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Addiction Treatment Outcome Monitoring Study

Primary Purpose

Alcohol Use Disorder, Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Measurement
Feedback
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Measurement-only

Measurement and feedback

Arm Description

Patients will complete weekly measures of treatment progress and goals; however, the information from these measures will not be shared with clinicians or patients.

Patients will complete weekly measures of treatment progress and goals; the information from these measures will be shared with clinicians.

Outcomes

Primary Outcome Measures

Measure completion
Logged number of weekly measurement-based care surveys that were completed
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).
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.

Secondary Outcome Measures

Clinician log-ins to dashboard
Number of log-ins to the clinician-facing dashboard, which will be tracked automatically by the dashboard website.

Full Information

First Posted
November 1, 2019
Last Updated
May 13, 2022
Sponsor
University of Washington
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT04155385
Brief Title
Addiction Treatment Outcome Monitoring Study
Official Title
Addiction Treatment Outcome Monitoring Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 4, 2019 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Substance Use Disorders

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Non-randomized two-arm clinical trial.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Measurement-only
Arm Type
Active Comparator
Arm Description
Patients will complete weekly measures of treatment progress and goals; however, the information from these measures will not be shared with clinicians or patients.
Arm Title
Measurement and feedback
Arm Type
Experimental
Arm Description
Patients will complete weekly measures of treatment progress and goals; the information from these measures will be shared with clinicians.
Intervention Type
Other
Intervention Name(s)
Measurement
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Feedback
Intervention Description
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 Measure Information:
Title
Measure completion
Description
Logged number of weekly measurement-based care surveys that were completed
Time Frame
6 months
Title
Discussion of topics measured by the weekly progress measure
Description
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).
Time Frame
About 6 weeks after enrollment
Title
Changes in treatment outcomes as measured by the weekly progress measure
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Clinician log-ins to dashboard
Description
Number of log-ins to the clinician-facing dashboard, which will be tracked automatically by the dashboard website.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years old. Self-reports that they are a patient at Harborview Mental Health and Addiction Services (HMHAS) clinic. Self-reports that they are receiving services at HMHAS clinic for an alcohol or drug-related concern. Has a smartphone with a working phone number and a mobile plan that allows text messages and internet connection. 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. Does not anticipate moving away from the Seattle area within 6 months. Does not anticipate becoming incarcerated in next 6 months. Able to speak and read English (based on self-report). 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin A Hallgren, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35463505
Citation
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.
Results Reference
result
Links:
URL
https://www.frontiersin.org/articles/10.3389/fpsyt.2022.840409/full
Description
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Addiction Treatment Outcome Monitoring Study

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