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NCT03303664 Clinical Trial

Inpatient Multimodal Path to RecOVEry

Pain Clinical Trial

— IMPROVE  

Official title:
Inpatient Multimodal Path to RecOVEry

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03303664
Other study ID # Pro00022455
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date July 11, 2017
Est. completion date February 26, 2018

Study information
Verified date February 2018
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date February 26, 2018
Est. primary completion date February 26, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• IMPROVE Protocol
Comprehensive pain management protocol

Locations
Country Name City State
United States Carolinas Healthcare System - Stanly Albemarle North Carolina
United States Carolinas Healthcare System - Mercy Charlotte North Carolina
United States Carolinas Healthcare System - Pineville Charlotte North Carolina
United States Carolinas Healthcare System - University Charlotte North Carolina
United States Carolinas Medical Center Charlotte North Carolina
United States Carolinas Healthcare System - NorthEast Concord North Carolina
United States Carolinas Healthcare System - Kings Mountain Kings Mountain North Carolina
United States Carolinas Healthcare System - Lincoln Lincolnton North Carolina
United States Carolinas Healthcare System - Union Monroe North Carolina
United States Carolinas Healthcare System - Blue Ridge Morganton North Carolina
United States Carolinas Healthcare System - Cleveland Shelby North Carolina
United States Carolinas Healthcare System - Anson Wadesboro North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Pain Average daily pain scores (VAS) Patient's entire length of stay in the hospital, up to 3 months
Secondary 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
Secondary Multimodal Therapy Percentage of patients receiving multimodal pain management Patient's entire length of stay in the hospital, up to 3 months
Secondary Average Daily MME Morphine Milligram Equivalent Dosing for Opioid Medications Patient's entire length of stay in the hospital, up to 3 months
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