Evaluation of Cost of Nosocomial Infection

NCT03253640 | Completed

• 2 other identifiers: 14-154IRAS Identifier
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 2

Brief Summary

This study will investigate the cost and impact of Healthcare Associated Infection (HAI) to patients, the health service and the wider community. This is in order to develop a model to allow policy makers to compare the cost effectiveness of Infection Prevention and Control measures in NHSScotland. The model will support policy makers and clinical teams in building a patient centred, safe, effective and efficient service.

Conditions

Crossing Infections; Drug Resistance, Microbial

Keywords

Costs and Cost Analysis; Quality of Life; Length of Stay; Cohort study

Outcome Measures

Primary Outcomes (4)

• Acquisition of healthcare associated infection

  Number of patients who develop new HAI Defined using ECDC HAI case definitions, and including costs of care in hospital, post discharge and impact of usual activity, ability to work and social care.

  During hospital stay, within one year post discharge for two hospital sites

• Length of stay in hospital

  Date of admission to discharge

  All patient stays during the study year

• Healthcare utilisation

  Includes, specialty, antibiotic use, operations, post discharge health visits, community prescribing, out patient clinic attendance, re-admission to hospital

  One year post discharge from hospital visit when recruited

• Quality of Life

  Quality of life will be measured using SF-12 and EQ-5D validated questionnaires

  Utility score during hospital stay for HAI and non_HAI patients during hospital stay, one month post discharge and three months post discharge

Study Arms (2)

Patients with HAI during hospital stay

Patients who meet the European Centre for Disease Control (ECDC) Healthcare Associated Infection (HAI) case definitions. Case note review will be undertaken during hospital stay. Questionnaire will be administered at recruitment, pre-discharge, one, three, six and twelve months post discharge.

Other: Exposure

Patients without HAI during hospital stay

Patients who do not meet the European Centre for Disease Control (ECDC) Healthcare Associated Infection (HAI) case definitions. Case note review will be undertaken during hospital stay. Questionnaire will be administered at recruitment, pre-discharge, one, three, six and twelve months post discharge.

Interventions

Exposure OTHER

Healthcare associated infection (HAI)

Patients with HAI during hospital stay

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to study hospitals over night during a one year study period

You may qualify if:

• Admitted to hospital for an overnight stay at study hospital
• Subjects capable of giving informed consent, or if appropriate, subjects having an acceptable individual capable of giving consent on the subject's behalf
• Any sex
• years old and over
• Patients without HAI will not be re-recruited into the study. Patients who have HAI on a subsequent admission will not be re-recruited but will be asked to complete a baseline data collection form (see below for discussion) NOTE: we do need to ensure this is clear within the ethics application.
• Good English language skills (sufficient to read and understand the participant information sheet without help)

You may not qualify if:

• Admitted to hospital as a day case
• Admitted to Hospitals other than the study hospitals
• Under 18 years
• Admitted to the study hospital during the study period and recruited to the study during a previous stay. See below
• Subjects not capable of giving informed consent unless legal representative or relative can provide proxy consent
• Patients who do not have English language skills to read and understand the information sheet without help

Sponsors & Collaborators

• Glasgow Caledonian University: lead
• University of Strathclyde: collaborator
• Nick Graves Independent Consultant: collaborator
• NHS Lothian: collaborator
• NHS Lanarkshire: collaborator

Study Sites (2)

Hairmyres Hospital

East Kilbride, United Kingdom

Location

Edinburgh Royal Infirmary

Edinburgh, United Kingdom

Location

Related Publications (1)

• Stewart S, Robertson C, Manoukian S, Haahr L, Mason H, McFarland A, Dancer S, Cook B, Reilly J, Graves N; ECONI Steering Committee. How do we evaluate the cost of nosocomial infection? The ECONI protocol: an incidence study with nested case-control evaluating cost and quality of life. BMJ Open. 2019 Jun 19;9(6):e026687. doi: 10.1136/bmjopen-2018-026687.

  PMID: 31221878 DERIVED

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jacqui M Reilly, PhD

  Glasgow Caledonian University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: August 18, 2017
• Study Start: June 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: January 31, 2020
• Last Updated: February 6, 2020

Record last verified: 2020-01

Locations

GB (2)