Clinical trial NCT06494384: Implementation of Problem-Solving Treatment in Community Health Centers (PST-Aid)
Official title: Type III Hybrid Effectiveness-Implementation Trial of a Clinical Decision Support System for the Implementation of Problem-Solving Treatment in Community Health Centers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-07-10
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Although evidence-based clinical interventions (CI) are a preferred treatment option for patients with depression, CIs are rarely available in community primary care settings. When available, CIs are often delivered with poor fidelity and abandoned by practitioners during the initial months post-training. Identifying effective implementation strategies to support the adoption, reach, and sustained use with fidelity of these CIs could enhance the effectiveness of primary care-based treatment of depression, as primary care is where most treatment for this disorder is delivered. Current models of primacy care practitioner training and supervision follow standard formal didactic procedures that might not be sufficient for successful adoption, high-fidelity delivery, and sustainment of CIs. Automated decision support tools and feedback systems embedded in health informatics technology have been found to be effective in supporting the use of best practices and hence might be useful for the transition from training to sustained CI use. In practice, however, these tools are ignored by practitioners, have mixed success on outcomes, and can hinder clinical care owing to poor design. Problem Solving Treatment Aid (PST-Aid), an educate and reorganize implementation strategy, is a web-based app that promotes practitioner-client collaboration in the use of PST for goal setting and action planning. A pilot randomized trial comparing Problem Solving Treatment (PST) training-as-usual to training plus PST-Aid found PST-Aid was deemed to be appropriate and usable to both practitioner and client users with preliminary support for benefits in depression outcomes.

Detailed description: This study is a hybrid type III effectiveness-implementation randomized clinical trial comparing standard PST implementation with PST augmented by the PST-Aid implementation strategy. The study will test whether:

1. PST Aid results in improved implementation outcomes (initial and sustained fidelity, adoption, reach, and reduced reactive adaptations);
2. Changes in usability, engagement, and appropriateness mediate the effect of PST Aid on implementation outcomes; and
3. PST Aid is more effective in reducing client depressive symptoms and improving functioning.

Eligibility criteria: Inclusion Criteria:

* Practitioner Participants. (a) are employed by a clinic that is an OCHIN clinical network member;
* Practitioner Participants. (b) hold a master's degree in social work, psychology, counseling, or a related field;
* Practitioner Participants. (c) provide psychotherapeutic care in the OCHIN network;
* Practitioner Participants. (d) have not previously received formal training in PST as defined by University of Washington Advancing Integrated Mental Health Solutions Center (AIMS) criteria;
* Practitioner Participants. (e) are not currently receiving specialized training outside of standard clinic support to implement a depression-specific psychosocial intervention; and
* Practitioner Participants. (f) are English-speaking.
* Client Participants. a) 18+,
* Client Participants. b) English-speaking,
* Client Participants. c) have a diagnosis of unipolar depression per provider report, and
* Client Participants. d) have a PHQ-9 score ≥ 10, which is above the clinical cutoff for depression symptoms.

Exclusion Criteria:

* Client Participants. (a) history or presence of psychiatric diagnoses other than unipolar, nonpsychotic depression or anxiety disorders,
* Client Participants. (b) active suicidal ideation,
* Client Participants. (c) current alcohol or substance abuse disorders, or
* Client Participants. (d) have dementia
* Client Participants. (e) all exclusion criteria cannot be confirmed via provider report.
* Practitioner Participants. Exclusion criteria are those that do not meet the inclusion criteria listed above.

Primary outcomes:
measure: Change in Implementation Strategy Usability Scale (ISUS) score
timeFrame: Baseline, 3 months, 6 months
measure: Change in Participant Responsiveness Scale (PRS) score
timeFrame: Baseline, 3 months, 6 months
measure: Change in Intervention Appropriateness Measure (IAM) score
timeFrame: Baseline, 3 months, 6 months
measure: Adoption over time
timeFrame: Baseline, 7 months post-initial training in the intervention, and end of the individual's study participation period, assessed as the study withdrawal date or 24 months post-training, whichever is first
measure: Reach over time
timeFrame: Baseline, 7 months post-initial training in the intervention, and end of the individual's study participation period, assessed as the study withdrawal date or 24 months post-training, whichever is first
measure: Change in Patient Health Questionnaire (PHQ-9) score
timeFrame: Baseline, 4 weeks, 9 weeks
measure: Client Satisfaction Questionnaire-16
timeFrame: 9 weeks
measure: Change in Quality of Life in Neurological Disorders Social Relations scale (Neuro-QOL) score
timeFrame: Baseline, 4 weeks, 9 weeks
measure: Initial fidelity (PST Fidelity Scale)
timeFrame: Expert clinicians review audiotapes of therapy sessions or mock interview for each clinician participant over a six-month period of time prior to certification in the intervention
measure: Sustained fidelity
timeFrame: Expert clinicians review audiotapes of therapy sessions or mock interview for each clinician participant over a six-month period of time after initial training
Secondary outcomes:
measure: Framework for Modifications and Adaptations of Evidence-based Interventions
timeFrame: End of the individual's study participation period, assessed as the study withdrawal date or 24 months post-training, whichever is first
measure: Quality of goal setting and action planning over time
timeFrame: Baseline, 4 weeks, 9 weeks
measure: Costs over time
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Change in PST Task Self Efficacy Scale score
timeFrame: Baseline, 4 weeks, 9 weeks
measure: Change in Behavioral Activation for Depression Scale score
timeFrame: Baseline, 4 weeks, 9 weeks
measure: Change in General Anxiety Disorder-7 (GAD-7) score
timeFrame: Baseline, 4 weeks, 9 weeks
measure: Top Problems Assessment over time
timeFrame: Baseline, 4 weeks, 9 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: OCHIN, Inc.
state: Oregon
Study officials:
affiliation: University of Washington
name: Patrick Raue, PhD
role: PRINCIPAL_INVESTIGATOR
References: