Trial Outcomes & Findings for Participatory Design of Electronic Health Record Tools for Problem Solving Therapy (NCT NCT03516513)
NCT ID: NCT03516513
Last Updated: 2024-08-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Clinicians: Six months after certification in the intervention. Clients: Six week follow-up
Results posted on
2024-08-13
Participant Flow
Participant milestones
| Measure |
Problem Solving Therapy as Usual Clinicians
Clinicians in this arm of care had access to the Case Management Tracking System which is already in use.
Intervention: unguided Problem Solving Therapy
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 Clinicians
Clinicians in this arm of care had access to a Case Management and Problem Solving Therapy digitally assisted system
Intervention: guided Problem Solving Therapy
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
|
Problem Solving Therapy as Usual Clients
Clients in this arm were served by clinicians in the Problem Solving Therapy as usual arm.
Problem Solving Therapy as Usual: Treatment as usual to receive 6 weekly sessions to learn how to use the seven step process to solve problems.
|
Assisted Problem Solving Therapy Clients
Clients in this arm were served by clinicians in the Problem Solving Therapy as usual arm.
Assisted Problem Solving Therapy: Smart note assisted delivery of 6 weekly session to learn how to use the seven step process to solve problems
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
7
|
4
|
9
|
|
Overall Study
COMPLETED
|
2
|
5
|
4
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Problem Solving Therapy as Usual Clinicians
Clinicians in this arm of care had access to the Case Management Tracking System which is already in use.
Intervention: unguided Problem Solving Therapy
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 Clinicians
Clinicians in this arm of care had access to a Case Management and Problem Solving Therapy digitally assisted system
Intervention: guided Problem Solving Therapy
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
|
Problem Solving Therapy as Usual Clients
Clients in this arm were served by clinicians in the Problem Solving Therapy as usual arm.
Problem Solving Therapy as Usual: Treatment as usual to receive 6 weekly sessions to learn how to use the seven step process to solve problems.
|
Assisted Problem Solving Therapy Clients
Clients in this arm were served by clinicians in the Problem Solving Therapy as usual arm.
Assisted Problem Solving Therapy: Smart note assisted delivery of 6 weekly session to learn how to use the seven step process to solve problems
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
0
|
0
|
Baseline Characteristics
Only clients completed outcome measures at baseline
Baseline characteristics by cohort
| Measure |
Problem Solving Therapy as Usual Clinicians
n=4 Participants
Clinicians in this arm of care had access to the Case Management Tracking System which is already in use.
Intervention: unguided Problem Solving Therapy
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 Clinicians
n=7 Participants
Clinicians in this arm of care had access to a Case Management and Problem Solving Therapy digitally assisted system
Intervention: guided Problem Solving Therapy
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
|
Problem Solving Therapy as Usual Clients
n=4 Participants
Clients in this arm were served by clinicians in the Problem Solving Therapy as usual arm.
Problem Solving Therapy as Usual: Treatment as usual to receive 6 weekly sessions to learn how to use the seven step process to solve problems.
|
Assisted Problem Solving Therapy Clients
n=9 Participants
Clients in this arm were served by clinicians in the Problem Solving Therapy as usual arm.
Assisted Problem Solving Therapy: Smart note assisted delivery of 6 weekly session to learn how to use the seven step process to solve problems
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35.5 years
STANDARD_DEVIATION 6.81 • n=4 Participants
|
47.0 years
STANDARD_DEVIATION 15.1 • n=7 Participants
|
56.5 years
STANDARD_DEVIATION 22.4 • n=4 Participants
|
34.4 years
STANDARD_DEVIATION 10.6 • n=9 Participants
|
41.9 years
STANDARD_DEVIATION 15.8 • n=24 Participants
|
|
Sex/Gender, Customized
Gender · Man
|
0 Participants
n=4 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=9 Participants
|
7 Participants
n=24 Participants
|
|
Sex/Gender, Customized
Gender · Woman
|
4 Participants
n=4 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=9 Participants
|
16 Participants
n=24 Participants
|
|
Sex/Gender, Customized
Gender · Agender
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=4 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
3 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=4 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=9 Participants
|
21 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=9 Participants
|
4 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=4 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=9 Participants
|
14 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=9 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=4 Participants
|
7 participants
n=7 Participants
|
4 participants
n=4 Participants
|
9 participants
n=9 Participants
|
24 participants
n=24 Participants
|
|
Patient Health Questionnaire
|
—
|
—
|
17.25 score on a scale
STANDARD_DEVIATION 5.5 • n=4 Participants • Only clients completed outcome measures at baseline
|
15.78 score on a scale
STANDARD_DEVIATION 4.68 • n=9 Participants • Only clients completed outcome measures at baseline
|
16.23 score on a scale
STANDARD_DEVIATION 4.76 • n=13 Participants • Only clients completed outcome measures at baseline
|
|
Sheehan Disability Assessment Scale
|
—
|
—
|
17.25 score on a scale
STANDARD_DEVIATION 5.12 • n=4 Participants • Only clients completed outcome measures at baseline.
