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Efficacy Side-effect Score (ESS): Development and Evaluation of a New Tool for Patients After Surgery (ESScore)

Primary Purpose

Postoperative Pain, Postoperative Vomiting and Nausea, Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Efficacy Safety Score
Verbal Numeric Rating Scale
Sponsored by
Vestre VikenHF Kongsberg Sykehus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring score, postoperative, pain, nausea, mental status, tool

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All adult postoperative patients that are inpatients, and scheduled for hospitalization for more than 8 hours

Exclusion Criteria:

  • Children, mental illness, communication difficulties

Sites / Locations

  • Astana University Hospital, Astana
  • Krasnodar University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Efficacy Safety Score

Verbal Numeric Rating Scale

Control

Arm Description

Patients assessed using the ESS

Patients assessed using VNRS

Regular follow up

Outcomes

Primary Outcome Measures

Length of Hospital Stay (LOS)
Assess LOS in groups of patients with different types of clinical data records an "all-out algorithms"

Secondary Outcome Measures

Full Information

First Posted
May 14, 2014
Last Updated
September 8, 2023
Sponsor
Vestre VikenHF Kongsberg Sykehus
Collaborators
Norwegian Medical Association
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1. Study Identification

Unique Protocol Identification Number
NCT02143128
Brief Title
Efficacy Side-effect Score (ESS): Development and Evaluation of a New Tool for Patients After Surgery
Acronym
ESScore
Official Title
Safety and Quality for Inpatients After Surgery at the Ward. Development and Evaluation of a New Tool: Efficacy Side-effect Score (ESS)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vestre VikenHF Kongsberg Sykehus
Collaborators
Norwegian Medical Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
We hypothesized that better control of postoperative pain treatment and its side effects by monitoring ESS might influence the degree of mobility and morbidity in surgical patients and consequently reduce LOS. Thus, our aim was to validate the influence of recording ESS and the application of a "call-out algorithm" on LOS in two university hospitals in which the routine policy of registration of pain had not been adopted yet.
Detailed Description
Using clinical experience and consensus-methodology the investigators picked up and digitalized information about mental, postoperative nausea, vomiting and pain status at the rest and during mobilization in so called Efficacy Safety Score (ESS). Depending on expression of patient's complaints, all mentioned above clinical features are scored. We hypothesized that better control of postoperative pain treatment and its side effects by monitoring ESS might influence the degree of mobility and morbidity in surgical patients and consequently reduce length of hospital stay (LOS). Thus, our aim was to validate the influence of recording ESS and the application of a "call-out algorithm" on LOS in two university hospitals in which the routine policy of registration of pain had not been adopted yet. The primary endpoint of the study was to assess LOS in groups of patients with different types of clinical data records and "call-out algorithms," while secondary endpoints were to compare the degree of mobilization, number of postoperative nonsurgical complications, and 28-day survival between the groups.and summarized in the total score.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Postoperative Vomiting and Nausea, Postoperative Complications, Mental Status Changes Postoperative
Keywords
score, postoperative, pain, nausea, mental status, tool

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Efficacy Safety Score
Arm Type
Experimental
Arm Description
Patients assessed using the ESS
Arm Title
Verbal Numeric Rating Scale
Arm Type
Active Comparator
Arm Description
Patients assessed using VNRS
Arm Title
Control
Arm Type
No Intervention
Arm Description
Regular follow up
Intervention Type
Other
Intervention Name(s)
Efficacy Safety Score
Other Intervention Name(s)
ESS
Intervention Description
Evaluation using the score for postoperative patients
Intervention Type
Other
Intervention Name(s)
Verbal Numeric Rating Scale
Other Intervention Name(s)
VNRS
Intervention Description
Patients assessed for postoperative pain using VNRS (0-10)
Primary Outcome Measure Information:
Title
Length of Hospital Stay (LOS)
Description
Assess LOS in groups of patients with different types of clinical data records an "all-out algorithms"
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All adult postoperative patients that are inpatients, and scheduled for hospitalization for more than 8 hours Exclusion Criteria: Children, mental illness, communication difficulties
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir Kuklin, Dr med
Organizational Affiliation
Vestre VIkenHF, Kongsberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Astana University Hospital, Astana
City
Astana
ZIP/Postal Code
01005
Country
Kazakhstan
Facility Name
Krasnodar University Hospital
City
Krasnodar
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
On reasonable request
IPD Sharing Time Frame
After end of study
IPD Sharing Access Criteria
Contact PI, Vladimir Kuklin
IPD Sharing URL
https://doi.org/10.1155/2017/9431984
Citations:
PubMed Identifier
28855800
Citation
Dybvik L, Skraastad E, Yeltayeva A, Konkayev A, Musaeva T, Zabolotskikh I, Bjertnaes L, Dahl V, Raeder J, Kuklin V. Influence of a New "Call-Out Algorithm" for Management of Postoperative Pain and Its Side Effects on Length of Stay in Hospital: A Two-Centre Prospective Randomized Trial. Pain Res Manag. 2017;2017:9431984. doi: 10.1155/2017/9431984. Epub 2017 Aug 10.
Results Reference
derived

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Efficacy Side-effect Score (ESS): Development and Evaluation of a New Tool for Patients After Surgery

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