Technologically-Augmented Referrals to Mitigate Addiction Consequences

NCT04401215 | Completed DMC

• 2 other identifiers: NIDA-N44DA-16-2246HHSN271201600034C
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The implementation of screening and intervention for substance use disorders, such as Screening Brief Intervention Referral to Treatment (SBIRT), in the primary care setting has faced several challenges. In the past, physicians have cited barriers such as lack of time, lack of access to treatment, and lack of financial resources. To overcome some of the barriers to screening and prevention of substance use disorders, many researchers have begun to explore novel approaches using web-based and mobile technology. While the quality of evidence is often inconsistent, there is promising research to show that interventions utilizing web-based or mobile technology for alcohol and other substance abuse can be effective. Features such as tailored feedback have shown to be more effective than similar programs without feedback, and interventions that combine self-administered therapy in conjunction with therapist-direction interventions show greater reductions in addictive behavior. In this project, the investigators proposed to enhance the Screening Brief Intervention Referral to Treatment (SBIRT) with a digital tool that aims to save physician time and improve patient adherence to treatment goals, through extensive use of shared decision making, patient self-monitoring and goal tracking, and real-time tailored patient feedback and text follow-up for patients. Increase the screening and referral of those patients at risk for substance use disorder (SUD) thereby increasing the number of patients receiving higher level substance use treatment. A total of 500 patients will be screened and randomized into two groups. 250 in the Technology Augmented Treatment group (intervention group) and 250 in the control group. The Washington State University research team, lead by Dr. McPherson, will screen and recruit subjects at CHAS Valley Clinic in Spokane, WA. Subjects in both groups will be followed up for 30 days. At the initial study enrollment visit, the intervention group will be asked questions on an iPad about their eligibility. After the initial visit, subjects in the intervention group will receive up to 4 texts/day on his/her phone that will ask questions about their health after the visit. The control group will be asked questions on an iPad and will be given a call 30 days after to ask questions about their health.

Conditions

Substance Use Disorders

Keywords

Screening Brief Intervention Referral to Treatment (SBIRT).; Technology; Alcohol Use; Substance Use; Tobacco Use

Outcome Measures

Primary Outcomes (1)

• The difference in proportions of participants who receive specialty care in the two arms.

  The investigators estimate that SBIRT intervention (Glass et al 2015) could result in 10% to 30% of patients receiving specialty care. The investigators computed power using the following assumptions: * Control arm with 20% participants receiving specialty care. * Intervention arm with 35% participants receiving specialty care. * Same number of participants in control and intervention. A sample of 197 participants in each of arms will be sufficiently powered to detect such differences between control and intervention arms.

  from baseline visit to day 30 follow up visit.

Secondary Outcomes (1)

• Substance use levels at day 30 between the two arms.

  From baseline visit to day 30 follow up visit.

Study Arms (2)

Technology Augmented Treatment group

OTHER

Intervention Group

Behavioral: Technology Augmented Treatment for Screening, Brief Intervention, Referral, and Treatment (SBIRT)

Control group

NO INTERVENTION

After the baseline visit the control arm participants will receive no additional follow-up beyond usual care until the 30 days' end. Surveys at the end of 30 days.

Interventions

Technology Augmented Treatment for Screening, Brief Intervention, Referral, and Treatment (SBIRT) BEHAVIORAL

This group will answer to questions on the iPad at baseline visit and will receive up to 4 text messages per day asking about their Health and treatment during 30 days.

Also known as: Intervention Group

Technology Augmented Treatment group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be included if they:
• Do not answer "Never'' for TASP1 Q2 or Q3, Q4 \& Q5.
• Age 21 or older.
• Able to read and speak English.
• Able to provide written informed consent.
• Have access to a personal data enabled Mobile device for messaging.

You may not qualify if:

• Participants will be excluded if they meet one or more of the following criteria:
• Answer " "Never" for TAPS1 Q2 or Q3, Q4 \& Q5
• Currently in Substance abuse treatment.
• Have had previous substance use disorder (SUD) diagnosis less than a year ago.
• Were in a psychiatric hospital, or attempted suicide in the last 6 months.
• Have any other medical or psychiatric condition that the PIs determine would compromise safe study participation (e.g., terminal medical condition, recent myocardial infarction).
• Are pregnant.
• In the clinic for urgent conditions.

Sponsors & Collaborators

• Washington State University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

CHAS Valley Clinic

Spokane Valley, Washington, 99216, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Alcohol Drinking; Tobacco Use

Interventions

Mass Screening; Crisis Intervention; Referral and Consultation; Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Psychotherapy; Behavioral Disciplines and Activities; Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Sterling McPherson, PhD

  Washington State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention group and control group

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 26, 2020
• Study Start: September 23, 2019
• Primary Completion: January 31, 2020
• Study Completion: February 28, 2020
• Last Updated: June 19, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)