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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 2, Substance-related Disorders

Intervention / Treatment
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* Behavioral: Referral to Treatment
* Behavioral: Brief Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SBIRT<br>This is a single arm, non-randomized study. However, based on participants' substance use status, participants will be categorized into three groups: Screening group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits. Screening, Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use. 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<br>* Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.<br>Behavioral: Brief Intervention<br>* Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Substance abuse, Alcohol use, Tobacco use, Brief intervention, Referral to treatment