Inpatient Multimodal Path to RecOVEry (IMPROVE)

April 19, 2022 updated by: Wake Forest University Health Sciences
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Albemarle, North Carolina, United States, 28001
        • Carolinas Healthcare System - Stanly
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center
      • Charlotte, North Carolina, United States, 28210
        • Carolinas Healthcare System - Pineville
      • Charlotte, North Carolina, United States, 28262
        • Carolinas Healthcare System - University
      • Charlotte, North Carolina, United States, 28207
        • Carolinas Healthcare System - Mercy
      • Concord, North Carolina, United States, 28025
        • Carolinas Healthcare System - NorthEast
      • Kings Mountain, North Carolina, United States, 28086
        • Carolinas Healthcare System - Kings Mountain
      • Lincolnton, North Carolina, United States, 28092
        • Carolinas Healthcare System - Lincoln
      • Monroe, North Carolina, United States, 28112
        • Carolinas Healthcare System - Union
      • Morganton, North Carolina, United States, 28655
        • Carolinas Healthcare System - Blue Ridge
      • Shelby, North Carolina, United States, 28150
        • Carolinas Healthcare System - Cleveland
      • Wadesboro, North Carolina, United States, 28170
        • Carolinas Healthcare System - Anson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Other: IMPROVE Protocol
Comprehensive pain management protocol
NO_INTERVENTION: Usual Care
Treatment of patients in the usual manner based on their diagnosis and resources available at that site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of Opioid Overdose Reversal Treatment
Time Frame: Patient's entire length of stay in the hospital, up to 3 months
Incidence of administration of opioid reversal agent
Patient's entire length of stay in the hospital, up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: Patient's entire length of stay in the hospital, up to 3 months
Average daily pain scores (VAS)
Patient's entire length of stay in the hospital, up to 3 months
Oversedation without naloxone
Time Frame: Patient's entire length of stay in the hospital, up to 3 months
Incidence of patient oversedation (Pasero > 2 or associated diagnosis code)
Patient's entire length of stay in the hospital, up to 3 months
Multimodal Therapy
Time Frame: Patient's entire length of stay in the hospital, up to 3 months
Percentage of patients receiving multimodal pain management
Patient's entire length of stay in the hospital, up to 3 months
Average Daily MME
Time Frame: Patient's entire length of stay in the hospital, up to 3 months
Morphine Milligram Equivalent Dosing for Opioid Medications
Patient's entire length of stay in the hospital, up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 11, 2017

Primary Completion (ACTUAL)

February 26, 2018

Study Completion (ACTUAL)

February 26, 2018

Study Registration Dates

First Submitted

August 16, 2017

First Submitted That Met QC Criteria

October 2, 2017

First Posted (ACTUAL)

October 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 21, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00022455

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD will be made available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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