Nudges for Opioid Reduction After Major Surgery Trial

NCT ID: NCT04927351

Last Updated: 2024-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

484 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-17

Study Completion Date

2024-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 arm parallel, cluster-randomized trial
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention

New electronic medical record based discharge medication order set.

Group Type EXPERIMENTAL

Electronic Medical Record Based Discharge Medication Order Set

Intervention Type BEHAVIORAL

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

Control

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Electronic Medical Record Based Discharge Medication Order Set

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Less than 18 years of age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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David Flum

Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Flum, MD, MPH

Role: STUDY_DIRECTOR

University of Washington

Irene Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2T32DK070555-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00013382

Identifier Type: -

Identifier Source: org_study_id

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