.

Primary outcome: Cigarette Smoking Status and Nicotine Dependence

Time frame: Baseline, Six Month Follow-up. Mean (95% Confidence Interval). Unit: units on a scale

Measure	SBIRT Group n = 10	SBI Group n = 34	S Group n = 54
Baseline	1.50 (0.02 to 2.98)	2.91 (2.01 to 3.81)	0.00 (0.00 to 0.00)
Follow-up	1.60 (0.00 to 4.84)	2.78 (1.71 to 3.85)	0.00 (0.00 to 0.00)

Population analysed: All subjects who completed the assessments were included.

Primary outcome: Alcohol Use Status

Time frame: Baseline, Six Month Follow-up. Mean (95% Confidence Interval). Unit: units on a scale

Measure	SBIRT Group n = 10	SBI Group n = 34	S Group n = 54
Baseline	1.60 (0.00 to 4.06)	0.76 (0.37 to 1.16)	0.00 (0.00 to 0.00)
Follow-up	0.00 (0.00 to 0.00)	0.44 (0.00 to 0.90)	0.00 (0.00 to 0.00)

Population analysed: All subjects who completed the assessments were included.

Primary outcome: Percentage of Participants Who Reported Substance Use at 6 Month

Time frame: Baseline, Six Month Follow-up. Number (95% Confidence Interval). Unit: percentage of participants

Measure	SBIRT Group n = 10	SBI Group n = 34	S Group n = 54
Baseline	30.0 (10.8 to 60.3)	0.0 (0.0 to 0.0)	0.0 (0.0 to 0.0)
Followup	0.0 (0.0 to 0.0)	0.0 (0.0 to 0.0)	0.0 (0.0 to 0.0)

Population analysed: All subjects who completed the assessments were included.

Adverse events

Time frame: Adverse Event data collected at baseline interview.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SBIRT Group	0 of 10 (0%)	0 of 10 (0%)	0 of 10
SBI Group	0 of 34 (0%)	0 of 34 (0%)	0 of 34
S Group	0 of 54 (0%)	0 of 54 (0%)	0 of 54

Limitations and caveats (from the sponsor): This pilot study is not randomized, and it is not designed for hypothesis testing. Any conclusions arising from these data must be regarded as exploratory and preliminary, and need to be validated by independent data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26563446Wu LT, Brady KT, Spratt SE, Dunham AA, Heidenfelder B, Batch BC, Lindblad R, VanVeldhuisen P, Rusincovitch SA, Killeen TK, Ghitza UE. Using electronic health record data for substance use Screening, Brief Intervention, and Referral to Treatment among adults with type 2 diabetes: Design of a National Drug Abuse Treatment Clinical Trials Network study. Contemp Clin Trials. 2016 Jan;46:30-38. doi: 10.1016/j.cct.2015.11.009. Epub 2015 Nov 10.
Results publication: PubMed 26392231Wu LT, Ghitza UE, Batch BC, Pencina MJ, Rojas LF, Goldstein BA, Schibler T, Dunham AA, Rusincovitch S, Brady KT. Substance use and mental diagnoses among adults with and without type 2 diabetes: Results from electronic health records data. Drug Alcohol Depend. 2015 Nov 1;156:162-169. doi: 10.1016/j.drugalcdep.2015.09.003. Epub 2015 Sep 12.
Results publication: PubMed 29554592Wu LT, Ghitza UE, Zhu H, Spratt S, Swartz M, Mannelli P. Substance use disorders and medical comorbidities among high-need, high-risk patients with diabetes. Drug Alcohol Depend. 2018 May 1;186:86-93. doi: 10.1016/j.drugalcdep.2018.01.008. Epub 2018 Mar 3.

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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.

Li-Tzy Wu, RN, ScD principal investigator

Duke University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Referral to Treatment and Brief Intervention in people with Diabetes Mellitus, Type 2 and Substance-related Disorders, run by Duke 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 5 inclusion and 5 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 3 Jul 2018. 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?

Yes. Results are posted in the registry (first posted 26 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Drug Use Status and Frequency (time frame: Baseline, Six Month Follow-up). The study lists 5 primary outcomes in all. 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 NCT01966432, which also lists 3 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 3 Jul 2018.