Screening, Brief Intervention, and Referral to Treatment in Primary Care (SBIRT-PC)
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|ClinicalTrials.gov Identifier: NCT01966432|
Recruitment Status : Completed
First Posted : October 21, 2013
Results First Posted : July 26, 2017
Last Update Posted : July 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2 Substance-related Disorders||Behavioral: Referral to Treatment Behavioral: Brief Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||134 participants|
|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)|
|Official Title:||Screening, Brief Intervention, and Referral to Treatment in Primary Care (SBIRT-PC): An add-on Project to "Duke University Southeastern Diabetes Initiative"|
|Actual Study Start Date :||August 2013|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
This is a single arm, non-randomized study. However, based on participants' substance use status, participants will be categorized into three groups:
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.
- 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)
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
|United States, North Carolina|
|Durham County Department of Public Health|
|Durham, North Carolina, United States, 27701|
|Principal Investigator:||Li-Tzy Wu, RN, ScD||Duke University|