Dynamic Assessment and Referral System - Evaluation

NCT01153373 | Completed Phase 2 DMC

• 1 other identifier: H-13419
• Study Type: interventional
• Target: 758
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators study will use a randomized controlled design. Eligible and consenting participants will be randomly assigned to one of two conditions: (1) DARSSA Intervention condition, or (2) Minimal Intervention Control condition. All enrolled participants will undergo the DARSSA baseline assessment and will be interviewed immediately following their ED discharge to assess relevant outcomes, such as whether they were asked about substance use and given a referral during their visit. This is referred to as the post-visit interview. All risky substance users enrolled during all phases will be interviewed again at 1- and 3-months post-visit to assess substance use, treatment engagement, and other outcomes. The primary difference between the two conditions is that, for the DARSSA Intervention condition, the subjects will have their reports printed and will be given the option of receiving the dynamic referral, while for the Minimal Intervention Control condition the subjects will undergo the assessment and will receive the standard substance abuse treatment referral list currently in use clinically at each site. The number of assessments and interactions with research staff will remain equal between the two conditions, with the only difference being the active intervention of the DARSSA reports and referrals, and any counseling by healthcare providers this engenders. The remainder of this section describes each phase of the study and enrollment procedures.

Conditions

Smoking; Alcohol Abuse; Drug Abuse

Keywords

Detection of tobacco, alcohol, and drug use.

Outcome Measures

Primary Outcomes (1)

• Prevalence of detected tobacco, alcohol, and drug use in emergency room patients.

  When comparing the intervention (DARSSA) group to the treatment as usual group, is there an increase in the detected prevalence of tobacco use, alcohol use, and drug abuse.

  November 2009 - June 2013

Secondary Outcomes (1)

• Increase in delivery of health care (i.e. - education/counseling/referral) for emergency room patients that report tobacco use, alcohol use, and/or substance abuse.

  November 2009 - June 2013

Study Arms (2)

Minimal Intervention Control

PLACEBO COMPARATOR

All patients that give consent to participate in the study ("participants") who are randomly assigned to the control condition will complete the computerized DARSSA for assessment purposes only. The reports will not be printed or dynamic referrals generated, and all patients will receive treatment-as-usual by their ED providers.

Behavioral: Self-administered computerized assessment for tobacco, substance abuse, and alcohol use.

DARSSA Intervention

ACTIVE COMPARATOR

All participants randomized to the DARSSA Intervention will be given instructions for how to complete the assessment. Once completed, the treating emergency physician will be expected to (1) give substance using patients the Patient Feedback Report, (2) recommend they review it carefully, and (3) encourage them to consider following up with the referrals.

Behavioral: Self-Administered Computerized Assessment and Counseling for Tobacco, Alcohol, and Substance Abuse

Interventions

Self-administered computerized assessment for tobacco, substance abuse, and alcohol use. BEHAVIORAL

All patients that give consent to participate in the study ("participants") who are randomly assigned to the control condition will complete the computerized DARSSA for assessment purposes only.

Minimal Intervention Control

Self-Administered Computerized Assessment and Counseling for Tobacco, Alcohol, and Substance Abuse BEHAVIORAL

All participants randomized to the DARSSA Intervention will be given instructions for how to complete the assessment. Once completed, the treating emergency physician will be expected to (1) give substance using patients the Patient Feedback Report, (2) recommend they review it carefully, and (3) encourage them to consider following up with the referrals.

DARSSA Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Age 18 years or older and receiving treatment in the ED

You may not qualify if:

• sustained altered mental status (e.g., psychosis, delirium, disorientation, unresponsive)
• hostile or agitated behavior
• sexual assault victims
• trauma patients who are on backboards or who must remain supine
• severe illness that would preclude conversation or interface with a computer (e.g., intubation, persistent vomiting, severe pain)
• or factors precluding follow-up, like transient residence or lack of a telephone.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

UMass Memorial Medical Center - university campus

Worcester, Massachusetts, 01655, United States

Location

Related Publications (2)

• Haskins BL, Davis-Martin R, Abar B, Baumann BM, Harralson T, Boudreaux ED. Health Evaluation and Referral Assistant: A Randomized Controlled Trial of a Web-Based Screening, Brief Intervention, and Referral to Treatment System to Reduce Risky Alcohol Use Among Emergency Department Patients. J Med Internet Res. 2017 May 1;19(5):e119. doi: 10.2196/jmir.6812.

  PMID: 28461283 DERIVED

• Boudreaux ED, Abar B, Haskins B, Bauman B, Grissom G. Health evaluation and referral assistant: a randomized controlled trial to improve smoking cessation among emergency department patients. Addict Sci Clin Pract. 2015 Nov 5;10:24. doi: 10.1186/s13722-015-0045-2.

  PMID: 26542471 DERIVED

MeSH Terms

Conditions

Smoking; Alcoholism; Substance-Related Disorders

Interventions

Tobacco Products; Ethanol; Counseling

Condition Hierarchy (Ancestors)

Behavior; Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture; Alcohols; Organic Chemicals; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Edwin Boudreaux, PhD

  UMass Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principle Investigator

Study Record Dates

• First Submitted: June 24, 2010
• First Posted: June 30, 2010
• Study Start: June 1, 2010
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 9, 2015

Record last verified: 2015-04

Locations

US (1)