Participatory Design of Electronic Health Record Tools for Problem Solving Therapy

NCT03516513 | Completed Results

• 2 other identifiers: STUDY000042741P50MH115837-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 its 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 are deemed by many practitioners in other fields 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 support of patient engagement. We hypothesize that enhanced decision support (target mechanism) will sustain quality delivery of PST-PC, which in turn will improve patient reported outcomes.

Conditions

Depression

Outcome Measures

Primary Outcomes (3)

• Acceptability of Intervention Measure

  The Acceptability of Intervention Measure 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. Total scores depicted here are mean item scores and therefore the minimum and maximum values are 1 and 5. Higher scores mean more acceptable.

  Clinicians: Six months after certification in the intervention. Clients: Six week follow-up

• User Burden Scale

  The User Burden Scale is a 20-item scale that assesses user burden when working with a system or technology. Each item is rated on a 0-4 scale, with a maximum score of 80 (high burden) and minimum score of 0 (low burden).

  Clinicians: Six months follow-up after they have been certified in PST. Clients: six week follow-up timepoint

• System Usability Scale

  The System Usability Scale is a 10-item scale with each item ranked on a five point system of low to high usability. Items are ranked from 1=strongly disagree to 5=strongly agree. The scale score is calculated by adding the item scores and multiplying the total by 2.5, with 0 being the least and 100 being the maximum. A score of 68 or better is considered to be above average usability. As score less than 68 is considered to be poor usability. In this study, a score of 80 or more is considered our cut off for high usability.

  Clinicians: 6 month follow-up after certification in PST. Clients: Six week follow-up

Secondary Outcomes (3)

• Patient Health Questionnaire

  Baseline, 6 week follow-up

• Sheehan Disability Assessment Scale

  Baseline, 6 week follow up

• Problem Solving Therapy Clinician Certification

  Expert clinicians reviewed audiotapes of therapy sessions for each clinician participant over a six month period of time after initial training.

Study Arms (2)

Problem Solving Therapy as Usual

ACTIVE COMPARATOR

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

Assisted Problem Solving Therapy

EXPERIMENTAL

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

Interventions

Problem Solving Therapy as Usual BEHAVIORAL

Treatment as usual to deliver 6 weekly sessions to teach patients how to use the seven step process to solve problems.

Also known as: Problem Solving Therapy

Problem Solving Therapy as Usual

Assisted Problem Solving Therapy BEHAVIORAL

Smart note assisted delivery of 6 weekly session to teach patients how to use the seven step process to solve problems

Assisted Problem Solving Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinicians: 18 years of age, able to read and speak English, provides psychotherapy as part of the University of Washington Medicine network, and willing to video-record PST sessions with patient participants Clients: 18+ years of age, able to read and speak English, willing to receive psychotherapy from a clinician who is also participating in the study, willing to have therapy sessions video-recorded, Patient Health Questionnaire-9 score of 10 or higher

You may not qualify if:

• Client: History or presence of psychiatric diagnoses other than unipolar, non-psychotic depression or generalized anxiety disorder

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Behavioral Health Integration Program

Seattle, Washington, 98115, United States

Location

Related Publications (1)

• Lyon AR, Munson SA, Renn BN, Atkins DC, Pullmann MD, Friedman E, Arean PA. Use of Human-Centered Design to Improve Implementation of Evidence-Based Psychotherapies in Low-Resource Communities: Protocol for Studies Applying a Framework to Assess Usability . JMIR Res Protoc. 2019 Oct 9;8(10):e14990. doi: 10.2196/14990.

  PMID: 31599736 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Michael Pullmann
• Organization: University of Washington

pullmann@uw.edu

6158304563

Study Officials

• Ian Bennett, PhD

  UWMC Psychiatry

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research Assistants and expert raters will not be informed of condition therapists are assigned to.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine: Family Medicine

Model Details: Phase 1 will consist of qualitative interviews; Phase 2 will consist of rapid iterative design that includes qualitative interviews; Phase 3 will be an interventional pilot randomized trial. Data reported on ClinicalTrials.gov are for Phase 3.

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: May 4, 2018
• Study Start: January 30, 2020
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: August 13, 2024
• Results First Posted: August 13, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: This data will be available by June 31, 2024 for up to five years.
• Access Criteria: A request outlining the purpose of the data request, the length of time data will be stored before destruction, and the security protocol shall be sent to the study principal investigator for review.

Locations

US (1)