Type III Hybrid Effectiveness-Implementation Trial of a Clinical Decision Support System for the Implementation of Problem-Solving Treatment in Community Health Centers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Washington
- Enrollment
- 410
- Locations
- 2
- Primary Endpoint
- Change in Implementation Strategy Usability Scale (ISUS) score
Study Overview
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:
- PST Aid results in improved implementation outcomes (initial and sustained fidelity, adoption, reach, and reduced reactive adaptations);
- Changes in usability, engagement, and appropriateness mediate the effect of PST Aid on implementation outcomes; and
- PST Aid is more effective in reducing client depressive symptoms and improving functioning.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change in Implementation Strategy Usability Scale (ISUS) score
Time Frame: Baseline, 3 months, 6 months
Usability will be evaluated with clinician report on the 10-item Implementation Strategy Usability Scale (ISUS), which is based closely on the well-validated System Usability Scale. Ratings are on a 1 to 5 scale and yield a total score from 0 to 100. Half the items are reverse scored; higher total scores reflect greater usability. The ISUS has good inter-item consistency (a = .83) and sensitivity. Research has also demonstrated that the original version of the ISUS (the SUS) functions similarly-and yields similar scores-for adults and youth as young as 11 years.
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
Reach will be calculated as the percentage of clinicians caseloads of patients with a depressive disorder receiving PST.
Change in Participant Responsiveness Scale (PRS) score
Time Frame: Baseline, 3 months, 6 months
Clinicians will complete the Participant Responsiveness Scale (PRS), an adapted version of the 12-item Patient Responsiveness Scale tailored to be developmentally appropriate for children aged 8 and above as well as adults. The PRS measures two factors, Participation and Enthusiasm. The original Patient Responsiveness Scale has demonstrated strong reliability (a = .86) and construct validity.
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
Fidelity will be measured using the PST Adherence and Competency Scale (PST Fidelity Scale). The PST Fidelity Scale includes seven items assessing the seven key problem-solving steps rated on a 5 point scale (0=very poor, 5=very good), an average score of 3 or greater indicates a satisfactory performance.Internal consistency is good, with Cronbach alpha ranging from .83 to .89. A Principal Components Analysis found all factors loaded on a common factor accounting for 76.6% of the variance.Interrater reliability has been found to be high (r=.822-.918), with 86% of two-rater comparisons within one point of each other. Initial fidelity will be defined as the hours of training until fidelity-based certification is reached, measured by trainer PST Fidelity Scale ratings of session recordings or mock interviews.
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
Sustained fidelity will be rated via observer coding of recordings of one randomly selected session (or mock interview) per client using the PST Fidelity Scale (i.e., fidelity tool)
Change in Quality of Life in Neurological Disorders Social Relations scale (Neuro-QOL) score
Time Frame: Baseline, 4 weeks, 9 weeks
The Quality of Life in Neurological Disorders Satisfaction with Social Roles scale (Neuro-QOL) is a widely used 8-item measure of functioning in usual social roles, activities, and responsibilities. Factor analyses and Item Response Theory analyses have ensured broad information parameters without differential item functioning by demographics. Scale scores have been validated and normed on thousands of participants in the US general and clinical inpatient and outpatient settings, presenting with a variety of problem areas. Scores provide a T score with a mean of 50 and standard deviation of 10, aligned with a variety of norming samples. An example item stem is: In the past 7 days I am able to do all of my regular family activities. Response options are on a scale of 1 to 5 (1=never, 2-rarely, 3=sometimes, 4=often, 5=always).
Change in Intervention Appropriateness Measure (IAM) score
Time Frame: Baseline, 3 months, 6 months
Clinicians will complete the Intervention Appropriateness Measure (IAM) is a rigorously developed, pragmatic instrument with strong good internal consistency (a = .87) and test-retest reliability (a = .87).
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
Adoption is operationalized as whether or not the clinician completes at least 1 PST session with 3 or more cases at any point during study participation.
Change in Patient Health Questionnaire (PHQ-9) score
Time Frame: Baseline, 4 weeks, 9 weeks
The Patient Health Questionnaire is one of the most used short depression measures. The PHQ features 9 items on a four-point scale (0=not at all, 1=several days, 2=more than half the days, 3=nearly every day), with cutpoints for 5, 10, 15, and 20 representing mild, moderate, moderately severe, and severe levels of depressive symptoms. Four original validation studies were conducted on nearly 10,000 patients, and there have been multiple meta-analyses. Scores have been found valid, with sensitivity of 88% and specificity of 88% for a cut point of 10 has been found for Major Depressive Disorders.
Client Satisfaction Questionnaire-16
Time Frame: 9 weeks
This measure will ask 3 items from the Client Satisfaction Questionnaire-16: Did treatment meet your needs? Are you satisfied with treatment services? Would you use the same treatment again if needed?
Secondary Outcomes
- Framework for Modifications and Adaptations of Evidence-based Interventions(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(Baseline, 4 weeks, 9 weeks)
- Costs over time(Baseline, 3 months, 6 months, 12 months)
- Change in PST Task Self Efficacy Scale score(Baseline, 4 weeks, 9 weeks)
- Change in Behavioral Activation for Depression Scale score(Baseline, 4 weeks, 9 weeks)
- Change in General Anxiety Disorder-7 (GAD-7) score(Baseline, 4 weeks, 9 weeks)
- Top Problems Assessment over time(Baseline, 4 weeks, 9 weeks)
Investigators
Patrick Raue
Professor, Psychiatry and Behavioral Sciences
University of Washington