Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Depression
  • PTSD
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Phase 1 will consist of observation and qualitative interviews; Phase two will consist of iterative design methods; phase three is a pilot randomized clinical trialMasking: Single (Outcomes Assessor)Masking Description: Research Assistants and expert reviewers of therapy sessions will not be made aware of which condition the therapist is assigned to.Primary Purpose: Health Services Research

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

High quality delivery of evidence-based psychosocial interventions (EBPIs) in primary care medicine is a function of many variables, including clinician training and ready access to EBPI decision support. Importantly, quality is also driven by the clinician's ability to implement the therapeutic ele...

High quality delivery of evidence-based psychosocial interventions (EBPIs) in primary care medicine is a function of many variables, including clinician training and ready access to EBPI decision support. Importantly, quality is also driven by the clinician's ability to implement the therapeutic elements of EBPIs to fidelity and with competence. Even when clinicians undergo rigorous training, and find the intervention components useful in care, clinicians significantly drift from the original protocol because the processes, structure and elements of care frequently clash with clinician productivity and the shifting needs of the patient populations they serve. Clinicians in low resource settings like federally qualified health centers (FQHCs) report that while elements of EBPIs are important, their design is cumbersome, complex, overwhelming, inflexible, and minimize the nonspecific factors clinicians feel are crucial for quality delivery of care. In short, EBPIs demonstrate low usability (i.e., the extent to which a product can be used by specified users to achieve specified goals with effectiveness, efficiency, and satisfaction in a specified context of use. Although many implementation science (IS) frameworks do address the importance of EBPI characteristics, adapting and modifying EBPIs to enhance usability has not been a focus. User centered design (UCD) approaches, which have been successful in creating hardware and software tools that are accessible and compelling to use, have the potential to modify EBPIs so that they are accessible and compelling to clinicians. The investigators hypothesize that UCD-driven modifications to EBPI usability will result in enhanced clinician ability to deliver EBPI elements competently (target), and that better competence results in better patient-reported outcomes. The investigators will modify Problem-Solving Therapy for Primary Care (PST-PC) because it is the EBPI used in Collaborative Care (CC). To prepare for a larger trial to test hypotheses regarding the impact of EBPI usability on uptake, fidelity and competence, the aims of this R34 are: Aim 1: Discover Phase (3 months). Using iterative and participatory methods, the investigators will interview 10 clinicians from FHQCs affiliated with the Washington, Wyoming, Alaska, Montana and Idaho (WWAMI) region Practice Research Network (WPRN, a collaborative group of primary care practices to facilitate innovative community-based research), and observe the clinicians using PST-PC to identify usability challenges. Aim 2: Design/Build Phase (6 months) After identification of potential targets, the research team will work with the original 10 clinicians to engage in a rapid cycle of iterative prototype development and testing of PST-PC modifications. The build of these modifications will include the development of intervention prototypes for user testing and refinement with input from these care managers. Aim 3: Test Phase (15 months). The research team will test and compare the PST-PC modification (mPST-PC) to unmodified PST-PC in a small randomized clinical trial (RCT). Six newly identified clinicians will be randomized to the two conditions; each will see five patients for a total of 30 patients (15 in each arm) in the trial. H1: Modifications developed in the Design/Build phase for targets identified in the Discover Phase will result in better usability compared to traditional PST-PC. H2: Clinicians randomized to mPST-PC will certify faster, and will deliver PST elements more competently than clinicians randomized to PST-PC. H3: mPST-PC will be more effective than PST-PC on improving clinical outcomes of functional disability and change in depression symptoms over time.

Tracking Information

NCT #
NCT03514394
Collaborators
Not Provided
Investigators
Principal Investigator: Patricia Arean, PhD UWMC Psychiatry