NCT04155385

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2019

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 1, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

May 20, 2022

Status Verified

May 1, 2022

Enrollment Period

2.2 years

First QC Date

November 1, 2019

Last Update Submit

May 13, 2022

Conditions

Alcohol Use DisorderSubstance Use Disorders

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Clinician log-ins to dashboard

    6 months

Study Arms (2)

Measurement-only

ACTIVE COMPARATOR

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

Measurement and feedback

EXPERIMENTAL

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

Other: MeasurementOther: Feedback

Interventions

MeasurementOTHER

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.

Measurement and feedbackMeasurement-only
FeedbackOTHER

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.

Measurement and feedback

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related 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. eCollection 2022.

    PMID: 35463505RESULT

Related Links

MeSH Terms

Conditions

AlcoholismSubstance-Related Disorders

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Kevin A Hallgren, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Non-randomized two-arm clinical trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, School of Medicine: Psychiatry

Study Record Dates

First Submitted

November 1, 2019

First Posted

November 7, 2019

Study Start

October 4, 2019

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

May 20, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)