Comparison · NCT02318797-sae
Patient Self-Directed Care vs Provider-Supported Integrated Care: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Patient Self-Directed Care vs Provider-Supported Integrated Care: serious adverse events. Trial comparisons, record NCT02318797-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02318797-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.00581 | 0.00198 | 0.017 | wilson | |
| Risk in group 2 | 0.00842 | 0.00386 | 0.0182 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0026 | -0.0131 | 0.00943 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.691 | 0.174 | 2.75 | log | |
| Odds ratio, group 1 over group 2 | 0.689 | 0.172 | 2.77 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Patient Self-Directed Care than on Provider-Supported Integrated Care | 384 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Patient Self-Directed Care | See intervention description~Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs | 3 | 516 | EG000 |
| Group 2 | Provider-Supported Integrated Care | See intervention description~Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education | 6 | 713 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Over the entire 2 year implementation and data collection period: October 2013 - January 2016
Source ClinicalTrials.gov
Trial
- Title
- Optimizing Behavioral Health Homes for Adults With Serious Mental Illness
- NCT number
- NCT02318797
- Phases
- NA
- Conditions
- Chronic Disease, Mental Health, Behavioral Health, Cardiovascular Disease, Diabetes Mellitus Type 2, Substance-related Disorders, Vascular Diseases
- Interventions
- Patient Self-Directed Care, Provider-Supported Integrated Care
- Lead sponsor
- University of Pittsburgh
- Results first posted
- 2018-02-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02318797?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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