N/A
N=98
Screening, Brief Intervention, and Referral to Treatment in Primary Care
Diabetes Mellitus, Type 2 · Substance-related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01966432 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Drug Use Status and Frequency — 2.00; 0.03; 0.02; 0.60 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Referral to Treatment (Behavioral); Brief Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Drug Use Status and Frequency |
2.00; 0.03; 0.02; 0.60; 0.00; 0.00 | — |
| PRIMARY Cigarette Smoking Status and Nicotine Dependence |
1.50; 2.91; 0.00; 1.60; 2.78; 0.00 | — |
| PRIMARY Alcohol Use Status |
1.60; 0.76; 0.00; 0.00; 0.44; 0.00 | — |
| PRIMARY Percentage of Participants Who Reported Substance Use at 6 Month |
30.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Treatment for Drug Use or Alcohol |
20.0; 0.0; 0.0; 20.0; 0.0; 0.0 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01966432). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.