|
20.33 score on a scale
STANDARD_DEVIATION 5.12 • n=9 Participants • Only clients completed outcome measures at baseline.
|
19.38 score on a scale
STANDARD_DEVIATION 5.12 • n=13 Participants • Only clients completed outcome measures at baseline.
|
PRIMARY outcome
Timeframe: Clinicians: Six months after certification in the intervention. Clients: Six week follow-upPopulation: All participants with baseline data
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.
Outcome measures
| Measure |
Problem Solving Therapy as Usual Clinicians
n=2 Participants
Clinicians in this arm of care had access to the Case Management Tracking System which is already in use.
Intervention: unguided Problem Solving Therapy
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 Clinicians
n=5 Participants
Clinicians in this arm of care had access to a Case Management and Problem Solving Therapy digitally assisted system
Intervention: guided Problem Solving Therapy
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
|
Problem Solving Therapy as Usual Clients
n=4 Participants
Clients in this arm were served by clinicians in the PST as usual arm.
Problem Solving Therapy as Usual: Treatment as usual to receive 6 weekly sessions to learn how to use the seven step process to solve problems.
|
Assisted Problem Solving Therapy Clients
n=9 Participants
Clients in this arm were served by clinicians in the PST as usual arm.
Assisted Problem Solving Therapy: Smart note assisted delivery of 6 weekly session to learn how to use the seven step process to solve problems
|
|---|---|---|---|---|
|
Acceptability of Intervention Measure
|
4.13 score on a scale
Standard Deviation .53
|
4.25 score on a scale
Standard Deviation 1.3
|
3.69 score on a scale
Standard Deviation 1.03
|
4.31 score on a scale
Standard Deviation .43
|
PRIMARY outcome
Timeframe: Clinicians: Six months follow-up after they have been certified in PST. Clients: six week follow-up timepointPopulation: All participants with follow-up timepoints
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).
Outcome measures
| Measure |
Problem Solving Therapy as Usual Clinicians
n=2 Participants
Clinicians in this arm of care had access to the Case Management Tracking System which is already in use.
Intervention: unguided Problem Solving Therapy
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 Clinicians
n=5 Participants
Clinicians in this arm of care had access to a Case Management and Problem Solving Therapy digitally assisted system
Intervention: guided Problem Solving Therapy
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
|
Problem Solving Therapy as Usual Clients
n=4 Participants
Clients in this arm were served by clinicians in the PST as usual arm.
Problem Solving Therapy as Usual: Treatment as usual to receive 6 weekly sessions to learn how to use the seven step process to solve problems.
|
Assisted Problem Solving Therapy Clients
n=9 Participants
Clients in this arm were served by clinicians in the PST as usual arm.
Assisted Problem Solving Therapy: Smart note assisted delivery of 6 weekly session to learn how to use the seven step process to solve problems
|
|---|---|---|---|---|
|
User Burden Scale
|
13.5 score on a scale
Standard Deviation .71
|
5.8 score on a scale
Standard Deviation 6.14
|
8.68 score on a scale
Standard Deviation 8.94
|
8.53 score on a scale
Standard Deviation 6.32
|
PRIMARY outcome
Timeframe: Clinicians: 6 month follow-up after certification in PST. Clients: Six week follow-upPopulation: All participants with follow-up data, and only those who experienced PST-Aid (therefore, "as usual" participants were not administered the measure.
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.
Outcome measures
| Measure |
Problem Solving Therapy as Usual Clinicians
Clinicians in this arm of care had access to the Case Management Tracking System which is already in use.
Intervention: unguided Problem Solving Therapy
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 Clinicians
n=5 Participants
Clinicians in this arm of care had access to a Case Management and Problem Solving Therapy digitally assisted system
Intervention: guided Problem Solving Therapy
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
|
Problem Solving Therapy as Usual Clients
Clients in this arm were served by clinicians in the PST as usual arm.
Problem Solving Therapy as Usual: Treatment as usual to receive 6 weekly sessions to learn how to use the seven step process to solve problems.
|
Assisted Problem Solving Therapy Clients
n=9 Participants
Clients in this arm were served by clinicians in the PST as usual arm.
