Comparison · NCT04907045-sae
Standard Implementation Plus Health Coaching vs Standard Implementation Plus Health Coaching and Practice Facilitation: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Standard Implementation Plus Health Coaching vs Standard Implementation Plus Health Coaching and Practice Facilitation: serious adverse events. Trial comparisons, record NCT04907045-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04907045-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 | 0.0000000000000000278 | 0.39 | wilson | |
| Risk in group 2 | 0 | 0 | 0.324 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.324 | 0.39 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
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 | Standard Implementation Plus Health Coaching | The clinic in this arm will implement reSET and reSET-O with a standard implementation strategy and patients at the clinic will receive support from a health coach to help them engage with reSET and reSET-O.~Health Coaching: The clinic is provided access to a health coach who conducts outreach with patients. The health coach facilitates engagement with the digital therapeutic and encourages contact with the care team.~Standard Implementation: Brief clinician training and an implementation toolkit consisting of job aids, patient educational materials, scripted conversations, electronic health record tools, and a population management workbench. | 0 | 6 | EG000 |
| Group 2 | Standard Implementation Plus Health Coaching and Practice Facilitation | The clinic in this arm will implement reSET and reSET-O with a standard implementation strategy and patients at the clinic will receive support from a health coach to help them engage with reSET and reSET-O. Additionally, a practice facilitator will provide the clinic with support for implementation.~Health Coaching: The clinic is provided access to a health coach who conducts outreach with patients. The health coach facilitates engagement with the digital therapeutic and encourages contact with the care team.~Practice Facilitation: In the context of a supportive relationship, a trained facilitator delivers the following interventions to clinic staff: Bolster Education, Audit and Provide Feedback, Support Plan-Do-Study-Act Cycles, Engage Others in Change.~Standard Implementation: Brief clinician training and an implementation toolkit consisting of job aids, patient educational materials, scripted conversations, electronic health record tools, and a population management workbench. | 0 | 8 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- An Initial Study of the Implementation of Digital Therapeutics for Substance Use Disorders in Primary Care
- NCT number
- NCT04907045
- Phases
- NA
- Conditions
- Drug Use Disorders, Illicit Drug Use, Alcohol-Related Disorders
- Interventions
- Health Coaching, Practice Facilitation, Standard Implementation
- Lead sponsor
- Kaiser Permanente
- Results first posted
- 2025-08-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04907045?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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