Condition category
Infections and Infestations
Date applied
10/04/2017
Date assigned
20/04/2017
Last edited
20/04/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Antibiotics kill bacteria, but don’t cure viral infections. When sick patients arrive at hospital, doctors have to work out whether they have a bacterial infection, viral infection, or another illness. This is difficult, because initial symptoms can be very similar (i.e. cough, temperature). Finding out exactly why a patient is sick takes a while, so it makes sense to give antibiotics initially. However, Department of Health guidance recommends stopping antibiotics when it becomes clear that they aren’t needed anymore. This could be because doctors work out that the patient never had a bacterial infection, or because they have got better. Stopping antibiotics when they aren’t needed reduces the chances of disease-causing and other gut bacteria becoming resistant to antibiotics. It is also important because antibiotics kill ‘friendly’ gut bacteria. But stopping antibiotics when they are no longer needed often doesn’t happen. Sometimes this is ‘just in case’ or thinking ‘better safe than sorry’, or because of the myth that antibiotic courses must be completed to avoid resistance. A package of strategies that can help healthcare professionals and patients stop taking antibiotics has been developed using internet-based training, standardised systems to review patients, regular support from pharmacists/infection specialists and material for patients. The aim of this study is to test a package of strategies developed specifically to help doctors, nurses, pharmacists and patients stop antibiotics in hospitals when they are no longer needed.

Who can participate?
NHS Trusts who admit patients to acute/general medicine and adults aged 18 and older who have received antibiotics in the hospital.

What does the study involve?
Participating trusts are randomly allocated to when they start the programme. They receive a package of strategies to help stop antibiotics in hospital when they are no longer needed. The package includes internet-based education, training, standard systems to help doctors review patients, regular support from pharmacists or infections specialists, and information for patients themselves. Data is collected within participating Trusts for patients who have been admitted to acute/general medicine. Mortality (death) and antibiotic use in patients admitted to general medicine before and after its introduction using data from electronic hospital records is compared from admission to 90 days later. In some Trusts, individual patients or carers, as well as healthcare professionals involved in the intervention, are invited to take part in a brief interview to find out what they thought about the intervention. Patients are also asked to complete a brief anonymous questionnaire (paper or online).

What are the possible benefits and risks of participating?
There are no direct benefits or risks with participating.

Where is the study run from?
This study is being run from the University of Oxford (UK) and takes place in NHS trusts (UK).

When is the study starting and how long is it expected to run for?
March 2016 to February 2021

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Miss Magda Laskawiec-Szkonter
magda.laskawiec@ouh.nhs.uk

Trial website

http://modmedmicro.nsms.ox.ac.uk/ark/

Contact information

Type

Public

Primary contact

Miss Magda Laskawiec-Szkonter

ORCID ID

Contact details

Oxford Respiratory Trials Unit
University of Oxford
Oxford Centre for Respiratory Medicine
Churchill Hospital
Oxford
OX3 7LE
United Kingdom
+44 1865 225205
magda.laskawiec@ouh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

33360

Study information

Scientific title

Antibiotic Review Kit for Hospitals (ARK-Hospital)

Acronym

Study hypothesis

The aim of this study is to test a package of strategies developed specifically to help doctors, nurses, pharmacists and patients stop antibiotics in hospital when they are no longer needed.

Ethics approval

South Central - Oxford C Research Ethics Committee, 16/03/2017, ref: 17/SC/0034

Study design

Randomised; Both; Design type: Process of Care, Psychological & Behavioural, Validation of investigation /therapeutic procedures

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Infectious diseases and microbiology, Primary sub-specialty: Other; UKCRC code/ Disease: Other/ General symptoms and signs

Intervention

This study consists of a behavioural intervention delivered to healthcare professionals involved in antibiotic prescribing or administration in adult inpatients admitted to acute/general medicine at different NHS Trusts. The intervention package includes internet-based education, training and standard systems to help doctors review patients, regular support from pharmacists or infections specialists, and materials for patients themselves.

First, the package is tested in one hospital to make sure that it is practical (‘feasibility study’). It is then implemented in one to three more hospitals, testing how many people use it and improving the package (‘internal pilot’). If specific criteria are met, the package is implemented in 36 hospitals in total (‘main trial’). The study compares mortality and antibiotic use in patients admitted to general medicine in each Trust before and after its introduction using data from electronic hospital records from admission to 90 days later. Each Trust therefore acts as its own control, with data from before intervention implementation compared to data after intervention implementation. Historical data from 1 April 2016 up until 12 months after the last Trust implements the intervention is used.

