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

NCT01966432 | Completed Results DMC

• 4 other identifiers: Pro00043463_12U10DA013727CTN-0057 OT3UG1DA040317
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Substance-related Disorders

Keywords

Substance abuse; Alcohol use; Tobacco use; Brief intervention; Referral to treatment

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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

  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

  Baseline, Six Month Follow-up

• Treatment for Drug Use or Alcohol

  Percentage of patients who received substance abuse or alcohol treatment (self reported)

  Baseline, Six Month Follow-up

Study Arms (1)

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.

Behavioral: Referral to Treatment; Behavioral: Brief Intervention

Interventions

Referral to Treatment BEHAVIORAL

Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.

SBIRT

Brief Intervention BEHAVIORAL

Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits.

SBIRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Durham County Department of Public Health

Durham, North Carolina, 27701, United States

Location

Related Publications (3)

• 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.

  PMID: 26563446 BACKGROUND

• 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.

  PMID: 26392231 RESULT

• 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.

  PMID: 29554592 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Substance-Related Disorders; Alcohol Drinking; Tobacco Use

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Chemically-Induced Disorders; Mental Disorders; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Li-Tzy Wu, Professor in Psychiatry
• Organization: Duke University, Dept. of Psychiatry and Behavioral Sciences

litzy.wu@duke.edu

(919) 889-9369

Study Officials

• Li-Tzy Wu, RN, ScD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single group, non-randomized, pilot study that explores the feasibility of applying SBIRT to adult with high-risk diabetes.

Study Record Dates

• First Submitted: October 17, 2013
• First Posted: October 21, 2013
• Study Start: August 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 3, 2018
• Results First Posted: July 26, 2017

Record last verified: 2017-06

Locations

US (1)