NCT03303664

Brief Summary

The goal of the proposed study is to develop and implement a comprehensive strategy to address pain management in the inpatient setting while appropriately managing pain and optimizing patient safety in the inpatient setting. This strategy involves developing a new health Information Technology tool in the Omnicell and electronic medical record, implementing a "menu" of pain management and relaxation strategies, and developing educational materials for staff and patients to change the culture of pain management.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

12 active sites

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 11, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 16, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 6, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2018

Completed
Last Updated

April 21, 2022

Status Verified

February 1, 2018

Enrollment Period

8 months

First QC Date

August 16, 2017

Last Update Submit

April 19, 2022

Conditions

PainOpioid Use

Keywords

opioidinpatientpainmultimodal

Outcome Measures

Primary Outcomes (1)

  • Use of Opioid Overdose Reversal Treatment

    Incidence of administration of opioid reversal agent

    Patient's entire length of stay in the hospital, up to 3 months

Secondary Outcomes (4)

  • Pain

    Patient's entire length of stay in the hospital, up to 3 months

  • Oversedation without naloxone

    Patient's entire length of stay in the hospital, up to 3 months

  • Multimodal Therapy

    Patient's entire length of stay in the hospital, up to 3 months

  • Average Daily MME

    Patient's entire length of stay in the hospital, up to 3 months

Study Arms (2)

IMPROVE Protocol

EXPERIMENTAL

The intervention is composed of 4 parts: 1) a multidisciplinary team that recommends, develops, approves, monitors the components of the intervention and training? 2) monitoring of medication sedation risk using established scale 3) restriction of medication dispensing via enhanced technology 4) health professional training on multimodality pain management including complementary and alternative therapies.

Other: IMPROVE Protocol

Usual Care

NO INTERVENTION

Treatment of patients in the usual manner based on their diagnosis and resources available at that site.

Interventions

IMPROVE ProtocolOTHER

Comprehensive pain management protocol

IMPROVE Protocol

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients treated in facility as inpatient during the study period will be included in the analysis.

You may not qualify if:

  • Patients not admitted to facility during the study period will be excluded from the analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Carolinas Healthcare System - Stanly

Albemarle, North Carolina, 28001, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Carolinas Healthcare System - Mercy

Charlotte, North Carolina, 28207, United States

Location

Carolinas Healthcare System - Pineville

Charlotte, North Carolina, 28210, United States

Location

Carolinas Healthcare System - University

Charlotte, North Carolina, 28262, United States

Location

Carolinas Healthcare System - NorthEast

Concord, North Carolina, 28025, United States

Location

Carolinas Healthcare System - Kings Mountain

Kings Mountain, North Carolina, 28086, United States

Location

Carolinas Healthcare System - Lincoln

Lincolnton, North Carolina, 28092, United States

Location

Carolinas Healthcare System - Union

Monroe, North Carolina, 28112, United States

Location

Carolinas Healthcare System - Blue Ridge

Morganton, North Carolina, 28655, United States

Location

Carolinas Healthcare System - Cleveland

Shelby, North Carolina, 28150, United States

Location

Carolinas Healthcare System - Anson

Wadesboro, North Carolina, 28170, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joseph R Hsu, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2017

First Posted

October 6, 2017

Study Start

July 11, 2017

Primary Completion

February 26, 2018

Study Completion

February 26, 2018

Last Updated

April 21, 2022

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

No IPD will be made available to other researchers.

Locations

US(12)