The ‘main trial’ uses a Trust (cluster)-randomised stepped-wedge design in which interventions are successively implemented across different Trusts over time. Randomisation is stratified by the calendar date on which the Trust joined the network (block size of 6). Each block is sequentially randomised (in order of block dates of joining the network) using computer-generated random numbers to a different target implementation date, initially over 2 month blocks (i.e. three Trusts implementing the intervention per month).

Individual patients are not be consented for this data collection. In some Trusts, individual patients or carers, as well as healthcare professionals involved in the intervention, are invited to take part in a brief interview to find out what they thought about the intervention. Patients are also asked to complete a brief anonymous questionnaire (paper or online).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Feasibility phase:
1. Acceptability of the intervention for healthcare professionals and patients are assessed through qualitative process evaluation at the end of the three month feasibility trial
2. Barriers to implementation are assessed through qualitative process evaluation at the end of the three month feasibility trial

Pilot phase:
Uptake of the online training component of the intervention is measured by the proportion of locally identified and prespecified essential individuals who complete the online training (recorded electronically) at three months of being invited to complete the training

Main trial:
1. Effect of introducing the intervention on the 30-day mortality post-admission is measured using death rates from hospital records at 30 days after admission to the acute/general medicine unit
2. Effect of introducing the intervention on the antibiotic exposure per acute/general medical admission is measured using the defined-daily-doses (DDD) of antibiotics per acute/general medical admission in the electronic hospital prescribing records at each admission and discharge

Secondary outcome measures

Pilot phase:
1. Uptake of the ARK 'review and revise' procedure within the intervention is measured using the proportion of regularly audited antibiotics prescriptions which document the ARK classification criteria at three months of being invited to complete the training.
2. Antibiotic exposure per acute/general medical admission before and after introducing the intervention is measured using the DDD of antibiotics per acute/general medical admission in the electronic hospital prescribing records at hospital admission and discharge

Main trial:
1. Effect of introducing the intervention on antibiotic exposure using different metrics i measured using the DDD per occupied bed-day, days on antibiotics per admission and bed day (length-of-therapy (LOT)), antibiotic days per admission and bed-day (days-of-therapy, DOT), carbapenem DDD, DOT and LOT per admission and per bed-day) at each admission and discharge.
2. Effect of introducing the intervention on adverse outcomes is measured using the ICU admission during current admission, total length-of-stay (hours), antibiotic restart after discontinuation, re-admission in the 30 days after discharge, C. difficile diarrhoea, mortality over the longer-term using repeated cross-sectional surveys at current admission, re-admissions, up to 30 days post-discharge and for 90 days post admission (for mortality)
3. Impact of the intervention on the fecal flora is measured using the proportion of discarded fecal samples from medical inpatients from which extended spectrum beta-lactamase (ESBL)-carrying Enterobacteriaceae can be isolated during hospital stay
4. Cost-effectiveness is measured using resource-utilisation and costs during hospital admission and 30 days post discharge
5. Uptake and acceptability of the online training component of intervention is measured using the proportion of locally identified and prespecified essential individuals who drive prescribing decisions for acute/general medical inpatients at the Trust who complete the online training (recorded electronically) within three months of the invitation to complete the training
6. Quantify uptake of the ARK 'review and revise' procedure within the intervention is measured using the proportion of regularly audited antibiotics prescriptions which document the ARK classification criteria within three months of the invitation to complete the training

Overall trial start date

01/03/2016

Overall trial end date

28/02/2021

Reason abandoned

Eligibility

Participant inclusion criteria

NHS Trusts:
1. Acute or district general NHS Trust admitting patients to acute/general medicine
2. Willing to implement the intervention in healthcare professionals involved in antibiotic prescribing or administration in adult acute/general medicine, and able to identify a local ‘champion’ to lead this
3. Able to provide the required routine electronic data on adult patients admitted to acute/general medicine over the required time periods

Participant level for patient/carer interviews that form part of the process evaluation:
1. Participant is willing and able to give informed consent for participation in the interview study
2. Male or female, aged 18 years or above
3. Admitted to acute/general medicine
4. Has received a course of antibiotic treatment started in hospital in the last 7-14 days
5. Either the patient themselves, or a close friend or family member who supported the patient during their inpatient stay and antibiotic treatment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 300; UK Sample Size: 300

Participant exclusion criteria

Not meeting inclusion criteria.

Recruitment start date

18/04/2017

Recruitment end date

01/09/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

Clinical Trials and Research Governance (University of Oxford)
Joint Research Office
Block 60
Churchill Hospital
Headington
Oxford
OX3 7LE
United Kingdom
+44 186 557 2228
ctrg@admin.ox.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing plan:
The datasets generated during and/or analysed during the current study are not expected to be made available because they are expected to include electronic health records data on over 500,000 individuals, and will remain the property of the participating Trusts.

Intention to publish date

01/03/2022

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes