Participatory Design of Electronic Health Record Tools for Problem Solving Therapy

Depression Clinical Trial

Official title:

Participatory Design of Electronic Health Record Tools for Problem Solving Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03516513
• Other study ID #: STUDY00004274
• Secondary ID: 1P50MH115837-01
• Status: Completed
• Phase: N/A
• Start date: January 30, 2020
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Behavioral Health Integration Program	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of Intervention Measure (AIM)	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.	Participants will rate their acceptability of PST six months after certification in the intervention.
Primary	User Burden Scale	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	We will have participants complete this scale six months after they have been certified in PST
Primary	System Usability Scale	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.	Participants in the will be asked to rate the usability of PST six months after they have been certified in PST.
Secondary	Patient Health Questionnaire	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.	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.
Secondary	Sheehan Disability Assessment Scale	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.	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.
Secondary	PST Adherence Scale	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.	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.