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SmokingPhase 2DARSSANCT01153373

Dynamic Assessment and Referral System - Evaluation

A Phase 2 study testing Self-administered computerized assessment for tobacco, substance abuse, and alcohol use. and Self-Administered Computerized Assessment and Counseling for Tobacco, Alcohol, and Substance Abuse in people with Smoking and Alcohol Abuse, run by University of Massachusetts, Worcester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Smoking, Alcohol Abuse, Drug Abuse
What is being tested?
Self-administered computerized assessment for tobacco, substance abuse, and alcohol use. and Self-Administered Computerized Assessment and Counseling for Tobacco, Alcohol, and Substance Abuse
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
758 participants
Where
1 siteUnited States
Study dates
Jun 2010to Apr 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UMass Memorial Medical Center - university campus

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: The Dynamic Assessment and Referral System for Substance Abuse: Evaluation

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.

Read the 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.

Being tested
Self-administered computerized assessment for tobacco, substance abuse, and alcohol use., Self-Administered Computerized Assessment and Counseling for Tobacco, Alcohol, and Substance Abuse
Keywords
Detection of tobacco, alcohol, and drug use.
Medical subject headings
Smoking, Alcoholism, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

  • Self-Administered Computerized Assessment and Counseling for Tobacco, Alcohol, and Substance AbuseBehavioural

    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.

Study groups in NCT01153373
Study groupRoleWhat they receive
Minimal Intervention ControlPlacebo comparatorAll 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.
Receives: Behavioral: Self-administered computerized assessment for tobacco, substance abuse, and alcohol use.
DARSSA InterventionActive comparatorAll 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.
Receives: Behavioral: Self-Administered Computerized Assessment and Counseling for Tobacco, Alcohol, and Substance Abuse

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: November 2009 - June 2013

Secondary outcomes (1)
  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.

    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.

    Measured: November 2009 - June 2013

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
758 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01153373
Sponsor's protocol ID
H-13419
Acronym
DARSSA
Status last verified
Apr 2015
First submitted
24 Jun 2010
Last updated
9 Apr 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28461283
  • 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.

    PubMed 26542471

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Self-administered computerized assessment for tobacco, substance abuse, and alcohol use. and Self-Administered Computerized Assessment and Counseling for Tobacco, Alcohol, and Substance Abuse in people with Smoking and Alcohol Abuse, run by University of Massachusetts, Worcester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of detected tobacco, alcohol, and drug use in emergency room patients. (time frame: November 2009 - June 2013). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01153373, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2015.

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Dynamic Assessment and Referral System - Evaluation | AzTrials