Working to Implement and Sustain Digital Outcome Measures (WISDOM)

Randomized Trial of a Leadership and Organizational Change Strategy to Improve the Implementation and Sustainment of Digital Measurement-based Care in Youth Mental Health Services

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.

Study Overview

• Status: Completed
• Conditions: Behavioral Symptoms; Implementation
• Intervention / Treatment: Behavioral: Leadership for Organization Change and Implementation (LOCI); Behavioral: Training and Technical Assistance Only

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 686
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92093
      • University of California, San Diego
  • Florida
    • Orlando, Florida, United States, 32816
      • University of Central Florida
  • Idaho
    • Boise, Idaho, United States, 83725
      • Boise State University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LOCI (Intervention); 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.	Behavioral: Leadership for Organization Change and Implementation (LOCI); LOCI is a multicomponent implementation strategy that engages organizational executives and first-level leaders (i.e., those who administratively supervise clinicians) to build an organizational climate to support the implementation of a focal evidence-based practice (EBP) with fidelity. In this study, the focal EBP is the OQ-A system. LOCI includes two overarching components: (1) monthly organizational strategy meetings between executives and LOCI consultants/trainers to develop and embed policies, procedures, and practices that support implementation of a focal EBP, and (2) training and coaching for first-level leaders, to develop their skills in leading implementation. The aim of these components is to develop an organizational implementation climate in which clinicians' perceive that use of the OQ-A with high fidelity is expected, supported, and rewarded.; Behavioral: Training and Technical Assistance Only; All leaders and clinicians in participating clinics will receive standardized OQ-A training and technical assistance provided by the OQ-A purveyor organization. This includes an initial, 6-hr, in-person OQ-A training; two, live, virtual, 1-hr booster trainings, offered 3 and 5 months after the initial training; and, year-round technical assistance from the OQ-A purveyor organization. Technical assistance includes virtual training sessions, online library of training videos, and customer care representative for technical support. In addition, to encourage participation in the study, a set of four 1-hr, web-based general leadership seminars will be offered to leaders in the control condition. These will cover topics ranging from effective leadership, to giving effective feedback.
Active Comparator: Training and Technical Assistance only (Control); 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.	Behavioral: Training and Technical Assistance Only; All leaders and clinicians in participating clinics will receive standardized OQ-A training and technical assistance provided by the OQ-A purveyor organization. This includes an initial, 6-hr, in-person OQ-A training; two, live, virtual, 1-hr booster trainings, offered 3 and 5 months after the initial training; and, year-round technical assistance from the OQ-A purveyor organization. Technical assistance includes virtual training sessions, online library of training videos, and customer care representative for technical support. In addition, to encourage participation in the study, a set of four 1-hr, web-based general leadership seminars will be offered to leaders in the control condition. These will cover topics ranging from effective leadership, to giving effective feedback.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Fidelity to the OQ-A System Experienced by the Youth (0-100%)	Fidelity to the OQ-A will be measured by using electronic meta-data from the OQ-A system combined with caregiver reported information on the number of sessions the youth attended. For each youth, a fidelity index will be generated that represents the product of two quantities: (a) the youth's completion rate (i.e., number of measures administered relative to the number of sessions attended within the 6-month observation period), and (b) the youth's viewing rate (i.e., the number of feedback reports viewed by the clinician relative to the number of measures administered). Note that this product is equivalent to the ratio of viewed feedback reports to total sessions; it represents an events/trials proportion. MBC fidelity index scores summarize the level of MBC fidelity experienced by each youth (range=0-1). Higher scores indicate the youth experienced greater fidelity to MBC.	0-6 months after youth's baseline/ entry into treatment
Change From Baseline to 6-months in Youth Total Problems Score on the Short Form Assessment for Children (SAC) - Phase I Cohort	The SAC Total Problem Score is a 48-item measure of youth internalizing (e.g., anxious, depressed) and externalizing (e.g., aggressive, noncompliant, overactive) behaviors (range=0-96) completed by caregivers of youth. Total Problem Score was assessed at baseline (youth's entry into treatment) and monthly for 6 months, change from baseline to month 6 is reported.	0-6 months after youth's baseline/ entry into treatment
Change From Baseline to 6-months in Youth Total Problems Score on the Short-form Assessment for Children (SAC) - Phase II Cohort	The SAC Total Problem Score is a 48-item measure of youth internalizing (e.g., anxious, depressed) and externalizing (e.g., aggressive, noncompliant, overactive) behaviors (range=0-96) completed by caregivers of youth. Total Problem Score was assessed at baseline (youth's entry into treatment) and monthly for 6 months, change from baseline to month 6 is reported.	0-6 months after youth's baseline/ entry into treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in First-level Leaders' Implementation Leadership (ILS)	Clinicians will assess the extent to which their first-level leaders (e.g., clinical program manager) exhibit implementation leadership behaviors with regard to the OQ-A using the 12-item Implementation Leadership Scale (ILS). Responses are made on a 0 (not at all) to 4 (very great extent) scale. Total scores are calculated as the mean of all items. Higher scores indicate more extensive demonstration of implementation leadership behaviors. This outcome will be assessed at baseline, 4-, 8-, 12-, and 18-months. Clinician responses will be aggregated to the clinic level as appropriate.	0-18 months
Change from Baseline in First-level Leaders' Transformational Leadership (MLQ)	Clinicians will assess the extent to which their first-level leaders exhibit transformational leadership behaviors using the Multifactor Leadership Questionnaire (MLQ). Responses are made on a 5-point scale ("Not at all" to "Frequently, if not always"). Consistent with prior studies, we will use the 20-item transformational leadership total score, calculated as the mean of four subscales: idealized influence, inspirational motivation, intellectual stimulation, and individual consideration. This outcome will be assessed at baseline, 4-, 8-, 12-, and 18-months. Clinician responses will be aggregated to the clinic level as appropriate.	0-18 months
Change from Baseline in Clinic Implementation Climate for OQ-A	Clinicians' perceptions of their clinics' implementation climate for OQ-A will be measured using the 18-item Implementation Climate Scale (ICS). Responses are made on a 0 (Not at All) to 4 (A Very Great Extent) scale with the total score calculated as the mean of all items. Higher scores indicate higher levels of implementation climate for OQ-A. This outcome will be assessed at baseline, 4-, 8-, 12-, and 18-months. Clinician responses will be aggregated to the clinic level as appropriate.	0-18 months

Collaborators and Investigators

• Sponsor: Boise State University
• Collaborators: National Institute of Mental Health (NIMH); University of Pennsylvania; University of California, San Diego; University of Central Florida
• Investigators: Principal Investigator: Nate Williams, PhD, Boise State University

Publications and helpful links

Helpful Links

• Information about Leadership for Organizational Change for Implementation (LOCI).
• Information about the digital measurement-based care system, OQ-A.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): September 17, 2022
• Study Completion (Actual): September 17, 2022

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: September 18, 2019
• First Posted (Actual): September 19, 2019

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: implementation science; behavioral health; youth mental health; measurement-based care; evidence-based practice; LOCI; leadership
• Additional Relevant MeSH Terms: Behavioral Symptoms
• Other Study ID Numbers: 8424 (Fred Hutch/University of Washington Cancer Consortium); R01MH119127 (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