Working to Implement and Sustain Digital Outcome Measures

Study Results

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Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

686 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2022-09-17

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Implementation Behavioral Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Caregivers

Clinicians and caregivers of youth were naïve to condition; however, masking of clinic leaders was not possible due to the nature of the LOCI strategy (which entails leadership training and consultation).

Study Groups

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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.

Group Type EXPERIMENTAL

Leadership for Organization Change and Implementation (LOCI)

Intervention Type BEHAVIORAL

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.

Training and Technical Assistance Only

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Training and Technical Assistance Only

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

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

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

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

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

Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes