Nudges for Opioid Reduction After Major Surgery Trial

Surgery Clinical Trial

— NORMS  

Official title:

Nudges for Opioid Reduction After Major Surgery

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04927351
• Other study ID #: STUDY00013382
• Secondary ID: 2T32DK070555-06
• Status: Suspended
• Phase: N/A
• Start date: November 17, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 484
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Less than 18 years of age

Related Conditions & MeSH terms

• Surgery

Intervention

Behavioral:
• Electronic Medical Record Based Discharge Medication Order Set
New medication discharge order set including recommended opioid quantities, adjunct pain medication

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Discharge Opioid Burden	Morphine milligram equivalents in the initial discharge prescription after index surgery	Immediately after study intervention
Secondary	Additional Opioid Burden within 30 days	Morphine milligram equivalents on any additional opioid prescription within 30 days of discharge	Within 30 Days
Secondary	Proportion of cases with Phone Calls to Surgery Department	Phone calls to surgery department within 30 days of discharge	Within 30 Days
Secondary	Proportion of Cases with Emergency Room Visits	ER visits within 30 days of discharge	Within 30 Days
Secondary	Proportion of Cases with Hospital Readmissions to a Surgical Service	Readmissions to surgical service within 30 days of discharge	Within 30 Days