Working to Implement and Sustain Digital Outcome Measures (WISDOM)

Boise State University

Status: Completed

Conditions: Implementation; Behavioral Symptoms

Treatments: Behavioral: Training and Technical Assistance Only; Behavioral: Leadership for Organization Change and Implementation (LOCI)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04096274

8424 (Other Identifier)

R01MH119127 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will investigate the effects of an organizational implementation strategy called Leadership and Organizational Change for Implementation (LOCI), relative to training and technical assistance only, on fidelity to, and youth service outcomes of, a well-established digital measurement-based care intervention called the Outcomes Questionnaire-Analyst in outpatient community mental health clinics.

Full description

Using a cluster randomized, controlled, hybrid type III effectiveness-implementation design, this trial will investigate the effects of LOCI on the fidelity and and clinical outcomes of a digital measurement-based care (MBC) system called the Outcomes Questionnaire Analyst (OQ-A). The trial will enroll up to 22 outpatient mental health clinics that serve youth and randomly assign them using covariate constrained randomization to either LOCI or training and technical assistance only. Within each clinic, up to 2 first level leaders will be recruited (max N of 40 total) and a minimum of 3 clinicians will be recruited per site (60 total). Data on youth outpatients who receive services will be collected in two phases. In each phase, a unique cohort of 360 caregivers of youth who participate in services will be sampled from the participating clinics. Caregivers will report on the service outcomes and experiences of eligible youth who receive services. The total caregiver enrollment for two phases will be 720 (360*2).

Enrollment: 686 patients

Sex: All

Ages: 4+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Participants for this project will fall into four groups: 1) clinic executives and upper leaders (i.e., Chief Executive Officer, Executive Directors, program administrators, n=20), 2) clinic first-level leaders (i.e. clinical supervisors, n=20), 3) clinicians serving children with emotional and behavioral disorders (n=120), and 4) caregivers of children with emotional and behavioral disorders who receive outpatient mental health services within participating clinics (n=720). Caregivers will be recruited in two distinct cohorts of 360 each.

Inclusion criteria for all groups of participants are intentionally broad in line with the pragmatic nature of the trial.

Inclusion Criteria for Clinics

1. Provide outpatient psychotherapy services to children ages 4 to 18 who have emotional and/ or behavioral disorders and their families
2. Have at least 3 full time equivalent clinicians on staff
3. Not currently implementing a digital measurement-based care system clinic wide

Inclusion Criteria for Executives and Upper Leaders

1. Identified as Chief Executive Officer, Executive Director, or high-level administrator at an enrolled clinic

Inclusion Criteria for first-level leaders

1. Identified as a clinical supervisor or clinical work-group supervisor/ leader at an enrolled clinic

Inclusion Criteria for Clinicians

1. Employed as staff at participating clinic
2. Provides outpatient mental health services (psychotherapy) to youth clients

Inclusion Criteria for Caregivers of Youth Who Receive Services at Participating Clinics

1. Child is ages 4 to 18 years at intake,
2. Child has been diagnosed with an emotional or behavioral disorder by clinic staff
3. Clinical staff at the site determined that the youth's treatment needs can be appropriately addressed by the clinic

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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686 participants in 2 patient groups

LOCI (Intervention)

Experimental group

Description:

In clinics assigned to the LOCI condition, executives and first-level leaders will receive leadership training and coaching to support implementation of the OQ-A system. In addition, leaders and clinicians in this condition will receive training and technical assistance to implement the OQ-A measurement-based care system.

Treatment:

Behavioral: Training and Technical Assistance Only

Behavioral: Leadership for Organization Change and Implementation (LOCI)

Training and Technical Assistance only (Control)

Active Comparator group

Description:

In clinics assigned to the control group, leaders and clinicians will receive training and technical assistance to implement the OQ-A measurement-based care system. In addition, to support enrollment in this condition, leaders in this condition will be offered access to general web-based leadership seminars.

Treatment:

Behavioral: Training and Technical Assistance Only