Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07510373

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

Led by Montefiore Medical Center · Updated on 2026-05-11

42

Participants Needed

1

Research Sites

102 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Underwent any orthopedic surgery during hospitalization
  • No opioid use in the past 1 month before surgery (per electronic health records)
Not Eligible

You will not qualify if you...

  • Opioid use disorder diagnosed in the past 6 months
  • Cancer diagnosis in the past 6 months
  • Receiving hospice care in the past 6 months
  • Not fluent in English
  • Do not manage own medications
  • Unable to provide consent over the phone
  • Orthopedic surgery due to cancer-related bone disease
  • Opioid use in the past 1 month before surgery (per state prescription monitoring)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Montefiore Wakefield Campus

The Bronx, New York, United States, 10466

Actively Recruiting

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Research Team

J

Justina Groeger, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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