Addiction Treatment Outcome Monitoring Study

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.

Study Overview

• Status: Completed
• Conditions: Substance Use Disorders; Alcohol Use Disorder
• Intervention / Treatment: Other: Measurement; Other: Feedback

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure completion	Logged number of weekly measurement-based care surveys that were completed	6 months
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Kevin A Hallgren, PhD, University of Washington

Publications and helpful links

General Publications

• 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. eCollection 2022.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2019
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: November 1, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 7, 2019

Study Record Updates

• Last Update Posted (Actual): May 20, 2022
• Last Update Submitted That Met QC Criteria: May 13, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism; Disease
• Other Study ID Numbers: STUDY00007996; K01AA024796 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No