Safer opioid tapering after hospital discharge for orthopedic surgery patients

Opioid Tapering After Hospital Discharge: Testing an Intervention to Improve Post-operative

This trial will test an EHR-based program that prompts surgeons to write a patient-specific opioid taper, provides a take-home handout, and offers post-discharge phone support for adults after orthopedic surgery who were not taking opioids before surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Montefiore Medical Center (Academic / other)
• Locations: 1 site (The Bronx, New York)
• Trial ID: NCT07510373 on ClinicalTrials.gov

What this trial studies

Providers are randomized in a step-wedge design to receive a discharge opioid taper support (DOTS) workflow embedded in the EHR or usual telephonic support, with DOTS delivering a patient-specific taper recommendation, an automated discharge prescription that the provider can override, a patient handout, and post-discharge phone follow-up. The trial extracts EHR prescribing and clinical data and conducts telephone surveys of about 100 patients over 12 weeks after discharge to capture patient-reported outcomes and opioid use. Eligible patients are adults undergoing inpatient orthopedic surgery with no opioid prescriptions in the prior month, excluding those with recent opioid use disorder, cancer, or hospice care. The intervention is implemented at Montefiore Wakefield Campus and measures whether DOTS reduces excess opioid prescribing and leftover pills compared with usual practices.

Who should consider this trial

Good fit: Adults (≥18) having inpatient orthopedic surgery at the Montefiore Wakefield Campus who were not using prescription opioids in the month before surgery are the intended participants.

Not a fit: Patients with recent opioid use disorder, recent cancer care, on hospice, those who used opioids preoperatively, or who cannot manage medications or consent by phone (non-English speakers for Aim 2) are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, DOTS could reduce excess opioid prescriptions and leftover pills after surgery, lowering patients' risk of long-term opioid use and related harms.

How similar studies have performed: Prior work shows EHR prompts and standardized discharge prescriptions can reduce opioid quantities after surgery, but combining automated taper prescriptions with patient handouts and post-discharge phone support is a more novel, less extensively tested approach.

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)

Where this trial is running

The Bronx, New York

• Montefiore Wakefield Campus — The Bronx, New York, United States (Recruiting)

Study contacts

• Principal investigator: Justina Groeger, MD — Montefiore Medical Center
• Study coordinator: Justina Groeger, MD

Conditions Opioid Tapering; Post-operative opioid prescribing