Screening, Brief Intervention, and Referral to Treatment in Primary Care (SBIRT-PC)

Duke University

Status: Completed

Conditions: Substance-related Disorders; Diabetes Mellitus, Type 2

Treatments: Behavioral: Brief Intervention; Behavioral: Referral to Treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01966432

3UG1DA040317 (U.S. NIH Grant/Contract)

CTN-0057 OT (Other Grant/Funding Number)

Pro00043463_1

2U10DA013727 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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134 participants in 1 patient group

SBIRT

Other group

Description:

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.

Treatment:

Behavioral: Brief Intervention

Behavioral: Referral to Treatment