Acute Kidney InjuryED-AKI-PNCT03165552
An Educational Intervention to Prevent Acute Kidney Injury in Primary Care. The ED-AKI-P Implementation Study
A study testing Acute kidney injury education in people with Acute Kidney Injury, run by University of Leicester.
Trial summary
Patients with abnormal kidney function are common in primary care, particularly in people with other long standing illnesses. Some of these patients have long standing weakness of their kidneys, others develop new kidney weakness alongside other new illnesses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Acute kidney injury education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Oct 2018
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients aged over 18 registered with the practice
Who cannot join
- Patients under the age of 18
About this study
Patients with abnormal kidney function are common in primary care, particularly in people with other long standing illnesses. Some of these patients have long standing weakness of their kidneys, others develop new kidney weakness alongside other new illnesses. Patients with weak kidneys are more likely to be admitted to hospital, spend longer in hospital or die than those with normal kidneys. Although these events are common, how kidney weakness develops in the community is not well understood and awareness is poor. It is known that appropriate attention to a patient's medical care at times of high risk may reduce the onset of new kidney weakness. We have developed a new education package for primary healthcare professionals and patients. This will teach them about risks of new kidney weakness in their patients, give advice about how to combat them, and help prevent it occurring. This project will also use a new software tool - IMPAKT EVOLVE-AKI - to extract information from primary care systems and combine this with hospital data to identify developing kidney weakness much more accurately primary care . Both these elements of the study have already been tested in primary care and we are confident that they work well. Patients and the public have been involved in the development of these tools and will also be closely involved in their implementation. We now intend to implement the education more widely in primary care. We will then test how effectively the education has been implemented and whether it has a significant effect on the number of episodes of new kidney weakness developing in primary care. We calculate that we will need to provide this education to 36 practices to be able to determine accurately whether the programme significantly reduces new kidney weakness. Advice we have received from colleagues in primary care indicates that they are very interested in this education programme, and we believe that that a positive result from this study will lead to rapid and wide implementation of this combined programme of education and data analysis to the benefit of patients across the UK. This study fits well with a national programme of work in this area, and this combination will help with wider adoption of the study findings when the results are available.
Read the detailed description
Acute kidney injury (AKI) is a common cause of excess morbidity and mortality amongst patients with long term conditions, and is a common finding in patients admitted acutely into hospital. Although the disease commonly develops in the community there is little evidence to guide identification of patients at risk or how best to educate healthcare workers in primary care to improve the care of patients at risk of AKI. We hypothesise firstly that: an AKI educational intervention in primary care can be delivered to healthcare practitioners with high integrity, and secondly that: an AKI educational intervention delivered in primary care will result in a decreased incidence of AKI in the community. To test this we will build on pilot work that detects high-AKI risk patients and provides education for healthcare workers and at-risk patients. The study will bring together novel informatics, and education programme for primary healthcare workers along with patient information and guidance. Recruitment will be at the practice level and will take place after the delivery of the face to face educational intervention. Recruited practices will have their high risk AKI patients identified using web based software, and GPs will be encouraged, where clinically appropriate, to contact patients with an educational leaflet advising them how to prevent AKI by stopping medications under certain circumstances. In addition a variety of associated biomedical data will be obtained from practice IT systems to identify the preceding incidence of AKI in any recruited practice. Eighteen months after the delivery of the education intervention the incidence of AKI in each practice will again be determined to examine the effect of the educational intervention on AKI incidence. The fidelity of delivery of the education intervention will also be studied using qualitative techniques. Power calculations suggest that 36 practices will need to participate to detect a 25% reduction in AKI incidence. We anticipate that this programme will effectively reduce AKI community incidence and will be of significant interest to commissioners. Study findings will be disseminated through a variety of avenues including through structures established by NHS England to support improvements in AKI management.
- Conditions
- Acute Kidney Injury
- Being tested
- Acute kidney injury education
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute kidney injury educationOther
A face to face, a constructivist learning approach to encourage users to explore and learn about the topic of AKI in a way that maximises educational value. The programme is supported by a web based resource that presents a series of realistic case studies highlighting common causes of AKI in primary care designed to be easy to access and navigate, whilst being visual and interactive to enhance user engagement. The educayion is delivered to healthcare staff not to patients.
| Study group | Role | What they receive |
|---|---|---|
| Educational Arm | Experimental | This group will receive an acute kidney injury educational intervention Receives: Other: Acute kidney injury education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute kidney injury before and after educational intervention
The incidence of AKI in a group of practices will be measured before and after an educational intervention
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study startNov 2015
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165552
- Sponsor's protocol ID
- 0524
- Acronym
- ED-AKI-P
- Status last verified
- Sep 2019
- First submitted
- 23 May 2017
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Educational Intervention to Prevent Acute Kidney Injury in Primary Care. The ED-AKI-P Implementation Study
- ClinicalTrials.gov ID
- NCT03165552
- Acronym / sponsor ID
- ED-AKI-P / 0524
- Conditions
- Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 24 May 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.
