NCT04927351

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
484

participants targeted

Target at P75+ for not_applicable surgery

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 16, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

November 17, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

July 8, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

June 4, 2021

Last Update Submit

July 3, 2024

Conditions

Surgery

Keywords

SurgeryDischargeHospital SystemsElectronic Medical RecordOpioidsPrescription

Outcome Measures

Primary Outcomes (1)

  • Total Discharge Opioid Burden

    Morphine milligram equivalents in the initial discharge prescription after index surgery

    Immediately after study intervention

Secondary Outcomes (4)

  • Additional Opioid Burden within 30 days

    Within 30 Days

  • Proportion of cases with Phone Calls to Surgery Department

    Within 30 Days

  • Proportion of Cases with Emergency Room Visits

    Within 30 Days

  • Proportion of Cases with Hospital Readmissions to a Surgical Service

    Within 30 Days

Study Arms (2)

Intervention

EXPERIMENTAL

New electronic medical record based discharge medication order set.

Behavioral: Electronic Medical Record Based Discharge Medication Order Set

Control

NO INTERVENTION

Usual Care

Interventions

Electronic Medical Record Based Discharge Medication Order SetBEHAVIORAL

New medication discharge order set including recommended opioid quantities, adjunct pain medication

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Less than 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

Location

Study Officials

  • David Flum, MD, MPH

    University of Washington

    STUDY DIRECTOR

  • Irene Zhang, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 2 arm parallel, cluster-randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

June 4, 2021

First Posted

June 16, 2021

Study Start

November 17, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2024

Last Updated

July 8, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)