DepressionNCT03516513
Participatory Design of Electronic Health Record Tools for Problem Solving Therapy
A study testing Problem Solving Therapy as Usual and Assisted Problem Solving Therapy in people with Depression, run by University of Washington at 1 site in United States.
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 its proven efficacy we have found that implementation of PST-PC is complicated, resulting in rapid program drift (deviation from protocol… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Problem Solving Therapy as Usual and Assisted Problem Solving Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2020to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Client: History or presence of psychiatric diagnoses other than unipolar, non-psychotic depression or generalized anxiety disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Behavioral Health Integration Program
Seattle, Washington, 98115
About this study
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.
Read the 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 EBPIs, 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, to 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. 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 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 .
- Conditions
- Depression
- Being tested
- Problem Solving Therapy as Usual, Assisted Problem Solving Therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem Solving Therapy as UsualBehavioural
Also called Problem Solving Therapy
Treatment as usual to deliver 6 weekly sessions to teach patients how to use the seven step process to solve problems.
Assisted Problem Solving TherapyBehavioural
Smart note assisted delivery of 6 weekly session to teach patients how to use the seven step process to solve problems
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Assisted Problem Solving Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: Clinicians: 6 month follow-up after certification in PST. Clients: Six week follow-up
Secondary outcomes (3)
Patient Health Questionnaire
The Patient Health Questionnaire is a 9 item self report measure of depression, where each item is rated on a scale of 0-3, for a total possible score of 0-27. Higher scores are indicative of more depressed mood, with scores over 10 considered to be clinically depressed.
Measured: Baseline, 6 week follow-up
Sheehan Disability Assessment Scale
The Sheehan Disability Assessment Scale is 3-item self report measure of functioning, where each item is ranked on a scale of 1-10, with 1 = no disability and 10 =high disability, for a total scale score ranging from 0 to 30. Higher scores reflect greater disability.
Measured: Baseline, 6 week follow up
Problem Solving Therapy Clinician Certification
Problem Solving Therapy Clinician Certification was determined using the Problem Solving Therapy Adherence Scale, an observer-rated, 11 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. Coders then use these item scores to rate a global fidelity rating on the same 0 to 5 scale. Receiving a 3 or higher on two sessions resulted in certification to practice PST. Therefore the outcome of importance is a dichotomous "certified/not certified". We report here on the number of clinicians in each group who certified.
Measured: Expert clinicians reviewed audiotapes of therapy sessions for each clinician participant over a six month period of time after initial training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start30 Jan 2020
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Ian Bennett, University of Washington
- Investigators
- Ian Bennett, PhD, Study chair, UWMC Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516513
- Sponsor's protocol ID
- STUDY00004274
- Other IDs
- 1P50MH115837-01
- Status last verified
- Jul 2024
- First submitted
- 28 Mar 2018
- Last updated
- 13 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once data is collected and analyzed, we will make access to data available upon outreach to the principal investigator. Any interested party may have access to the data upon reasonable request
Publications
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.
PubMed 31599736
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Participatory Design of Electronic Health Record Tools for Problem Solving Therapy
- ClinicalTrials.gov ID
- NCT03516513
- Acronym / sponsor ID
- STUDY00004274
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 4 May 2018 (actual)
- Results
- Posted 13 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 EBPIs, 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, to 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. 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 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 .
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Problem Solving Therapy as Usual | Active comparator | Behavioral: Problem Solving Therapy as UsualClinicians in this arm of care will have access to the Case Management Tracking System which is already in use. Intervention: unguided PST |
| Assisted Problem Solving Therapy | Experimental | Behavioral: Assisted Problem Solving TherapyThis 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Client: History or presence of psychiatric diagnoses other than unipolar, non-psychotic depression or generalized anxiety disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Problem Solving Therapy as UsualAlso: Problem Solving TherapyTreatment as usual to deliver 6 weekly sessions to teach patients how to use the seven step process to solve problems. | Behavioural | Problem Solving Therapy as Usual |
| Assisted Problem Solving TherapySmart note assisted delivery of 6 weekly session to teach patients how to use the seven step process to solve problems | Behavioural | Assisted Problem Solving Therapy |
Primary outcome
Acceptability of Intervention Measure
Time frame: Clinicians: Six months after certification in the intervention. Clients: Six week follow-up
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.
User Burden Scale
Time frame: Clinicians: Six months follow-up after they have been certified in PST. Clients: six week follow-up timepoint
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).
System Usability Scale
Time frame: Clinicians: 6 month follow-up after certification in PST. Clients: Six week follow-up
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.
3 secondary outcomes
Patient Health Questionnaire
Time frame: Baseline, 6 week follow-up
Sheehan Disability Assessment Scale
Time frame: Baseline, 6 week follow up
Problem Solving Therapy Clinician Certification
Time frame: Expert clinicians reviewed audiotapes of therapy sessions for each clinician participant over a six month period of time after initial training.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31599736Lyon 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.
- Individual participant dataSharing planned: Yes. Once data is collected and analyzed, we will make access to data available upon outreach to the principal investigator. Any interested party may have access to the data upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian Bennett, PhD study chair
UWMC Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem Solving Therapy as Usual and Assisted Problem Solving Therapy in people with Depression, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention Measure (time frame: Clinicians: Six months after certification in the intervention. Clients: Six week follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03516513, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.