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Addiction Treatment Outcome Monitoring Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04155385
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : November 12, 2019
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Kevin Hallgren, University of Washington

Brief Summary:
This research evaluates a tool designed for measurement-based care in addiction treatment. Patients in addiction treatment will be invited to complete weekly measures indicating treatment progress and goals. For half the patients, their addiction treatment clinician will be able to view their weekly progress and goals via a secure dashboard. The research will test the feasibility and acceptability of the measurement-based care tool and will evaluate its impact on within-session discussion topics and clinical outcome measures.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Substance Use Disorders Other: Measurement Other: Feedback Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Non-randomized two-arm clinical trial.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Addiction Treatment Outcome Monitoring Study
Actual Study Start Date : October 4, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Measurement-only
Patients will complete weekly measures of treatment progress and goals; however, the information from these measures will not be shared with clinicians or patients.
Other: Measurement
The measurement system collects information about patients' treatment progress and goals in key areas that are associated with long-term clinical outcomes (e.g., substance use, craving, coping skills, self-efficacy, life satisfaction, depression). Patients complete the measure up to once per week for up to six months.

Experimental: Measurement and feedback
Patients will complete weekly measures of treatment progress and goals; the information from these measures will be shared with clinicians.
Other: Measurement
The measurement system collects information about patients' treatment progress and goals in key areas that are associated with long-term clinical outcomes (e.g., substance use, craving, coping skills, self-efficacy, life satisfaction, depression). Patients complete the measure up to once per week for up to six months.

Other: Feedback
The feedback system is a web-based dashboard that displays current and historical results in each of the outcome and goal domains that is measured; it is available to addiction treatment clinicians who are working with patients enrolled in the study.




Primary Outcome Measures :
  1. Measure completion [ Time Frame: 6 months ]
    Logged number of weekly measurement-based care surveys that were completed

  2. Discussion of topics measured by the weekly progress measure [ Time Frame: About 6 weeks after enrollment ]
    Self-reported amount of time spent discussing topics measured in the weekly progress measure. This will be measured via a self-report questionnaire ("In-Session Discussion Topics" questionnaire), which was generated for the current study. The measure will assess the extent to which they discussed each of the following topics in their most recent treatment session: Drinking/drug use, cravings, coping strategies, abstinence self-efficacy, outlook on life, mental health, therapeutic alliance, and treatment goals. Each item is reported on a 4-point Likert scale (minimum value = 0 "did not discuss", maximum value = 3 "discussed extensively" -- higher scores do not necessarily indicate "better" clinical outcomes; however, we hypothesize that the measurement-based care tool will increase the in-session discussion of these topics, and therefore higher outcomes in the measurement-and-feedback group would be consistent with our hypothesis).

  3. Changes in treatment outcomes as measured by the weekly progress measure [ Time Frame: 6 months ]
    Self-reported responses to the weekly progress measure will be evaluated using longitudinal growth curve models. The check-in measure was developed for the current study and consists of items drawn from several existing measures, including the Substance Use Recovery Evaluator, Alcohol Abstinence Self-Efficacy scale, Working Alliance Inventory, and Patient Health Questionnaire-2. The measure is called "The Weekly Check-In" and it provides a "total recovery score" ranging from 0 to 100, with higher scores indicating better outcomes.


Secondary Outcome Measures :
  1. Clinician log-ins to dashboard [ Time Frame: 6 months ]
    Number of log-ins to the clinician-facing dashboard, which will be tracked automatically by the dashboard website.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. At least 18 years old.
  2. Self-reports that they are a patient at Harborview Mental Health and Addiction Services (HMHAS) clinic.
  3. Self-reports that they are receiving services at HMHAS clinic for an alcohol or drug-related concern.
  4. Has a smartphone with a working phone number and a mobile plan that allows text messages and internet connection.
  5. AUDIT-C score indicates past-year hazardous drinking (summed score is at least 3 or 4 for women or men, respectively), or self-reports any drug use for non-medical reasons in the past year.
  6. Does not anticipate moving away from the Seattle area within 6 months.
  7. Does not anticipate becoming incarcerated in next 6 months.
  8. Able to speak and read English (based on self-report).
  9. Must be receiving clinical services from an HMHAS clinician who is also participating in the study, which will be evidenced by having at least 3 appointments with a participating HMHAS clinician that were either completed within the past three months or are scheduled to occur within the next three months, verified by the electronic health record.

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155385


Contacts
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Contact: Kevin A Hallgren, PhD 206-616-2906 khallgre@uw.edu

Locations
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United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Kevin A Hallgren, PhD         
Principal Investigator: Kevin A Hallgren, PhD         
Sponsors and Collaborators
University of Washington
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Kevin A Hallgren, PhD University of Washington
  Study Documents (Full-Text)

Documents provided by Kevin Hallgren, University of Washington:
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Responsible Party: Kevin Hallgren, Associate Professor, School of Medicine: Psychiatry, University of Washington
ClinicalTrials.gov Identifier: NCT04155385    
Other Study ID Numbers: STUDY00007996
K01AA024796 ( U.S. NIH Grant/Contract )
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Alcoholism
Substance-Related Disorders
Pathologic Processes
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders