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

Overview

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.

Interventions

• Behavioral Problem Solving Treatment as usual (PST as usual)
  PST is a skills-based intervention that teaches clients a 7-step approach in which they 1) select a specific problem and define it in concrete terms,2) select a goal that is feasible to reach before next session, 3) brainstorm various ways to accomplish the goal, 4) evaluate pros and cons of each solution, including the likelihood they can actually implement it, 5) select the best solution, 6) create a plan to implement the solution, and 7) evaluate the plan afterward to ascertain the effectiven
• Behavioral Problem Solving Treatment Aid (PST-Aid)
  PST-Aid is an internet-based tool to support the delivery of PST. PST-Aid incorporates decision support for the practitioner as well as client and provides PST treatment support functions (i.e., scaffolding), including patient problem lists and session worksheets. PST-Aid was designed to be used during remote sessions, such that practitioners and clients can interact throughout the session while collaboratively viewing and editing worksheets on their own browsers.This system was developed into a

Primary outcome measures

• Change in Implementation Strategy Usability Scale (ISUS) score [Time frame: Baseline, 3 months, 6 months]
• Change in Participant Responsiveness Scale (PRS) score [Time frame: Baseline, 3 months, 6 months]
• Change in Intervention Appropriateness Measure (IAM) score [Time frame: Baseline, 3 months, 6 months]
• Adoption over time [Time frame: 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]
• Reach over time [Time frame: 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]
• Change in Patient Health Questionnaire (PHQ-9) score [Time frame: Baseline, 4 weeks, 9 weeks]
• Client Satisfaction Questionnaire-16 [Time frame: 9 weeks]
• Change in Quality of Life in Neurological Disorders Social Relations scale (Neuro-QOL) score [Time frame: Baseline, 4 weeks, 9 weeks]
• Initial fidelity (PST Fidelity Scale) [Time frame: 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]
• Sustained fidelity [Time frame: 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 outcome measures (7)

• Framework for Modifications and Adaptations of Evidence-based Interventions [Time frame: End of the individual's study participation period, assessed as the study withdrawal date or 24 months post-training, whichever is first]
• Quality of goal setting and action planning over time [Time frame: Baseline, 4 weeks, 9 weeks]
• Costs over time [Time frame: Baseline, 3 months, 6 months, 12 months]
• Change in PST Task Self Efficacy Scale score [Time frame: Baseline, 4 weeks, 9 weeks]
• Change in Behavioral Activation for Depression Scale score [Time frame: Baseline, 4 weeks, 9 weeks]
• Change in General Anxiety Disorder-7 (GAD-7) score [Time frame: Baseline, 4 weeks, 9 weeks]
• Top Problems Assessment over time [Time frame: Baseline, 4 weeks, 9 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

United States · 1 center

• OCHIN, Inc. — Portland

Identifiers

NCT: NCT06494384 · STUDY00020564 · P50MH115837-06

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