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An Educational Intervention to Prevent Acute Kidney Injury in Primary Care. The ED-AKI-P Implementation Study (ED-AKI-P)

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acute kidney injury education
Sponsored by
University of Leicester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Kidney Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

All patients aged over 18 registered with the practice

Exclusion criteria:

Patients under the age of 18

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Educational Arm

    Arm Description

    This group will receive an acute kidney injury educational intervention

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    May 23, 2017
    Last Updated
    September 24, 2019
    Sponsor
    University of Leicester
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03165552
    Brief Title
    An Educational Intervention to Prevent Acute Kidney Injury in Primary Care. The ED-AKI-P Implementation Study
    Acronym
    ED-AKI-P
    Official Title
    An Educational Intervention to Prevent Acute Kidney Injury in Primary Care. The ED-AKI-P Implementation Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2015 (Actual)
    Primary Completion Date
    October 2018 (Actual)
    Study Completion Date
    October 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Leicester

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Kidney Injury

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Educational Arm
    Arm Type
    Experimental
    Arm Description
    This group will receive an acute kidney injury educational intervention
    Intervention Type
    Other
    Intervention Name(s)
    Acute kidney injury education
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Incidence of acute kidney injury before and after educational intervention
    Description
    The incidence of AKI in a group of practices will be measured before and after an educational intervention
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: All patients aged over 18 registered with the practice Exclusion criteria: Patients under the age of 18

    12. IPD Sharing Statement

    Learn more about this trial

    An Educational Intervention to Prevent Acute Kidney Injury in Primary Care. The ED-AKI-P Implementation Study

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