Screening, Brief Intervention, and Referral to Treatment in Primary Care

Screening, Brief Intervention, and Referral to Treatment in Primary Care (SBIRT-PC): An add-on Project to Duke University Southeastern Diabetes Initiative

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01966432

Acronym

SBIRT-PC

Enrollment

134

Registered

2013-10-21

Start date

2013-08-31

Completion date

2016-06-30

Last updated

2018-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Substance-related Disorders

Keywords

Substance abuse, Alcohol use, Tobacco use, Brief intervention, Referral to treatment

Brief 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.

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.

Interventions

BEHAVIORALReferral 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.

BEHAVIORALBrief Intervention

Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Cigarette Smoking Status and Nicotine Dependence	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	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
Drug Use Status and Frequency	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.
Percentage of Participants Who Reported Substance Use at 6 Month	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	Baseline, Six Month Follow-up	Percentage of patients who received substance abuse or alcohol treatment (self reported)

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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).

Participants by arm

Arm	Count
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.	10
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.	34
S Group Screening only group. Patients who screen for no use of cigarettes, alcohol, or other drugs. Patients are re-screened at followup visits.	54
Total	98

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Lost to Follow-up	3	2	5
Overall Study	SBIRT program ended	1	8	20
Overall Study	Subject Incarcerated	0	0	1
Overall Study	Withdrawal by Subject	1	3	0

Baseline characteristics

Characteristic	SBIRT Group	SBI Group	S Group	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	1 Participants	17 Participants	18 Participants
Age, Categorical Between 18 and 65 years	10 Participants	33 Participants	37 Participants	80 Participants
Age, Continuous	51 years STANDARD_DEVIATION 5.8	51 years STANDARD_DEVIATION 9.1	60 years STANDARD_DEVIATION 12	56 years STANDARD_DEVIATION 11
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants	2 Participants	1 Participants	4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants	31 Participants	53 Participants	93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Black or African American	8 Participants	28 Participants	44 Participants	80 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	2 Participants	4 Participants	7 Participants
Race (NIH/OMB) White	1 Participants	4 Participants	5 Participants	10 Participants
Region of Enrollment United States	10 Participants	34 Participants	54 Participants	98 Participants
Sex: Female, Male Female	7 Participants	14 Participants	33 Participants	54 Participants
Sex: Female, Male Male	3 Participants	20 Participants	21 Participants	44 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 10	0 / 34	0 / 54
other Total, other adverse events	0 / 10	0 / 34	0 / 54
serious Total, serious adverse events	0 / 10	0 / 34	0 / 54

Outcome results

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