A trial to determine the feasibility of embedding an ePrescribing-based Antimicrobial Stewardship (ePAMS+) intervention into existing ePrescribing systems within a hospital setting
| ISRCTN | ISRCTN13429325 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13429325 |
| IRAS number | 307085 |
| Secondary identifying numbers | CPMS 52225, RP-PG-0617-20009, IRAS 307085 |
- Submission date
- 10/03/2022
- Registration date
- 24/03/2022
- Last edited
- 21/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Antibiotics fight infections caused by bacteria, but not all infections are caused by bacteria. When patients first come to the hospital, often it is too early to be sure of what is causing their illness so doctors may prescribe antibiotics ‘just in case’. The more antibiotics a person takes the more likely they are to carry antibiotic-resistant bacteria in their body and to have antibiotic-resistant infections in the future. The ePAMS+ intervention is designed to manage antibiotic use within hospital settings by placing patients prescribed antibiotics on active review:
Under ePAMS+ the progress of a patient prescribed antibiotics will be reviewed in line with the national 'Start Smart - Then Focus' guidelines:
• Patients on review will have their antibiotics stopped if their doctors decide that their illness is not caused by bacteria
• When doctors have a patient's test results they can decide on how long they need antibiotics, and which ones they need
• Doctors may decide a patient will need to carry on with antibiotics because they are right for their illness
Who can participate?
No individual patients will be approached directly as part of this project. The national ‘Start Smart – Then Focus’ guidelines that all clinicians and hospitals should follow, underpins the ePAMS+ intervention. Although patient informed consent is not required or sought as part of this study, the implementation pack contains a resource (About Antibiotics – Information for Patients, Relatives and Carers) to help clinical staff explain antibiotic use and review to patients within participating clinical areas.
What does the study involve?
No individual patients will be approached directly as part of this project. This study will collect information on antibiotic use and prescribing behaviours in selected clinical areas at participating hospitals. Patients will be treated according to standard clinical care.
What are the possible benefits and risks of participating?
We do not anticipate that there will be any potential adverse effects or hazards associated with the research for any patients at participating hospitals or to staff using the intervention. There will be no direct benefit to patients or staff as a direct result of this study. However, the data will form part of the evidence base which will inform the care of other people who are prescribing antibiotics in the hospital setting.
Where is the study run from?
University of Edinburgh (UK)
When is the study starting and how long is it expected to run for?
March 2022 to April 2023
Who is funding the study?
National Institute for Health Research (NIHR) (UK).
Who is the main contact?
Dr Christopher Weir, ePAMS.trials@ed.ac.uk
Contact information
Public
Edinburgh Clinical Trials Unit
Usher Institute
University of Edinburgh
Level 2
Nine Edinburgh BioQuarter
9 Little France Road
Edinburgh
EH16 4UX
United Kingdom
 ORCID ID |
0000-0002-6494-4903 |
|---|---|
| Phone | +44 131 651 9928 |
| ePAMS.trials@ed.ac.uk |
Scientific
Usher Institute
University of Edinburgh
Old Medical School
Teviot Place
Edinburgh
EH8 9AG
United Kingdom
| ORCID ID |
0000-0001-7022-3056 |
|---|---|
| Phone | +44 131 650 8102 |
| Aziz.Sheikh@ed.ac.uk |
Study information
| Study design | Interventional non-randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | https://www.ed.ac.uk/usher/eprescribing-antimicrobial/the-programme |
| Scientific title | Complex ePrescribing-based Antimicrobial Stewardship intervention for Hospitals (ePAMS+) Feasibility Trial |
| Study acronym | ePAMS+ Feasibility |
| Study objectives | To assess the efficacy of the feasibility of implementing ePAMS+ within the existing ePrescribing Cerner systems at two NHS hospitals in England |
| Ethics approval(s) | Approved 16/03/2022, London South East Research Ethics Committee (Equinox House, City Link, Nottingham, NG2 4LA, UK; +44 2071048265; faye.slade@hra.nhs.uk), ref: 22/LO/0204 |
| Health condition(s) or problem(s) studied | Management of antibiotic use within hospital settings. |
| Intervention | Current interventions as of 02/11/2022: The ePAMS+ Feasibility trial to assess the feasibility of embedding the ePAMS+ intervention and extracting trial outcome measures using administrative data within selected hospital areas within two English NHS Trust organisations. Sites Two NHS Trust hospitals (Newcastle Teaching Hospitals NHS Foundation Trust and Royal Free London NHS Foundation Trust) have been selected to act as feasibility sites based on their use of Cerner e-Prescribing and Medication Administration (EPMA) systems. ePAMS+ Intervention The intervention has been developed to align with the national 'Start Smart — Then Focus' guidelines. It consists of the following tools embedded within the Cerner ePrescribing and Medicines Administration (EPMA) system: • Antibiotic Order Plans to help prescribe antibiotics and set up review and revise processes • Decision Aid to help communicate the original prescriber's level of certainty about the need for antibiotics (based on ARK intervention — add REF) • Information pages within the EPMA to help team get most from ePrescribing tools when used • Antibiotic Ward Task List to identify patients on antibiotics that may need review Duration ePAMS+ Feasibility trial will run until 31st December 