Patients with abnormal kidney function are common in primary care, particularly in people with other long standing illnesses. Some of these patients have long standing weakness of their kidneys, others develop new kidney weakness alongside other new illnesses. Patients with weak kidneys are more likely to be admitted to hospital, spend longer in hospital or die than those with normal kidneys. Although these events are common, how kidney weakness develops in the community is not well understood and awareness is poor. It is known that appropriate attention to a patient's medical care at times of high risk may reduce the onset of new kidney weakness. We have developed a new education package for primary healthcare professionals and patients. This will teach them about risks of new kidney weakness in their patients, give advice about how to combat them, and help prevent it occurring. This project will also use a new software tool - IMPAKT EVOLVE-AKI - to extract information from primary care systems and combine this with hospital data to identify developing kidney weakness much more accurately primary care . Both these elements of the study have already been tested in primary care and we are confident that they work well. Patients and the public have been involved in the development of these tools and will also be closely involved in their implementation. We now intend to implement the education more widely in primary care. We will then test how effectively the education has been implemented and whether it has a significant effect on the number of episodes of new kidney weakness developing in primary care. We calculate that we will need to provide this education to 36 practices to be able to determine accurately whether the programme significantly reduces new kidney weakness. Advice we have received from colleagues in primary care indicates that they are very interested in this education programme, and we believe that that a positive result from this study will lead to rapid and wide implementation of this combined programme of education and data analysis to the benefit of patients across the UK. This study fits well with a national programme of work in this area, and this combination will help with wider adoption of the study findings when the results are available.
Detailed description
Acute kidney injury (AKI) is a common cause of excess morbidity and mortality amongst patients with long term conditions, and is a common finding in patients admitted acutely into hospital. Although the disease commonly develops in the community there is little evidence to guide identification of patients at risk or how best to educate healthcare workers in primary care to improve the care of patients at risk of AKI. We hypothesise firstly that: an AKI educational intervention in primary care can be delivered to healthcare practitioners with high integrity, and secondly that: an AKI educational intervention delivered in primary care will result in a decreased incidence of AKI in the community. To test this we will build on pilot work that detects high-AKI risk patients and provides education for healthcare workers and at-risk patients. The study will bring together novel informatics, and education programme for primary healthcare workers along with patient information and guidance. Recruitment will be at the practice level and will take place after the delivery of the face to face educational intervention. Recruited practices will have their high risk AKI patients identified using web based software, and GPs will be encouraged, where clinically appropriate, to contact patients with an educational leaflet advising them how to prevent AKI by stopping medications under certain circumstances. In addition a variety of associated biomedical data will be obtained from practice IT systems to identify the preceding incidence of AKI in any recruited practice. Eighteen months after the delivery of the education intervention the incidence of AKI in each practice will again be determined to examine the effect of the educational intervention on AKI incidence. The fidelity of delivery of the education intervention will also be studied using qualitative techniques. Power calculations suggest that 36 practices will need to participate to detect a 25% reduction in AKI incidence. We anticipate that this programme will effectively reduce AKI community incidence and will be of significant interest to commissioners. Study findings will be disseminated through a variety of avenues including through structures established by NHS England to support improvements in AKI management.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Educational Arm | Experimental | Other: Acute kidney injury educationThis group will receive an acute kidney injury educational intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients aged over 18 registered with the practice
Key exclusion criteria (1 listed)
- Patients under the age of 18
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 |
|---|---|---|
| Acute kidney injury educationA face to face, a constructivist learning approach to encourage users to explore and learn about the topic of AKI in a way that maximises educational value. The programme is supported by a web based resource that presents a series of realistic case studies highlighting common causes of AKI in primary care designed to be easy to access and navigate, whilst being visual and interactive to enhance user engagement. The educayion is delivered to healthcare staff not to patients. | Other | Educational Arm |
Primary outcome
Incidence of acute kidney injury before and after educational intervention
Time frame: 18 months
The incidence of AKI in a group of practices will be measured before and after an educational intervention
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 26 Sep 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Acute kidney injury education in people with Acute Kidney Injury, run by University of Leicester.
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 1 inclusion and 1 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 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of acute kidney injury before and after educational intervention (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2019.