Nudges for Opioid Reduction After Major Surgery Trial (NORMS)

Nudges for Opioid Reduction After Major Surgery

This is a prospective pilot trial to evaluate a new electronic medical record based intervention to improve discharges after surgery. The investigators hypothesize that standard discharge medications after surgery will help to optimize opioid prescribing and potentially decrease healthcare utilization in the first 30 days after surgery.

Study Overview

• Status: Active, not recruiting
• Conditions: Surgery
• Intervention / Treatment: Behavioral: Electronic Medical Record Based Discharge Medication Order Set

Detailed Description

This is a 2-arm parallel randomized trial comparing a new electronic medical record (EMR)-based intervention to usual care after surgery. All patients will receive their usual peri- and intraoperative care. Then, upon discharge, their providers will see the new EMR-based discharge order set (intervention arm) or not (usual care). The investigators hypothesize that standard discharge medication order sets after surgery will help to optimize opioid prescribing and potentially decrease healthcare utilization in the first 30 days after surgery.

• Study Type: Interventional
• Enrollment (Actual): 484
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients
• Aged 18 and over
• Undergo selected general surgical procedures

Exclusion Criteria:

• Less than 18 years of age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Usual Care
Experimental: Intervention; New electronic medical record based discharge medication order set.	Behavioral: Electronic Medical Record Based Discharge Medication Order Set; New medication discharge order set including recommended opioid quantities, adjunct pain medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Discharge Opioid Burden	Morphine milligram equivalents in the initial discharge prescription after index surgery	Immediately after study intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional Opioid Burden within 30 days	Morphine milligram equivalents on any additional opioid prescription within 30 days of discharge	Within 30 Days
Proportion of cases with Phone Calls to Surgery Department	Phone calls to surgery department within 30 days of discharge	Within 30 Days
Proportion of Cases with Emergency Room Visits	ER visits within 30 days of discharge	Within 30 Days
Proportion of Cases with Hospital Readmissions to a Surgical Service	Readmissions to surgical service within 30 days of discharge	Within 30 Days

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Study Director: David Flum, MD, MPH, University of Washington; Principal Investigator: Irene Zhang, MD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2021
• Primary Completion (Actual): December 1, 2022
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 4, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (Actual): June 16, 2021

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Electronic Medical Record; Surgery; Prescription; Opioids; Discharge; Hospital Systems
• Other Study ID Numbers: STUDY00013382; 2T32DK070555-06 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No