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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Duke University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01966432
First received: October 17, 2013
Last updated: May 6, 2014
Last verified: May 2014
  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: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Screening, Brief Intervention, and Referral to Treatment in Primary Care (SBIRT-PC): An add-on Project to "Duke University Southeastern Diabetes Initiative"

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in drug use status or frequency [ Time Frame: Baseline, 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
    Use of illicit or nonmedical drugs; results of DAST-10 survey

  • Change in treatment use status for drug use problems [ Time Frame: Baseline, 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
  • Change in cigarette smoking status and nicotine dependence [ Time Frame: Baseline, 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
    Includes results from Fagerstrom Test for Nicotine Dependence

  • Change in alcohol use status [ Time Frame: Baseline, 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
    Includes results of AUDIT-C survey

  • Change in treatment use status for alcohol use problems [ Time Frame: Baseline, 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in medication adherence [ Time Frame: Baseline, 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
    Morisky Medication Adherence Survey collected by parent study

  • Rate of healthcare services utilization [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    Emergency department and inpatient hospital visits collected by the parent study

  • Incidence of micro-and macrovascular outcomes [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    Kidney disease, retinopathy, neuropathy, hypertension, heart failure, amputation, and stroke data collected by the parent study

  • Patient-reported global health scale scores [ Time Frame: Baseline, 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
    PROMIS survey data collected by the parent study


Estimated Enrollment: 400
Study Start Date: August 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SBIRT
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.
Experimental: SBI
Screening, Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use.
Behavioral: Brief Intervention
Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits.
No Intervention: S
Screening group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01966432

Contacts
Contact: Brooke Heidenfelder, PhD 919-668-8355 brooke.heidenfelder@duke.edu

Locations
United States, North Carolina
Durham County Department of Public Health Recruiting
Durham, North Carolina, United States, 27701
Principal Investigator: Li-Tzy Wu, ScD         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Li-Tzy Wu, ScD Duke University School of Medicine
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01966432     History of Changes
Other Study ID Numbers: Pro00043463_1, U10DA013727, NIDA-CTN-0057
Study First Received: October 17, 2013
Last Updated: May 6, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

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

ClinicalTrials.gov processed this record on August 01, 2014