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Dynamic Assessment and Referral System - Evaluation (DARSSA)

Primary Purpose

Smoking, Alcohol Abuse, Drug Abuse

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Self-administered computerized assessment for tobacco, substance abuse, and alcohol use.
Self-Administered Computerized Assessment and Counseling for Tobacco, Alcohol, and Substance Abuse
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Smoking focused on measuring Detection of tobacco, alcohol, and drug use.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • UMass Memorial Medical Center - university campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Minimal Intervention Control

DARSSA Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
When the intervention (DARSSA) group is compared to the treatment as usual group, is there an increase in the amount of education/counseling/referral for emergency room patients who report tobacco use, alcohol use, and/or substance abuse.

Full Information

First Posted
June 24, 2010
Last Updated
April 8, 2015
Sponsor
University of Massachusetts, Worcester
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1. Study Identification

Unique Protocol Identification Number
NCT01153373
Brief Title
Dynamic Assessment and Referral System - Evaluation
Acronym
DARSSA
Official Title
The Dynamic Assessment and Referral System for Substance Abuse: Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Screening process. All patients who verbally consent to being screened by the RA will undergo a computer assisted screening for substance abuse (Rapid Screener) administered by the research assistant. Patients who use tobacco, misuse alcohol, or use illicit drugs will be further screened for eligibility to participate in the randomized trial. Eligible patients will be invited to participate and will sign the consent form. Participants will then be assigned to one of the two conditions by the computer using a random number generator. Results obtained as part of the Rapid Screener will be for research purposes only. They will not be reported to healthcare providers, unless the participant is enrolled into the study and is assigned to the DARSSA Intervention condition (see below). Minimal Intervention Control. 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. This will preserve the treatment-as-usual nature of the baseline while maintaining consistency in the administration of the DARSSA between phases of the study. Although ED clinicians will know that a study is being conducted in the ED, they will not be informed of the results of the research assessment, nor will they be given any instruction or training beforehand to change their standard screening, counseling, and referral practices. This means that substance use screening is likely to be inconsistent and counseling or referrals by provider rare. To maintain ethical standards, the RAs will provide a substance abuse treatment resource list (passive referral list) to all subjects who screen positive, even though this often does not happen during routine clinical practice. Additionally, suicidal ideation is not directly assessed as part of the study, but it is possible that participants will spontaneously report suicidal ideation. If this happens, the RA will notify the treating physician. Both of these efforts could conceivably introduce interventions the patient may not otherwise have received, but there is no viable alternative if the investigators are to ensure patient safety. DARSSA Intervention. All participants randomized to the DARSSA Intervention will be given instructions for how to complete the assessment. Since the DARSSA is self-administered and, like all Polaris products, does not require computer literacy, instructions will be simple and do not require a clinician to administer. 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. Any additional assessment or counseling will be optional and left to individual provider practice. We considered creating a standardized counseling protocol but decided against it. We want to maintain an ecologically valid evaluation. In the "real world," providers would not be given extensive health behavior counseling training or asked to follow a standardized counseling protocol when implementing the DARSSA. Training providers on health behavior counseling would act as an additional intervention in its own right, and it could potentially mask our ability to determine what effect the DARSSA alone is having.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Alcohol Abuse, Drug Abuse
Keywords
Detection of tobacco, alcohol, and drug use.

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
758 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Minimal Intervention Control
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
DARSSA Intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-administered computerized assessment for tobacco, substance abuse, and alcohol use.
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-Administered Computerized Assessment and Counseling for Tobacco, Alcohol, and Substance Abuse
Intervention Description
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.
Primary Outcome Measure Information:
Title
Prevalence of detected tobacco, alcohol, and drug use in emergency room patients.
Description
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.
Time Frame
November 2009 - June 2013
Secondary Outcome Measure Information:
Title
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.
Description
When the intervention (DARSSA) group is compared to the treatment as usual group, is there an increase in the amount of education/counseling/referral for emergency room patients who report tobacco use, alcohol use, and/or substance abuse.
Time Frame
November 2009 - June 2013

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Age 18 years or older and receiving treatment in the ED Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edwin Boudreaux, PhD
Organizational Affiliation
UMass Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMass Memorial Medical Center - university campus
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28461283
Citation
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.
Results Reference
derived
PubMed Identifier
26542471
Citation
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.
Results Reference
derived

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Dynamic Assessment and Referral System - Evaluation

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