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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Substance-related Disorders
• Interventions: Behavioral: Referral to Treatment; Behavioral: Brief Intervention

• Registration Number: NCT01966432
• Lead Sponsor: Duke University

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-10-17
• Study First Submitted QC: 2013-10-17
• Study First Posted: 2013-10-21
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-06
• Results First Submitted: 2017-06-02
• Results First Submitted QC: 2017-06-02
• Results First Posted: 2017-07-26
• Last Update Submitted: 2018-06-05
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SBIRT	Brief Intervention	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.
SBIRT	Referral to Treatment	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.

Primary Outcome Measures

Name	Time	Method
Drug Use Status and Frequency	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	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	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	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	Baseline, Six Month Follow-up	Percentage of patients who received substance abuse or alcohol treatment (self reported)

Trial Locations

Locations (1)

Durham County Department of Public Health; 🇺🇸 Durham, North Carolina, United States