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

September 8, 2023 updated by: Erlend Johan Skraastad, Vestre VikenHF Kongsberg Sykehus

Safety and Quality for Inpatients After Surgery at the Ward. Development and Evaluation of a New Tool: Efficacy Side-effect Score (ESS)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1152

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

  • Kazakhstan
      • Astana, Kazakhstan, 01005
        • Astana University Hospital, Astana
  • Russian Federation
      • Krasnodar, Russian Federation
        • Krasnodar University Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Efficacy Safety Score
Patients assessed using the ESS
Other: Efficacy Safety Score
Evaluation using the score for postoperative patients
Other Names:
  • ESS
Active Comparator: Verbal Numeric Rating Scale
Patients assessed using VNRS
Other: Verbal Numeric Rating Scale
Patients assessed for postoperative pain using VNRS (0-10)
Other Names:
  • VNRS
No Intervention: Control
Regular follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Hospital Stay (LOS)
Time Frame: 28 days
Assess LOS in groups of patients with different types of clinical data records an "all-out algorithms"
28 days

Collaborators and Investigators

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

Sponsor

Vestre VikenHF Kongsberg Sykehus

Collaborators

Norwegian Medical Association

Investigators

  • Principal Investigator: Vladimir Kuklin, Dr med, Vestre VIkenHF, Kongsberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

May 14, 2014

First Submitted That Met QC Criteria

May 16, 2014

First Posted (Estimated)

May 20, 2014

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VVHF-KS001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

On reasonable request

IPD Sharing Time Frame

After end of study

IPD Sharing Access Criteria

Contact PI, Vladimir Kuklin

IPD Sharing Supporting Information Type

  • SAP
  • ANALYTIC_CODE
  • CSR

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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