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

Vestre VikenHF Kongsberg Sykehus

Status: Completed

Conditions: Postoperative Complications; Postoperative Pain; Mental Status Changes Postoperative; Postoperative Vomiting and Nausea

Treatments: Other: Verbal Numeric Rating Scale; Other: Efficacy Safety Score

Study type: Interventional

Funder types: Other

Identifiers

NCT02143128

VVHF-KS001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,152 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,152 participants in 3 patient groups

Efficacy Safety Score

Experimental group

Description:

Patients assessed using the ESS

Treatment:

Other: Efficacy Safety Score

Verbal Numeric Rating Scale

Active Comparator group

Description:

Patients assessed using VNRS

Treatment:

Other: Verbal Numeric Rating Scale

Control

No Intervention group

Description:

Regular follow up