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WithdrawnNCT03303664IMPROVEUpdated Apr 21, 2022

Inpatient Multimodal Path to RecOVEry

An interventional study of IMPROVE Protocol in Pain and Opioid Use, sponsored by Wake Forest University Health Sciences. Withdrawn at 12 sites in United States. Per ClinicalTrials.gov, last updated 2022-04-21.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Health services research

Why this study was withdrawn
System-wide implementation of intervention prevented randomized trial design
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pain
  • Opioid Use

Keywords

  • opioid
  • inpatient
  • pain
  • multimodal
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients not admitted to facility during the study period will be excluded from the analysis.
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

  • No intervention
    Usual Care

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

Interventions

  • OtherIMPROVE Protocol

    Comprehensive pain management protocol

05

What researchers measure

Primary outcomes

  1. Use of Opioid Overdose Reversal Treatment

    Incidence of administration of opioid reversal agent

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

Secondary outcomes

  1. Pain

    Average daily pain scores (VAS)

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

  2. Oversedation without naloxone

    Incidence of patient oversedation (Pasero \> 2 or associated diagnosis code)

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

  3. Multimodal Therapy

    Percentage of patients receiving multimodal pain management

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

  4. Average Daily MME

    Morphine Milligram Equivalent Dosing for Opioid Medications

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

06

Study locations

12 sites
  • Carolinas Healthcare System - Stanly
    Albemarle, North Carolina 28001, United States
  • Carolinas Medical Center
    Charlotte, North Carolina 28203, United States
  • Carolinas Healthcare System - Mercy
    Charlotte, North Carolina 28207, United States
  • Carolinas Healthcare System - Pineville
    Charlotte, North Carolina 28210, United States
  • Carolinas Healthcare System - University
    Charlotte, North Carolina 28262, United States
  • Carolinas Healthcare System - NorthEast
    Concord, North Carolina 28025, United States
  • Carolinas Healthcare System - Kings Mountain
    Kings Mountain, North Carolina 28086, United States
  • Carolinas Healthcare System - Lincoln
    Lincolnton, North Carolina 28092, United States
  • Carolinas Healthcare System - Union
    Monroe, North Carolina 28112, United States
  • Carolinas Healthcare System - Blue Ridge
    Morganton, North Carolina 28655, United States
  • Carolinas Healthcare System - Cleveland
    Shelby, North Carolina 28150, United States
  • Carolinas Healthcare System - Anson
    Wadesboro, North Carolina 28170, United States
07

References and documents

Individual participant data

Plan to share: No — No IPD will be made available to other researchers.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03303664
Lead sponsor
Wake Forest University Health Sciences
Responsible party
Sponsor
First posted
Oct 6, 2017
Start date
Jul 11, 2017
Primary completion
Feb 26, 2018
Completion
Feb 26, 2018
Last update
Apr 21, 2022

Study contacts

Joseph R Hsu, MD
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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