Electronically Recorded National Early Warning Scores, Pain Scores and PONV Scores Among Hospitalized Patients

Electronically Recorded National Early Warning Scores, Pain Scores and PONV Scores Among Hospitalized Patients and the Associated Patient Outcomes.

National early warning score (NEWS) enables early detection of patient deterioration in hospital floors. However, there is limited data on the prognostic value of NEWS among actual general ward patients. Further, there is no data on how changes in NEWS-values impact patient outcomes. Very little is known on how post-operative nausea and vomiting (PONV) and pain influences NEWS values and vital signs in general.

Study Overview

• Status: Active, not recruiting
• Conditions: Prevention of In-hospital Adverse Events

Detailed Description

The investigators aim to collect detailed data on patients' vital signs, NEWSs, pain scores and PONV scores through electronic data records, where these values are automatically stored with mobile mobile smart devices used by nursing staff. The expected volume of the cohort is 50,000 patients and 300,000 recordings of vital signs.

In addition to the scores and vital signs, the registry will include patients' identification numbers (IDs), dates and times of the recordings, and ward numbers. With the IDs, mortality data up to 90-days for the patients will be obtained from the national population register centre. All data will be handled in a pseudonymized form in a secure computer inside hospital, and approval to use the registry in study purposes will be obtained from the Ethics Committee of Tampere University Hospital.

• Study Type: Observational
• Enrollment (Actual): 30000

Contacts and Locations

Study Locations

• Finland
  • Pirkanmaa
    • Tampere, Pirkanmaa, Finland, 33520
      • Tampere University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult in-hospital patients in Pirkanmaa Hospital District whose vital signs have been recorded with mobile smart devices during the study period.

Description

Inclusion Criteria:

• Adult in-hospital patients with recordings of vital signs

Exclusion Criteria:

• Patients under 18 years

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death occurring within 90-days of the last NEWS measurement	The percentage of patients that die within 90-days of the last NEWS recording during their hospitalization.	90 days
Death occurring within one day after the first NEWS measurement on general wards	The percentage of patients that die within one day after their first NEWS measurement at the beginning of their general ward admission	One day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death occurring within 30-days of the last NEWS measurement	The percentage of patients that die within 30-days of the last NEWS recording during their hospitalization.	30 days
Death occurring within 2-30 days after the first NEWS measurement on general wards	The percentage of patients that die within 2-30 days after their first NEWS measurement at the beginning of their general ward admission	2-30 days
Incidence of post operative nausea and vomiting	Percentage of patients suffering from post-operative nausea and vomiting (recorded as a scale from 0 to 5) in the electronic patient records.	Up to 30 days after the first recording of patient's vital signs in the electronic patient records
Incidence of post operative pain	Percentage of patients suffering from post operative pain (recorded as numerical scale from 0 to 10) in the electronic patient records.	Up to 30 days after the first recording of patient's vital signs in the electronic patient records

Collaborators and Investigators

• Sponsor: Tampere University Hospital

Publications and helpful links

General Publications

• Loisa E, Kallonen A, Hoppu S, Tirkkonen J. Ability of the National Early Warning Score and its respiratory and haemodynamic subcomponents to predict short-term mortality on general wards: a prospective three-centre observational study in Finland. BMJ Open. 2022 Apr 26;12(4):e055752. doi: 10.1136/bmjopen-2021-055752.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 31, 2019
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: August 5, 2019
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 5, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: National early warning score; Prevention of serious adverse events; Patient deterioration
• Other Study ID Numbers: R20007R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to data security policies, individual participant data will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No