Implementation of Problem-Solving Treatment in Community Health Centers (PST-Aid)

Официальное название

Type III Hybrid Effectiveness-Implementation Trial of a Clinical Decision Support System for the Implementation of Problem-Solving Treatment in Community Health Centers

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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

Первичные конечные точки

• Change in Implementation Strategy Usability Scale (ISUS) score [Срок оценки: Baseline, 3 months, 6 months]
• Change in Participant Responsiveness Scale (PRS) score [Срок оценки: Baseline, 3 months, 6 months]
• Change in Intervention Appropriateness Measure (IAM) score [Срок оценки: Baseline, 3 months, 6 months]
• Adoption over time [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline, 4 weeks, 9 weeks]
• Client Satisfaction Questionnaire-16 [Срок оценки: 9 weeks]
• Change in Quality of Life in Neurological Disorders Social Relations scale (Neuro-QOL) score [Срок оценки: Baseline, 4 weeks, 9 weeks]
• Initial fidelity (PST Fidelity Scale) [Срок оценки: 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 [Срок оценки: Expert clinicians review audiotapes of therapy sessions or mock interview for each clinician participant over a six-month period of time after initial training]

Вторичные конечные точки (7)

• Framework for Modifications and Adaptations of Evidence-based Interventions [Срок оценки: 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 [Срок оценки: Baseline, 4 weeks, 9 weeks]
• Costs over time [Срок оценки: Baseline, 3 months, 6 months, 12 months]
• Change in PST Task Self Efficacy Scale score [Срок оценки: Baseline, 4 weeks, 9 weeks]
• Change in Behavioral Activation for Depression Scale score [Срок оценки: Baseline, 4 weeks, 9 weeks]
• Change in General Anxiety Disorder-7 (GAD-7) score [Срок оценки: Baseline, 4 weeks, 9 weeks]
• Top Problems Assessment over time [Срок оценки: Baseline, 4 weeks, 9 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• OCHIN, Inc. — Portland

Идентификаторы

NCT: NCT06494384 · STUDY00020564 · P50MH115837-06

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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