Clinical trial NCT01966432: Screening, Brief Intervention, and Referral to Treatment in Primary Care
Official title: Screening, Brief Intervention, and Referral to Treatment in Primary Care (SBIRT-PC): An add-on Project to "Duke University Southeastern Diabetes Initiative"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Substance-related Disorders
Keywords: Substance abuse
Alcohol use
Tobacco use
Brief intervention
Referral to treatment
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2013-10-21
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single group, non-randomized, pilot study that explores the feasibility of applying SBIRT to adult with high-risk diabetes.
Primary purpose: SCREENING

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Drug Use Status and Frequency
timeFrame: Baseline, Six Month Follow-up
measure: Cigarette Smoking Status and Nicotine Dependence
timeFrame: Baseline, Six Month Follow-up
measure: Alcohol Use Status
timeFrame: Baseline, Six Month Follow-up
measure: Percentage of Participants Who Reported Substance Use at 6 Month
timeFrame: Baseline, Six Month Follow-up
measure: Treatment for Drug Use or Alcohol
timeFrame: Baseline, Six Month Follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham County Department of Public Health
state: North Carolina
Study officials:
affiliation: Duke University
name: Li-Tzy Wu, RN, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.