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CompletedNCT03253640ECONIUpdated Feb 6, 2020

Evaluation of Cost of Nosocomial Infection

An observational study in Crossing Infections and Drug Resistance, Microbial, sponsored by Glasgow Caledonian University. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-06.

Sponsored by Glasgow Caledonian University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
123
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Healthcare associated infection (HAI) also known as Nosocomial Infection (NI) is costly to the NHS and distressing to patients. It leads to increased morbidity and mortality, increased length of stay and often requires additional treatments. Information on the impact in terms of additional cost of treatment, reduction in quality of life and cost to society is not fully described. This study will collect epidemiological and economic data on patients with and without HAI and develop a framework around which the cost effectiveness of a range of Infection Prevention and Control (IPC) interventions can be assessed.

The study will be delivered as 4 distinct but overlapping work Phases Phase 1 will describe the incidence of HAI (defined by ECDC case definitions) in an admission cohort. This phase is a surveillance project.

Phase 2: Will describe the impact of HAI on care in hospital -as many patients as possible who acquired HAI and twice as many non-HAI comparators will be recruited. Patients or their guardians or nearest relative will be told about the study and asked if they are willing to provide consent to complete a number of questionnaires. This phase will include case note review by ECONI research nurses and a patient questionnaire.

Phase 3: Will investigate the impact of HAI on patient care post discharge (use of Health and Social Care resources outside of Hospital), Quality of Life and personal expenses) - questionnaire to patients to ask about impact on their overall health and wellbeing and personal expenses. This will involve patients completing a paper questionnaire at one, three, six and twelve months after they have been discharged from hospital. This phase will include a nested qualitative study which will interview 20-30 patients who acquired HAI to further investigate the impact of HAI on their lives and livelihoods Phase 4: This phase will not involve any patient interaction. It will develop a framework to support modelling for decision making for future investment in Infection Prevention and Control (IPC) based on data collected within Phase one to three above. The information collected during the first three phases will be used to model possible outcomes of infection prevention and control measures. This will be a modelling exercise using data collected within Phase 1, 2 and 3 and the protocol for this work will be described elsewhere.

Phase 2 and 3 will be a cohort of as many patients as possible with HAI and a sample of non-HAI patients (twice the number of HAI patients) who consent to participate in the study within the year of recruitment.

Modes of data collection

  1. Research Nurse administered questionnaire on recruitment quality of life questionnaire on recruitment
  2. Day before discharge quality of life questionnaire
  3. 1 month post discharge questionnaire
  4. 3 month post discharge questionnaire
  5. 6 month post discharge questionnaire
  6. 12 month post discharge questionnaire
  7. Record linkage - SMOR00, SMR01, PRISMA, District nursing
  8. 1,500-3,000 patients recruited for follow up.
  9. All admissions to study hospitals for record linkage. Follow up duration 1 year post discharge from admission when patient was recruited.

Data will be collected using a Redcap database. Where possible controlled lists will be included within the database to ensure consistency of reporting. Validation visits to study sites will be undertaken throughout the study data collection period. Standard operating procedures will be developed for the ECONI team to use during recruitment and data collection. A data dictionary will be developed to record all data items recorded during the study, where these data were sourced, the choices available and the field-names within the data set. A publications and communication plan has been developed for the study and an analysis plan will be developed linking each of the objectives to a peer reviewed publication. A number of systematic reviews have be undertaken in the development of the ECONI study protocol.

02

Conditions studied

  • Crossing Infections
  • Drug Resistance, Microbial

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Keywords

  • Costs and Cost Analysis
  • Quality of Life
  • Length of Stay
  • Cohort study
03

In context

Cross Infection

285 studies on the registry are indexed under Cross Infection; 48 are open to participants now.

This study's enrollment of 123 is below the median of 351 across 115 observational studies indexed under Cross Infection.

Browse Cross Infection studies →

Lead sponsor

Glasgow Caledonian University is the lead sponsor of 46 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Admitted to hospital for an overnight stay at study hospital
  2. Subjects capable of giving , or if appropriate, subjects having an acceptable individual capable of giving consent on the subject's behalf
  3. Any sex
  4. 18 years old and over
  5. 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.
  6. Good English language skills (sufficient to read and understand the participant information sheet without help)

Exclusion criteria

Exclusion Criteria:

  1. Admitted to hospital as a day case
  2. Admitted to Hospitals other than the study hospitals
  3. Under 18 years
  4. Admitted to the study hospital during the study period and recruited to the study during a previous stay. See below
  5. Subjects not capable of giving unless legal representative or relative can provide proxy consent
  6. Patients who do not have English language skills to read and understand the information sheet without help
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
123 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherExposure

    Healthcare associated infection (HAI)

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. Length of stay in hospital

    Date of admission to discharge

    Time frame: All patient stays during the study year

  3. Healthcare utilisation

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

    Time frame: One year post discharge from hospital visit when recruited

  4. Quality of Life

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

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

07

Study locations

2 sites
  • Hairmyres Hospital
    East Kilbride, United Kingdom
  • Edinburgh Royal Infirmary
    Edinburgh, United Kingdom
08

References and documents

Publications

  • 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. PubMed 31221878 ↗

Individual participant data

Plan to share: Undecided — The study Steering Committee will review this at the end of the study. Data will be only be shared at an individual level if all identifiable information has been removed or categorised, individual records would be identified using a cypher code.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2018 to primary completion in Jun 2019, 12 months.

Of 56 non-industry observational studies under Cross Infection, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 65. This study's 12 months is below that.

Counting every sponsor, half of 56 studies reached it within 28 months; a quarter within 17 and three quarters within 65.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 24, 2017
First posted
Aug 18, 2017
StartActual
Jun 1, 2018
Primary completionActual
Jun 30, 2019
CompletionActual
Jan 31, 2020
Last update
Feb 6, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03253640
Lead sponsor
Glasgow Caledonian University
Collaborators
University of Strathclyde, Nick Graves Independent Consultant, NHS Lothian, NHS Lanarkshire
Responsible party
Sponsor
First posted
Aug 18, 2017
Start date
Jun 1, 2018
Primary completion
Jun 30, 2019
Completion
Jan 31, 2020
Last update
Feb 6, 2020

Study contacts

Jacqui M Reilly, PhD
study director · Glasgow Caledonian University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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