Skip to main content
OpenTrials
Completed

NCT Number: NCT01966432

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Alcohol Drinking Behavior Chemically-Induced Disorders Diabetes Mellitus Drinking Behavior Endocrine System Diseases Glucose Metabolism Disorders Mental Disorders Metabolic Diseases Nutritional and Metabolic Diseases Substance-Related Disorders Tobacco Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Durham County Department of Public Health

Durham, North Carolina, 27701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Brief intervention

Behavioral

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

Primary outcomes

  1. Drug Use Status and Frequency

    Time frame: 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.

  2. Cigarette Smoking Status and Nicotine Dependence

    Time frame: 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.

  3. Alcohol Use Status

    Time frame: 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

  4. Percentage of Participants Who Reported Substance Use at 6 Month

    Time frame: 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

  5. Treatment for Drug Use or Alcohol

    Time frame: Baseline, Six Month Follow-up

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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: SBIRT-PC

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 21, 2013
Registry last updated
Jul 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.