Inpatient Multimodal Path to RecOVEry (IMPROVE)

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• Status: Withdrawn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: Pain; Opioid Use
• Intervention / Treatment: Other: IMPROVE Protocol

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

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	Average daily pain scores (VAS)	Patient's entire length of stay in the hospital, up to 3 months
Oversedation without naloxone	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	Percentage of patients receiving multimodal pain management	Patient's entire length of stay in the hospital, up to 3 months
Average Daily MME	Morphine Milligram Equivalent Dosing for Opioid Medications	Patient's entire length of stay in the hospital, up to 3 months

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences

Study record dates

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: opioid; pain; inpatient; multimodal
• 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