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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01966432
First Posted: October 21, 2013
Last Update Posted: September 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Duke University
  Purpose
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.

Condition Intervention
Diabetes Mellitus, Type 2 Substance-related Disorders Behavioral: Referral to Treatment Behavioral: Brief Intervention

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Screening
Official Title: Screening, Brief Intervention, and Referral to Treatment in Primary Care (SBIRT-PC): An add-on Project to "Duke University Southeastern Diabetes Initiative"

Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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

  • 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

  • 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)


Enrollment: 134
Actual Study Start Date: August 2013
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
SBIRT

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
Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.
Behavioral: Brief Intervention
Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966432


Locations
United States, North Carolina
Durham County Department of Public Health
Durham, North Carolina, United States, 27701
Sponsors and Collaborators
Duke University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Li-Tzy Wu, RN, ScD Duke University
  More Information

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01966432     History of Changes
Other Study ID Numbers: Pro00043463_1
2U10DA013727 ( U.S. NIH Grant/Contract )
CTN-0057 OT ( Other Grant/Funding Number: National Institute on Drug Abuse )
3UG1DA040317 ( U.S. NIH Grant/Contract )
First Submitted: October 17, 2013
First Posted: October 21, 2013
Results First Submitted: June 2, 2017
Results First Posted: July 26, 2017
Last Update Posted: September 22, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:
Substance abuse
Alcohol use
Tobacco use
Brief intervention
Referral to treatment

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Substance-Related Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Chemically-Induced Disorders
Mental Disorders