2022, with data interpretation and analysis undertaken during the trial using regular data extracts. A checkpoint report for the funder will be submitted at the end of August 2022. If the ePAMS+ intervention is acceptable and feasible to implement, the main trial will be developed for implementation. Research Participants No individual patients will be approached directly as part of this project. The national 'Start Smart — Then Focus' guidelines that all clinicians and hospitals should follow, underpins the ePAMS+ intervention. Although patient informed consent is not required or sought as part of this study, the implementation pack contains a resource (Patient Information Leaflet) to help clinical staff explain antibiotic use and review to patients. Staff and patients within participating wards will be approached to participate in qualitative studies of acceptability and this is covered under the terms of an allied project (approved under IRAS ID: 259104). Unconsented, de-identified data relating to antibiotic prescribing and treatment with antibiotics within the selected clinical areas will be extracted from electronic medical prescribing systems by IT teams at participating hospitals • Data extracts will be processed at site by local IT teams to assign unique ePAMS+ IDs and to remove identifiers (i.e. date of birth, name, hospital numbers and NHS numbers. • De-identified data extracts will be transferred via secure protocol to the Scottish Safe Haven maintained by Public Health Scotland • Access to extracted and de-identified data will be granted by Public Health Scotland to named and trained members of the research team, with all outputs disclosure checked to ensure data confidentiality • Data transfer agreements will be put in place between participating NHS Trusts, Public Health Scotland and the Sponsor institution ____________________ Previous interventions: The ePAMS+ Feasibility trial to assess the feasibility of embedding the ePAMS+ intervention and extracting trial outcome measures using administrative data within selected hospital areas within two English NHS Trust organisations Sites Two NHS Trust hospitals (Newcastle Teaching Hospitals NHS Foundation Trust and Royal Free London NHS Foundation Trust) have been selected to act as feasibility sites based on their use of Cerner e-Prescribing and Medication Administration (EPMA) systems. ePAMS+ Intervention The intervention has been developed to align with the national 'Start Smart — Then Focus' guidelines. It consists of the following tools embedded within the Cerner ePrescribing and Medicines Administration (EPMA) system: • Antibiotic Order Plans to help prescribe antibiotics and set up review and revise processes • Decision Aid to help communicate the original prescriber's level of certainty about the need for antibiotics (based on ARK intervention — add REF) • Information pages within the EPMA to help team get most from ePrescribing tools when used • Antibiotic Ward Task List to identify patients on antibiotics that may need review Duration ePAMS+ Feasibility trial will run until 31st August 2022, with data interpretation and analysis undertaken during the trial using regular data extracts. A checkpoint report for the funder will be submitted at the end of August 2022. If the ePAMS+ intervention is acceptable and feasible to implement, the main trial will be developed for implementation. Research Participants No individual patients will be approached directly as part of this project. The national 'Start Smart — Then Focus' guidelines that all clinicians and hospitals should follow, underpins the ePAMS+ intervention. Although patient informed consent is not required or sought as part of this study, the implementation pack contains a resource (Patient Information Leaflet) to help clinical staff explain antibiotic use and review to patients. Staff and patients within participating wards will be approached to participate in qualitative studies of acceptability and this is covered under the terms of an allied project (approved under IRAS ID: 259104). Unconsented, de-identified data relating to antibiotic prescribing and treatment with antibiotics within the selected clinical areas will be extracted from electronic medical prescribing systems by IT teams at participating hospitals • Data extracts will be processed at site by local IT teams to assign unique ePAMS+ IDs and to remove identifiers (i.e. date of birth, name, hospital numbers and NHS numbers. • De-identified data extracts will be transferred via secure protocol to the Scottish Safe Haven maintained by Public Health Scotland • Access to extracted and de-identified data will be granted by Public Health Scotland to named and trained members of the research team, with all outputs disclosure checked to ensure data confidentiality • Data transfer agreements will be put in place between participating NHS Trusts, Public Health Scotland and the Sponsor institution |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Total antibiotic consumption measured as the number of defined daily doses (DDD), assessed overall and at site/ward level 2. Completeness of data extracted and whether standardised queries to capture data from Cerner systems are feasible/assessed via monthly data extracts 3. Assessment of the feasibility of measuring defined outcomes using extracted data |
