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A Clinician-Focused Nudging Intervention to Optimize Post-Surgical Prescribing
NA trial testing Direct Feedback in Opioid Prescribing in 465 participants. Completed in 2 November 2023.
| Lead sponsor | Vanderbilt University Medical Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 465 |
| Start date | 1 December 2022 |
| Primary completion | 11 August 2023 |
| Estimated completion | 2 November 2023 |
| Sites | 1 location across United States |
Vanderbilt University Medical Center
18 and older, any sex, with Opioid Prescribing or Surgical Procedure, Unspecified. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Feasibility outcome: Percentage of surgeons approached who agree to participate in study
| Group | Value | 95% CI |
|---|---|---|
| Surgeon Recruitment | 47 |
Feasibility outcome: Percentage of patients contacted who agree to participate in study
| Group | Value | 95% CI |
|---|---|---|
| Phase 1 Patient Participants | 135 | |
| Phase 2 Patient Participants in the Direct Feedback Group | 27 | |
| Phase 2 Patient Participants in the No Direct Feedback Group | 31 |
Acceptability outcome: Surgeon-reported acceptability of intervention as measured by a "yes" response to the question "Would you find receiving such feedback on your patients' opioid consumption acceptable?"
| Group | Value | 95% CI |
|---|---|---|
| Direct Feedback | 5 | |
| No Direct Feedback | 4 |
Time frame: Adverse events were collected on patients who had surgery following the surgeon nudge intervention on Day 97. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Phase 2 Patient Participan… | Phase 2 Patient Participan… | Patients Who Underwent Sur… |
|---|---|---|---|---|
| Abdominal pain | Surgical and medical procedures | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — |
| Gastritis | Gastrointestinal disorders | — | — | — |
| Clostridioides difficile infection | Infections and infestations | — | — | — |
| Chest pain | Cardiac disorders | — | — | — |
| Reaction | System | Phase 2 Patient Participan… | Phase 2 Patient Participan… | Patients Who Underwent Sur… |
|---|---|---|---|---|
| Pain | General disorders | — | — | — |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | — | — | — |
| diverticulosis | Gastrointestinal disorders | — | — | — |
Most-reported serious reactions: Abdominal pain, Vomiting, Gastritis, Clostridioides difficile infection, Chest pain.
Data from ClinicalTrials.gov NCT05299528 adverse events section.
This is a pilot single site randomized controlled trial to assess the feasibility and acceptability of a nudging intervention providing surgeons with procedure-specific feedback regarding patients' postoperative opioid prescription-to-consumption ratio in individuals 18 years of age and older.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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