NCT07510373 Opioid Tapering After Hospital Discharge: Testing an Intervention to Improve Post-operative Opioid Prescribing
| NCT ID | NCT07510373 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Montefiore Medical Center |
| Condition | Opioid Tapering |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2026-04-12 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 42 participants in total. It began in 2026-04-12 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigator team proposes a randomized clinical trial (RCT) to test a discharge opioid taper support ("DOTS") intervention that is embedded in the providers' workflow in the EHR to prompt them to prescribe an opioid taper for patients after orthopedic surgery that is tailored to patients' expected analgesic needs. DOTS includes: 1) a recommendation for a patient-specific opioid taper schedule based on opioid use prior to discharge, 2) an automated discharge opioid prescription based on the recommended taper schedule that providers can override, 3) a patient facing handout and 4) post-discharge telephonic support for patients. Providers will be randomly assigned 1:1 to 2 groups and who will each be assigned to DOTS ("DOTS providers") or TS ("TS providers") in a step-wedge design. EHR data will be extracted and telephone surveys of 100 patients over 12 weeks will be conducted after hospital discharge. The two specific aims are: 1. To determine the effectiveness of DOTS for reducing excessive opioid prescribing after orthopedic surgery. Hypothesis 1: Patients discharged by DOTS providers will be prescribed a lower initial mean morphine equivalent daily dose (MMED), fewer opioid pills, and over 12 weeks, will have fewer subsequent opioid prescriptions and incident long-term opioid therapy, compared to patients discharged by non-DOTS providers. Hypothesis 2. Age and frailty will be moderators; DOTS will be more effective at reducing excessive prescribing to older (65 years and older) and frailer patients. 2. To determine the positive and negative impact of DOTS on patient outcomes. Hypothesis 3: Compared to patients of non-DOTS providers, patients of DOTS providers will have improved pain and function, fewer adverse events, and less emergency post-operative care. Hypothesis 4: Age and frailty will be moderators; DOTS will be more effective at improving positive and reducing negative outcomes in older and frailer patients.
Eligibility Criteria
Inclusion Criteria (Aim 1): * Age ≥ 18 years * Any orthopedic surgery during hospitalization * No pre-operative opioid use (no opioids in EHR in past 1 month) Exclusion Criteria (Aim 1): * Opioid Use Disorder \[by International Classification of Diseases, 10th revision (ICD-10), in past 6 months} * Cancer (by ICD-10, in past 6 months) * Receiving hospice care (by ICD-10, in past 6 months) Inclusion Criteria (Aim 2): * Meets criteria for inclusion in Aim 1 Exclusion Criteria (Aim 2): * Not fluent in English * Do not manage their own medications * Unable to provide consent over the phone * Orthopedic surgery due to cancer-related bone disease * No pre-operative opioid use (no opioids per New York state prescription drug monitoring program in past 1 month)
Contact & Investigator
Justina Groeger, MD
PRINCIPAL INVESTIGATOR
Montefiore Medical Center
Frequently Asked Questions
Who can join the NCT07510373 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Opioid Tapering. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07510373 currently recruiting?
Yes, NCT07510373 is actively recruiting participants. Contact the research team at jugroege@montefiore.org for enrollment information.
Where is the NCT07510373 trial being conducted?
This trial is being conducted at The Bronx, United States.
Who is sponsoring the NCT07510373 clinical trial?
NCT07510373 is sponsored by Montefiore Medical Center. The principal investigator is Justina Groeger, MD at Montefiore Medical Center. The trial plans to enroll 42 participants.