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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Pain, Postoperative Vomiting and Nausea, Postoperative Complications, Mental Status Changes Postoperative

Intervention / Treatment
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* Other: Efficacy Safety Score
* Other: Verbal Numeric Rating Scale


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized trial
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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score, postoperative, pain, nausea, mental status, tool