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Participatory Design of Electronic Health Record Tools for Problem Solving Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03516513
Recruitment Status : Recruiting
First Posted : May 4, 2018
Last Update Posted : April 28, 2021
Information provided by (Responsible Party):
Ian Bennett, University of Washington

Brief Summary:

Problem Solving Therapy for Primary Care (PST-PC) is an evidence based psychosocial intervention (EBPI) for use in primary care settings, with more than 100 clinical trials.

Despite it's proven efficacy we have found that implementation of PST-PC is complicated, resulting in rapid program drift (deviation from protocol with associated loss of efficacy), among practitioners following completion of training. Many studied have shown that program drift is not uncommon in the implementation of EBPIs and can be mitigated through on-going decision support and supervision. Unfortunately, decision support and supervisors of EBPIs are not widely available in low-resourced primary care clinics. We will address this problem by creating decision support tools to be integrated into electronic health records. Because these tools hare deemed by many practitioners in other field to be burdensome, we will explicitly involve active input on the content, design and function of these support tools. Outcomes may include electronic dashboards for panel management, automated suggestions for application of PST-PC elements based on patient reported outcomes or integration of automated patient tracking, and 4) support of patient engagement. We hypothesize that enhance decision support (target mechanism) will sustained quality delivery of PST-PC, which in turn will improve patient reported outcomes.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Problem Solving Therapy as Usual Behavioral: Assisted Problem Solving Therapy Not Applicable

Detailed Description:

SPECIFIC AIMS. Although evidence-based psychosocial interventions (EBPIs) are a preferred treatment option by vulnerable populations, they are rarely available in community primary care settings and when available, are often delivered with poor fidelity. High quality delivery of evidence-based psychosocial interventions (EBPIs) in primary care medicine is a function of many variables, including clinician training and usability of the intervention. Several studies find that for EBPIs to be delivered with sustained quality, on-going supervision and guidance is critical (this study's focus). While the availability of clinicians trained in EBPIs is scarce, the availability to supervisors trained in EBPIs is even more limited. Given the ubiquity of electronic health records, automated decision support tools and feedback systems have been found to be effective in supporting sustained quality EBPIs7, but in practice have had mixed success on outcomes such that they may actually hinder clinical care and are often ignored by clinicians.In a report by the Agency for Healthcare Research and Quality, a significant barrier to the use of decision support tools is that these tools have not been developed with input from the clinician or in consideration of their work environment. Using the Center's Discover, Design, Build, Test (DDBT) framework, we will work with clinicians from 13 Behavioral Health Integration Program (BHIP) sites to create a clinical decision tool that addresses the common decisional dilemmas clinicians face when implementing EBPIs. We hypothesize that creating tools to support EBPIs will result in improved clinician competency and sustained skill (target) to EBPIs, compared to clinicians without these supports, resulting in better patient outcomes . The specific aims of this study are: Aim 1: Discover Phase (6 months). Using Participant Action research (PAR) informed user-centered design methods we will interview clinicians in primary care about challenges they face in the delivery of two EBPIs, Behavioral Activation and Problem Solving Treatment, observe them delivering these EBPIs, and receiving feedback on cases from experts in these EBPIs. This process will help us to identify the common decisional dilemma's clinician's face in delivering EBPIs, their preferences for expert guidance strategies, and how decision support tools could be embedded into clinic workflow to reduce obstacles and enhance the delivery of EBPIs.

Aim 2: Design/Build Phase (6 months). Based on information obtained in the discover phase, we will engage in a rapid cycle iterative prototype development and testing of decision support tools to support PST-PC will be carried out using user-centered design (UCD). The build of these tools will include the development of prototypes for user testing and refinement with input from care managers across the 13 BHIP sites. Contribution to the Center. Data from this phase will be used to inform the Matrix of EBPI Modifications.

Aim 3: Test Phase (18 months) In the second to third year of the proposed project we will test the decision support tools in a small pilot trial with six providers and thirty patients randomized to the use of the decision support tools. H1: Clinicians with access to decision tools will report better acceptability, usability, and less burden when using BA and PST-PC than clinicians without the tools . H2: Clinicians randomized to decision support tools will more competently deliver EBPI elements than clinicians randomized to unsupported EBPI. H3: Patients treated by clinicians with access to decision tools will have better patient-reported outcomes than patients treated by clinicians without access to these tools as assessed with functional disability and change in depression symptoms over time .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase 1 will consist of qualitative interviews; Phase 2 will consist of rapid iterative design that includes qualitative interviews; Phase three will be a pilot randomized trial
Masking: Single (Outcomes Assessor)
Masking Description: Research Assistants and expert raters will not be informed of condition therapists are assigned to.
Primary Purpose: Health Services Research
Official Title: Participatory Design of Electronic Health Record Tools for Problem Solving Therapy
Actual Study Start Date : January 30, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Problem Solving Therapy as Usual

Clinicians in this arm of care will have access to the Case Management Tracking System which is already in use.

