Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2U10DA013727 | U.S. NIH Grant/Contract | View source | |
| CTN-0057 OT | Other Grant/Funding Number | National Institute on Drug Abuse | |
| 3UG1DA040317 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBIRT | Other | This is a single arm, non-randomized study. However, based on participants' substance use status, participants will be categorized into three groups:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Drug Use Status and Frequency | 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. | Baseline, Six Month Follow-up |
| Cigarette Smoking Status and Nicotine Dependence | 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. | Baseline, Six Month Follow-up |
| Alcohol Use Status | 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 | Baseline, Six Month Follow-up |
| Percentage of Participants Who Reported Substance Use at 6 Month | 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 | Baseline, Six Month Follow-up |
| Treatment for Drug Use or Alcohol |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Li-Tzy Wu, RN, ScD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham County Department of Public Health | Durham | North Carolina | 27701 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26563446 | Background | Wu LT, Brady KT, Spratt SE, Dunham AA, Heidenfelder B, Batch BC, Lindblad R, VanVeldhuisen P, Rusincovitch SA, Killeen TK, Ghitza UE. Using electronic health record data for substance use Screening, Brief Intervention, and Referral to Treatment among adults with type 2 diabetes: Design of a National Drug Abuse Treatment Clinical Trials Network study. Contemp Clin Trials. 2016 Jan;46:30-38. doi: 10.1016/j.cct.2015.11.009. Epub 2015 Nov 10. | |
| 26392231 | Result |
Not provided
Not provided
The clinical team consented 134 adults (84% of the eligible patients) for the SBIRT study. Of the 134 adults consented (enrolled), 36 are not accounted for in the results section (do not have baseline data).
Based on the results of the baseline substance use screen for the parent Southeastern Diabetes Initiative (SEDI) study at the Durham site, participants were categorized into three groups: Minimal-risk Screen (S) Group; At-risk Screen & Brief Intervention (SBI) Group; and, High-risk Screen, Brief Intervention, & Referral to Treatment (SBIRT) Group.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SBIRT Group | 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. 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. Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits. |
| FG001 | SBI Group | Screening and Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use. Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits. |
| FG002 | S Group | Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SBIRT Group | 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. 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. Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Drug Use Status and Frequency | 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. | All subjects who completed the assessments were included. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, Six Month Follow-up |
|
Adverse Event data collected at baseline interview.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SBIRT Group | 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. 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. Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits. |
Not provided
Not provided
This pilot study is not randomized, and it is not designed for hypothesis testing. Any conclusions arising from these data must be regarded as exploratory and preliminary, and need to be validated by independent data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Li-Tzy Wu, Professor in Psychiatry | Duke University, Dept. of Psychiatry and Behavioral Sciences | (919) 889-9369 | litzy.wu@duke.edu |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D019966 | Substance-Related Disorders |
| D000428 | Alcohol Drinking |
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003419 | Crisis Intervention |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
This is a single group, non-randomized, pilot study that explores the feasibility of applying SBIRT to adult with high-risk diabetes.
Not provided
Not provided
Not provided
Not provided
| Brief Intervention | Behavioral | Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits. |
|
Percentage of patients who received substance abuse or alcohol treatment (self reported) |
| Baseline, Six Month Follow-up |
| Wu LT, Ghitza UE, Batch BC, Pencina MJ, Rojas LF, Goldstein BA, Schibler T, Dunham AA, Rusincovitch S, Brady KT. Substance use and mental diagnoses among adults with and without type 2 diabetes: Results from electronic health records data. Drug Alcohol Depend. 2015 Nov 1;156:162-169. doi: 10.1016/j.drugalcdep.2015.09.003. Epub 2015 Sep 12. |
| 29554592 | Result | Wu LT, Ghitza UE, Zhu H, Spratt S, Swartz M, Mannelli P. Substance use disorders and medical comorbidities among high-need, high-risk patients with diabetes. Drug Alcohol Depend. 2018 May 1;186:86-93. doi: 10.1016/j.drugalcdep.2018.01.008. Epub 2018 Mar 3. |
| Subject Incarcerated |
|
| SBIRT program ended |
|
| BG001 | SBI Group | Screening and Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use. Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits. |
| BG002 | S Group | Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | SBI Group | Screening and Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use. Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits. |
| OG002 | S Group | Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits. |
|
|
| Primary | Cigarette Smoking Status and Nicotine Dependence | 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. | All subjects who completed the assessments were included. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, Six Month Follow-up |
|
|
|
| Primary | Alcohol Use Status | 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 | All subjects who completed the assessments were included. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, Six Month Follow-up |
|
|
|
| Primary | Percentage of Participants Who Reported Substance Use at 6 Month | 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 | All subjects who completed the assessments were included. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Six Month Follow-up |
|
|
|
| Primary | Treatment for Drug Use or Alcohol | Percentage of patients who received substance abuse or alcohol treatment (self reported) | All subjects who completed the assessments were included. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Six Month Follow-up |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | SBI Group | Screening and Brief Intervention group. Patients who screen positive for cigarette, alcohol, or other drug use. Brief Intervention: Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits. | 0 | 34 | 0 | 34 | 0 | 34 |
| EG002 | S Group | Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits. | 0 | 54 | 0 | 54 | 0 | 54 |
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| Follow-up |
|
|
| Follow-up |
|
|
| Followup |
|
|
| Followup |
|
|