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Inpatient Multimodal Path to RecOVEry

NCT ID: NCT03303664

Last Updated: 2022-04-21

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-11

Study Completion Date

2018-02-26

Brief Summary

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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.

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Detailed Description

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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.

This intervention will be implemented throughout CHS hospitals, using a stepped wedge design to guide rollout. The initial pilot will be conducted in the trauma inpatient units at Carolinas Medical Center. All patients admitted to the two primary trauma units (11A and 11 Tower) during the pilot study period will be included in the evaluation.

Conditions

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Pain Opioid Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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IMPROVE Protocol

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.

Group Type EXPERIMENTAL

IMPROVE Protocol

Intervention Type OTHER

Comprehensive pain management protocol

Usual Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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IMPROVE Protocol

Comprehensive pain management protocol

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients not admitted to facility during the study period will be excluded from the analysis.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joseph R Hsu, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Carolinas Healthcare System - Stanly

Albemarle, North Carolina, United States

Site Status

Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

Carolinas Healthcare System - Mercy

Charlotte, North Carolina, United States

Site Status

Carolinas Healthcare System - Pineville

Charlotte, North Carolina, United States

Site Status

Carolinas Healthcare System - University

Charlotte, North Carolina, United States

Site Status

Carolinas Healthcare System - NorthEast

Concord, North Carolina, United States

Site Status

Carolinas Healthcare System - Kings Mountain

Kings Mountain, North Carolina, United States

Site Status

Carolinas Healthcare System - Lincoln

Lincolnton, North Carolina, United States

Site Status

Carolinas Healthcare System - Union

Monroe, North Carolina, United States

Site Status

Carolinas Healthcare System - Blue Ridge

Morganton, North Carolina, United States

Site Status

Carolinas Healthcare System - Cleveland

Shelby, North Carolina, United States

Site Status

Carolinas Healthcare System - Anson

Wadesboro, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00022455

Identifier Type: -

Identifier Source: org_study_id

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