Intervention: unguided PST

Behavioral: Problem Solving Therapy as Usual
Treatment as usual to deliver 6 weekly sessions to teach patients how to use the seven step process to solve problems.
Other Name: Problem Solving Therapy

Experimental: Assisted Problem Solving Therapy

This arm will be designed and finalized in Phase 1 and 2 of the project. We anticipate that the intervention will leverage clinical notes required to be completed by clinicians and will provide information to clinicians to help patients improve over time, as well as help clinicians implement PST to high quality.

Intervention: guided PST

Behavioral: Assisted Problem Solving Therapy
Smart note assisted delivery of 6 weekly session to teach patients how to use the seven step process to solve problems

Primary Outcome Measures :
  1. Acceptability of Intervention Measure (AIM) [ Time Frame: Participants will rate their acceptability of PST six months after certification in the intervention. ]
    This is a four item measure of intervention acceptability, where each item is rated on a 1-5 scale, with 1 = not at all acceptable and 5 = very acceptable. each group will be compared on the degree they find the training they participated in acceptable after they complete training.

  2. User Burden Scale [ Time Frame: We will have participants complete this scale six months after they have been certified in PST ]
    The User Burden Scale is a 20-item scale that assesses six domains of user burden: use, physical burden, time/social burdens, mental/emotional burden, privacy concerns and financial burdens. The scale is calculated item measure of perceived burden of use that covers 6 domains: difficulty of use, emotional burden, physical burden, time and social burden, financial burden and privacy. Each item is rated on a 04- scale, with a maximum score of 80 (high burden) and minimum score of 0 (low burden). We will compare the ratings of educational burden between groups to determine if the new training

  3. System Usability Scale [ Time Frame: Participants in the will be asked to rate the usability of PST six months after they have been certified in PST. ]
    This is a 10-item scale with each item ranked on a five point system of low to high usability. The scale score is calculated by adding the item scores and multiplying by 2.5. A score of 68 or better is considered to be above average usability. As score less than 68 s considered to be poor usability. In this study, a score of 80 or more is considered our cut off for high usability. We will compare the two training programs on usability with this scale.

Secondary Outcome Measures :
  1. Patient Health Questionnaire [ Time Frame: Patient participants will be asked to complete this scale at the beginning of treatment and weekly for 6 weeks after they begin treatment. We will be comparing changes in depression over time between the two intervention groups. ]
    This is a 9 item self report measure of depression, where each item is rated on a scale of 0-3. Higher scores are indicative of more depressed mood, with scores over 10 considered to be clinically depressed.

  2. Sheehan Disability Assessment Scale [ Time Frame: Patient participants will be asked to complete this scale at the beginning of treatment and 6weeks after the first treatment session. We will compare groups on changes in disability over the 6 week period. ]
    4 item self report measure of functioning, where each item is ranked on a scale of 0-3, with 0 = no disability and 3 =high disability. Higher scores reflect great disability.

  3. PST Adherence Scale [ Time Frame: Expert clinicians will review 3 audiotapes of therapy sessions for each clinician participant over a six month period of time. We will look at changes in clinician competency over time and compare changes in competency between the two groups. ]
    This is an observer-rated, 20 item scale, with each scale raking therapist competency in delivering the seen steps of PST using a 0 (not competent) to 5 (expert level) scale. Higher scores reflect higher competency.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinicians must be providers in the UW neighborhood primary care clinics Patients must be depressed patients in the neighborhood primary care clinics who can speak English.

Exclusion Criteria:

  • Any clinician not in the UW system Any patient not part of the UW health system

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03516513

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Contact: Ian Bennett, MD 206-221-8692
Contact: Brenna Renn, PhD 2062218692

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United States, Washington
Behavioral Health Integration Program Recruiting
Seattle, Washington, United States, 98115
Contact: Ian Bennett, MD         
Sponsors and Collaborators
University of Washington
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Study Chair: Patricia Arean, PhD UWMC Psychiatry
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ian Bennett, Professor, School of Medicine: Family Medicine, University of Washington Identifier: NCT03516513    
Other Study ID Numbers: STUDY00004274
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Once data is collected and analyzed, we will make access to data available through the UW ALACRITY research portal. Any interested party may have access to the data
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: This data will be available by March 31, 2022.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Behavioral Symptoms