| Secondary outcome measures | Mapping of critical decision points within Cerner systems to core principles of the intervention to develop fidelity index items, and determine how standardised queries to capture data from Cerner will enable coding of item response options (e.g. 'present', 'absent but should be present', 'not applicable') for automation of this coding structure for the cluster-randomised trial The following outcomes will be assessed for feasibility (added 16/05/2022): Length of hospital stay Days of therapy (and intravenous therapy) Diagnostics Number of antibiotics prescribed Number of antibiotic courses Repeat courses for same indication Number of courses for same indication Switches - of frequency - of dose - from intravenous to oral - from oral to intravenous - to alternative antimicrobial - from narrow to broad spectrum Discontinuation of therapy Number of courses concordant with local guidelines for antibiotic choice/duration Resistance rates Susceptibility Acquisition of multi-drug resistant organism Healthcare-associated infection Episodes of - Clostridium difficile infection (CDI) - methicillin- resistant Staphylococcus aureus (MRSA) - gram-negative bacilli (GNB) Added 01/11/2022: Site staff ePAMS+ training information will be captured on the Learning Management System to assess completion of training (i.e. professional discipline, date/time of module completion, time spent on learning and pre and post-test scores) |
| Overall study start date | 10/03/2022 |
| Completion date | 30/04/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 14 wards/clinical areas - 1958 admissions |
| Total final enrolment | 1768 |
| Key inclusion criteria | Medical records: 1. Adults >=16 years admitted to hospital as in-patients 2. Patients being treated with antibiotics (identified as Antibiotic Order Plans initiated and/or existing antibiotic use flagged within the electronic prescribing system) |
| Key exclusion criteria | Medical records: 1. Children <16 years |
| Date of first enrolment | 01/06/2022 |
| Date of final enrolment | 30/11/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Newcastle upon Tyne
TS1 4LP
United Kingdom
Sponsor information
University/education
Old College
South Bridge
Edinburgh
EH8 9YL
Scotland
United Kingdom
| Phone | +44 1312429261 |
|---|---|
| resgov@accord.scot | |
| Website | http://www.ed.ac.uk/home |
"ROR" |
https://ror.org/01nrxwf90 |
Funders
Funder type
Government
No information available
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/11/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal Added 09/08/2024: Planned publication in a high-impact peer-reviewed journal (currently in the second round of peer review) and a synopsis report to the funder, adding the PubMed and DOI links to this registry record. |
| IPD sharing plan | Current IPD sharing plan as of 21/10/2024: The qualitative datasets generated and/or analysed during the current study are not publicly available to protect the anonymity of participants, but are available from co-author Kathrin Cresswell on reasonable request. _____ Previous IPD sharing plan as of 08/03/2024: De-identified quantitative data for this trial are held within the Scottish National Safe Haven, having been obtained from routinely collected health data within the Cerner EPMA system. These data are not appropriate for public sharing, as consent was not sought from eligible admissions in this service-level evaluation of intervention feasibility. _____ Previous IPD sharing plan: All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 28/01/2023 | 30/01/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Statistical Analysis Plan | version 1.0 | 09/09/2022 | 11/03/2024 | No | No |
| Results article | 11/10/2024 | 17/10/2024 | Yes | No |
Additional files
Editorial Notes
21/10/2024: The participant level data sharing statement was changed.
17/10/2024: Publication reference added.
09/08/2024: The publication and dissemination plan was updated and the intention to publish date was changed from 31/07/2024 to 30/11/2024.
11/03/2024: The following changes were made to the study record:
1. Statistical analysis plan uploaded.
2. The target number of participants was changed from 10 wards/clinical areas to 14 wards/clinical areas.
3. Royal Victoria Infirmary was added to the study participating centres.
11/03/2024: The public contact was changed and the plain English summary was updated accordingly.
08/03/2024: The following changes were made:
1. The study participanting centre the Royal Free Hospital was removed.
2. The individual participant data (IPD) sharing plan and summary were changed.
3. The intention to publish date was changed from 31/08/2023 to 31/07/2024.
4. The target number of participants was changed from "10 wards/clinical areas" to "10 wards/clinical areas - 1958 admissions".
5. The total final enrolment was changed from 15 to 1768.
07/03/2023: The public contact was updated.
30/01/2023: Publication reference added.
13/12/2022: The overall trial end date was changed from 31/12/2022 to 30/04/2023.
07/12/2022: Total final enrolment added.
02/11/2022: The following changes were made to the trial record:
1. The public contact was changed and the plain English summary was updated accordingly.
2. The interventions have been changed.
2. The secondary outcome measures have been updated.
09/08/2022: The following changes were made to the trial record:
1. The public contact was changed.
2. The recruitment end date was changed from 31/08/2022 to 30/11/2022.
3. The overall end date was changed from 31/08/2022 to 31/12/2022.
4. The plain English summary was updated to reflect these changes.
16/05/2022: The following changes were made to the trial record:
1. The target number of participants was changed from "8 wards/clinical areas" to "10 wards/clinical areas".
2. The secondary outcome measures were changed.
05/05/2022: The recruitment start date has been changed from 01/05/2022 to 01/06/2022.
06/04/2022: The following changes have bee41330n made:
1. The recruitment start date has been changed from 01/04/2022 to 01/05/2022.
2. The ethics approval date has been added.
10/03/2022: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
