- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03165552
An Educational Intervention to Prevent Acute Kidney Injury in Primary Care. The ED-AKI-P Implementation Study (ED-AKI-P)
September 24, 2019 updated by: University of Leicester
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
All patients aged over 18 registered with the practice
Exclusion criteria:
Patients under the age of 18
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Educational Arm
This group will receive an acute kidney injury educational intervention
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2015
Primary Completion (Actual)
October 1, 2018
Study Completion (Actual)
October 1, 2018
Study Registration Dates
First Submitted
May 23, 2017
First Submitted That Met QC Criteria
May 23, 2017
First Posted (Actual)
May 24, 2017
Study Record Updates
Last Update Posted (Actual)
September 26, 2019
Last Update Submitted That Met QC Criteria
September 24, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0524
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Kidney Injury
-
Instituto Nacional de Cardiologia Ignacio ChavezInstituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUnknownKidney Injury, Acute | Acute Renal Injury | Acute Kidney Injuries | Kidney Injuries, Acute | Acute Renal InjuriesMexico
-
Yonsei UniversityCompletedAcute Kidney Injury(Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery)Korea, Republic of
-
Hospital Civil de GuadalajaraNot yet recruitingAcute Kidney Disease | Acute Kidney Injury (AKI) | Acute Kidney Injuries
-
Sanliurfa Mehmet Akif Inan Education and Research...CompletedIn Acute Kidney InjuryTurkey (Türkiye)
-
University Hospital, GhentWithdrawn
-
Chang Gung Memorial HospitalConmed Pharmaceutical & Bio-Medical CorporationRecruitingAcute Kidney Disease | Acute Kidney Injury (AKI)Taiwan
-
Beni-Suef UniversityCairo UniversityRecruitingAKI - Acute Kidney InjuryEgypt
-
University Hospital MuensterBaxter Healthcare CorporationCompletedAcute Kidney Injury (AKI)Spain, France, United States, Turkey, Germany, Egypt, Italy, Libyan Arab Jamahiriya, Malta, North Macedonia, Palestinian Territory, occupied, Russian Federation, Saudi Arabia, Slovenia
-
Chinese PLA General HospitalBeijing Tsinghua Changgeng HospitalCompletedPostoperative Acute Kidney InjuryChina
-
Chinese PLA General HospitalCompletedPostoperative Acute Kidney InjuryChina
Clinical Trials on Acute kidney injury education
-
Ankara UniversityCompletedArthroplasty | Postoperative Acute Kidney InjuryTurkey
-
Kocaeli Derince Education and Research HospitalUnknown
-
Karolinska InstitutetBaxter Healthcare Corporation; Region StockholmCompleted
-
University Hospitals of Derby and Burton NHS Foundation...Completed
-
Qilu Hospital of Shandong UniversityCompletedAcute Kidney Injury | Aortic DissectionChina
-
Assiut UniversityNot yet recruiting
-
Geert Meyfroidt, MD, PhDCompletedCritical Illness | Acute Kidney InjuryBelgium
-
Taipei Medical UniversityTaipei Medical University WanFang HospitalCompletedAcute Kidney Injury | Machine Learning | Acute Kidney Disease | Chemotherapy Side EffectsTaiwan
-
Seoul National University HospitalUnknownNon-cardiac SurgeryKorea, Republic of
-
Nantes University HospitalRoche Pharma AG; ThermoFisher Scientific Brahms Biomarkers FranceCompleted