Crossing InfectionsECONINCT03253640
Evaluation of Cost of Nosocomial Infection
An observational study of Crossing Infections and Drug Resistance, Microbial, run by Glasgow Caledonian University at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Crossing Infections, Drug Resistance, Microbial
- What is being tested?
- Exposure
- How many people
- 123 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Jun 2018to 31 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients admitted to study hospitals over night during a one year study period
Who may be able to join
- 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
- 18 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Hairmyres Hospital
East Kilbride
Edinburgh Royal Infirmary
Edinburgh
About this study
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
- Research Nurse administered questionnaire on recruitment quality of life questionnaire on recruitment
- Day before discharge quality of life questionnaire
- 1 month post discharge questionnaire
- 3 month post discharge questionnaire
- 6 month post discharge questionnaire
- 12 month post discharge questionnaire
- Record linkage - SMOR00, SMR01, PRISMA, District nursing
- 1,500-3,000 patients recruited for follow up.
- 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.
- Conditions
- Crossing Infections, Drug Resistance, Microbial
- Being tested
- Exposure
- Keywords
- Costs and Cost Analysis, Quality of Life, Length of Stay, Cohort study
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExposureOther
Healthcare associated infection (HAI)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During hospital stay, within one year post discharge for two hospital sites
Length of stay in hospital
Date of admission to discharge
Measured: 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
Measured: 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
Measured: Utility score during hospital stay for HAI and non_HAI patients during hospital stay, one month post discharge and three months post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start1 Jun 2018
- Primary completion30 Jun 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crossing InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glasgow Caledonian University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Strathclyde, Nick Graves Independent Consultant, NHS Lothian, NHS Lanarkshire
- Responsible party
- Sponsor
- Investigators
- Jacqui M Reilly, PhD, Study director, Glasgow Caledonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253640
- Sponsor's protocol ID
- 14-154
- Other IDs
- IRAS Identifier
- Acronym
- ECONI
- Status last verified
- Jan 2020
- First submitted
- 24 Feb 2017
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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.
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cost of Nosocomial Infection
- ClinicalTrials.gov ID
- NCT03253640
- Acronym / sponsor ID
- ECONI / 14-154
- Conditions
- Crossing Infections, Drug Resistance, Microbial
- Keywords
- Costs and Cost Analysis, Quality of Life, Length of Stay, Cohort study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Glasgow Caledonian UniversityUniversity, hospital or other
- Collaborators
- University of Strathclyde, Nick Graves Independent Consultant, NHS Lothian, NHS Lanarkshire
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 18 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Research Nurse administered questionnaire on recruitment quality of life questionnaire on recruitment
- Day before discharge quality of life questionnaire
- 1 month post discharge questionnaire
- 3 month post discharge questionnaire
- 6 month post discharge questionnaire
- 12 month post discharge questionnaire
- Record linkage - SMOR00, SMR01, PRISMA, District nursing
- 1,500-3,000 patients recruited for follow up.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with HAI during hospital stay | – | Other: ExposurePatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to study hospitals over night during a one year study period
Key inclusion criteria (6 listed)
- 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
- 18 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExposureHealthcare associated infection (HAI) | Other | Patients with HAI during hospital stay |
Primary outcome
Acquisition of healthcare associated infection
Time frame: During hospital stay, within one year post discharge for two hospital sites
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.
Length of stay in hospital
Time frame: All patient stays during the study year
Date of admission to discharge
Healthcare utilisation
Time frame: One year post discharge from hospital visit when recruited
Includes, specialty, antibiotic use, operations, post discharge health visits, community prescribing, out patient clinic attendance, re-admission to hospital
Quality of Life
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
Quality of life will be measured using SF-12 and EQ-5D validated questionnaires
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Derived from this study: PubMed 31221878Stewart 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqui M Reilly, PhD study director
Glasgow Caledonian University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crossing Infections and Drug Resistance, Microbial, run by Glasgow Caledonian University at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acquisition of healthcare associated infection (time frame: During hospital stay, within one year post discharge for two hospital sites). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03253640, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.