Assisted Problem Solving Therapy: Smart note assisted delivery of 6 weekly session to learn how to use the seven step process to solve problems
|
|---|---|---|---|---|
|
System Usability Scale
|
—
|
75.5 score on a scale
Standard Deviation 72.5
|
—
|
66.25 score on a scale
Standard Deviation 68.8
|
SECONDARY outcome
Timeframe: Baseline, 6 week follow-upPopulation: Participants included all clients who reported data at follow-up. Clinicians did not complete this measure and therefore were not analyzed
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.
Outcome measures
| Measure |
Problem Solving Therapy as Usual Clinicians
Clinicians in this arm of care had access to the Case Management Tracking System which is already in use.
Intervention: unguided Problem Solving Therapy
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 Clinicians
Clinicians in this arm of care had access to a Case Management and Problem Solving Therapy digitally assisted system
Intervention: guided Problem Solving Therapy
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
|
Problem Solving Therapy as Usual Clients
n=4 Participants
Clients in this arm were served by clinicians in the PST as usual arm.
Problem Solving Therapy as Usual: Treatment as usual to receive 6 weekly sessions to learn how to use the seven step process to solve problems.
|
Assisted Problem Solving Therapy Clients
n=9 Participants
Clients in this arm were served by clinicians in the PST as usual arm.
Assisted Problem Solving Therapy: Smart note assisted delivery of 6 weekly session to learn how to use the seven step process to solve problems
|
|---|---|---|---|---|
|
Patient Health Questionnaire
|
—
|
—
|
13.75 score on a scale
Standard Deviation 2.99
|
10.33 score on a scale
Standard Deviation 4.69
|
SECONDARY outcome
Timeframe: Baseline, 6 week follow upPopulation: Analysis on all clients who completed measures at 6 week follow-up. Clinicians did not complete this measure and are not analyzed.
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.
Outcome measures
| Measure |
Problem Solving Therapy as Usual Clinicians
Clinicians in this arm of care had access to the Case Management Tracking System which is already in use.
Intervention: unguided Problem Solving Therapy
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 Clinicians
Clinicians in this arm of care had access to a Case Management and Problem Solving Therapy digitally assisted system
Intervention: guided Problem Solving Therapy
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
|
Problem Solving Therapy as Usual Clients
n=4 Participants
Clients in this arm were served by clinicians in the PST as usual arm.
Problem Solving Therapy as Usual: Treatment as usual to receive 6 weekly sessions to learn how to use the seven step process to solve problems.
|
Assisted Problem Solving Therapy Clients
n=9 Participants
Clients in this arm were served by clinicians in the PST as usual arm.
Assisted Problem Solving Therapy: Smart note assisted delivery of 6 weekly session to learn how to use the seven step process to solve problems
|
|---|---|---|---|---|
|
Sheehan Disability Assessment Scale
|
—
|
—
|
15.25 score on a scale
Standard Deviation 4.86
|
17.89 score on a scale
Standard Deviation 6.90
|
SECONDARY outcome
Timeframe: Expert clinicians reviewed audiotapes of therapy sessions for each clinician participant over a six month period of time after initial training.Population: Therapists who submitted audiotapes for review by expert coders. PST adherence was not conducted for clients.
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.
Outcome measures
| Measure |
Problem Solving Therapy as Usual Clinicians
n=3 Participants
Clinicians in this arm of care had access to the Case Management Tracking System which is already in use.
Intervention: unguided Problem Solving Therapy
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 Clinicians
n=5 Participants
Clinicians in this arm of care had access to a Case Management and Problem Solving Therapy digitally assisted system
Intervention: guided Problem Solving Therapy
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
|
Problem Solving Therapy as Usual Clients
Clients in this arm were served by clinicians in the PST as usual arm.
Problem Solving Therapy as Usual: Treatment as usual to receive 6 weekly sessions to learn how to use the seven step process to solve problems.
|
Assisted Problem Solving Therapy Clients
Clients in this arm were served by clinicians in the PST as usual arm.
Assisted Problem Solving Therapy: Smart note assisted delivery of 6 weekly session to learn how to use the seven step process to solve problems
|
|---|---|---|---|---|
|
Problem Solving Therapy Clinician Certification
|
1 Participants
|
5 Participants
|
—
|
—
|
Adverse Events
Problem Solving Therapy as Usual Clinicians
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Assisted Problem Solving Therapy Clinicians
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Problem Solving Therapy as Usual Clients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Assisted Problem Solving Therapy Clients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place