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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04155385
Other study ID # STUDY00007996
Secondary ID K01AA024796
Status Completed
Phase N/A
First received
Last updated
Start date October 4, 2019
Est. completion date December 1, 2021

Study information

Verified date May 2022
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 1, 2021
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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.
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.

Locations

Country Name City State
United States University of Washington Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
University of Washington National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hallgren KA, Cohn EB, Ries RK, Atkins DC. Delivering Remote Measurement-Based Care in Community Addiction Treatment: Engagement and Usability Over a 6-Month Clinical Pilot. Front Psychiatry. 2022 Apr 7;13:840409. doi: 10.3389/fpsyt.2022.840409. eCollectio — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Measure completion Logged number of weekly measurement-based care surveys that were completed 6 months
Primary Discussion of topics measured by the weekly progress measure 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). About 6 weeks after enrollment
Primary Changes in treatment outcomes as measured by the weekly progress measure 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. 6 months
Secondary Clinician log-ins to dashboard Number of log-ins to the clinician-facing dashboard, which will be tracked automatically by the dashboard website. 6 months
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