Comparison · NCT04294901-sae
Intervention Group vs Historical Control Group: 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. Intervention Group vs Historical Control Group: serious adverse events. Trial comparisons, record NCT04294901-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04294901-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 | 0.00985 | 0.00668 | 0.0145 | wilson | |
| Risk in group 2 | 0.0103 | 0.00702 | 0.015 | wilson | |
| Risk difference, group 1 minus group 2 | -0.000422 | -0.00612 | 0.00525 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.959 | 0.555 | 1.66 | log | |
| Odds ratio, group 1 over group 2 | 0.958 | 0.552 | 1.66 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Intervention Group than on Historical Control Group | 2,370 | 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 | Intervention Group | Patients who received an EMPOWER brochure two weeks before their primary care appointment.~Direct to patient medication brochure: An EMPOWER medication brochure, adapted to the VA, designed to educate and activate patients. These brochures provide detailed medication information, allow self-testing of indications for use, prompt reflection of experiences with potential side effects, discuss alternative therapies (medication and non-pharmacologic options), and provide a vignette of a patient who successfully stopped the medicine. They were designed for a 6th grade reading level and were based upon theories of patient activation, adult learning, and cognitive dissonance. The visually appealing brochure repeatedly emphasizes that patients should not make any medication changes without first consulting their health care providers. | 25 | 2,539 | EG000 |
| Group 2 | Historical Control Group | The historical control cohort were seen by the same PCPs at the same sites as our intervention cohort from October 2019 to April 2020 (eighteen months to one year before the intervention timeframe).~The PPI group included adult patients of any age with an active prescription for any PPI with at least 90 consecutive days on the medication in the prior year, excluding diagnoses for which PPI continuation would be appropriate (e.g., Barrett's esophagus, or those prescribed chronic anti-inflammatory drugs associated with peptic ulcers).~The Gabapentin group included adult patients of any age with an active prescription of gabapentin \>1800mg/day with at least 90 consecutive days on the medication in the prior year, excluding patients with potential indications for use, including neuropathic pain, seizure disorders, and cancer-related pain.~The hypoglycemia-risk group included patients with diabetes based upon ICD-10-CM diagnosis codes, most recent HbA1c \<7%, as well as one or more of the following criteria: 1) age 65 years or older, 2) renal insufficiency defined as creatinine \>2 mg/dL, and/or 3) a diagnosis of cognitive impairment or prescription for an acetylcholinesterase inhibitor (e.g., donepezil). Patients in the hypoglycemia-risk group had an active prescription for insulin or sulfonylurea with at least 90 consecutive days on the medication in the prior year. | 26 | 2,532 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Potential medication-specific adverse drug withdrawal events (ADWEs) within 12 months after index date.
Source ClinicalTrials.gov
Trial
- Title
- Engaging Patients to Promote Deprescribing
- NCT number
- NCT04294901
- Phases
- NA
- Conditions
- Medical Overuse, Inappropriate Prescribing, Deprescriptions
- Interventions
- Direct to patient medication brochure
- Lead sponsor
- VA Office of Research and Development
- Results first posted
- 2025-05-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04294901?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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