Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Enrollment |
Show adequate reach of enrollment using descriptive statistics showing 70% of eligible FEP participants, who are representative of the target population based on current program demographics, and 50% of their available family members, across the network were enrolled and complete baseline |
end of study, maximum of 5 years |
|
| Primary |
Colorado Symptom Index (CSI) - Symptom severity |
Efficacy of measurement-based care, comparing adjusted mean differences in baseline to 12-month change in psychotic symptom severity on the Colorado Symptom Index (CSI), between groups defined by clinician metrics from mHealth app assessed during this 12-month period. The CSI is a 14-item, self-report scale designed to assess frequency of positive mood and cognitive symptoms. Each item is scored on a 0-4 Likert-style scale and added together to give a score between 0 and 56, with higher scores indicating greater emotional distress. Reduction in score over time is considered clinical improvement. Maintenance of measurement-based care, based on adjusted mean differences in baseline to 24-month change in psychotic symptom severity between groups defined by clinician metrics from mHealth app aggregated over the 6-, 12- and 18-month assessment period, with the primary analysis based on a composite indicator for any endorsement of "impact on treatment plan" across these three periods. |
end of study, maximum of 5 years |
|
| Primary |
Provider use of data in care |
Compared to pre-implementation period, providers will report a change in the use of data to determine treatment choices after training and using the app for 6 months (Adoption). Adoption of data in care is measure by pre- and post-surveys of randomly sampled client sessions) |
end of study, maximum of 5 years |
|
| Primary |
Provider use of mHealth app |
Over 12 months, EP providers will use mHealth app in direct care to FEP clients for at least 50% of completed assessments (Implementation) as measured by metrics gathered in mHealth app. |
end of study, maximum of 5 years |
|
| Primary |
DUP tool reliability |
New DUP tool will show inter-rater reliability (IRR) between CSC providers and a MA-level assessor with an intra-class coefficient (ICC) of at least .80 for days from initial assessment to DUP start point, days from assessment to DUP end point, and days from start point to end point DUP (total DUP). |
end of study, maximum of 5 years |
|
| Primary |
DUP Tool convergent validity |
New DUP tool will show convergent validity, with ICCs of at least .80 between CSC providers and centralized study team assessors using the Symptom Onset in Schizophrenia Inventory (SOS) (reference standard). |
end of study, maximum of 5 years |
|
| Primary |
DUP Tool predictive validity - Functioning |
New DUP tool will show predictive validity, defined by significant relationships between shorter DUP and greater improvements in functioning (Global Social and Role Functioning scales) at 6 and 12 months - shown by regression coefficients between DUP and change from baseline to 6 and 12 months in functioning. |
end of study, maximum of 5 years |
|
| Primary |
DUP Tool predictive validity - Quality of Life |
New DUP tool will show predictive validity, defined by significant relationships between shorter DUP and greater improvements in quality of life (Lehman Quality of Life scale) at 6 and 12 months - shown by regression coefficients between DUP and change from baseline to 6 and 12 months in quality of life. |
end of study, maximum of 5 years |
|
| Primary |
DUP Tool feasibility and Acceptability |
Feasibility and acceptability to EP providers and clients, with a mean administration time of less than 40 minutes for the brief and full versions of the new DUP Tool |
end of study, maximum of 5 years |
|
| Secondary |
Satisfaction with care |
Patient rated satisfaction with EP care at end of study (Maintenance) as measured on the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item measurement that is designed to measure client satisfaction with services. Each item is scored on a 1-4 Likert-style scale and added together to give a score between 8 and 32, with higher scores indicating greater satisfaction with care. |
end of study, maximum of 5 years |
|
| Secondary |
Provider level factors |
Exploratory analysis will examine level of clinician expertise and training needed to effectively implement clinician review of FEP participant outcome data using MOBI at 80% of available time points (Adoption). |
end of study, maximum of 5 years |
|
