An Educational Intervention to Prevent Acute Kidney Injury in Primary Care. The ED-AKI-P Implementation Study (ED-AKI-P)
2019年9月24日 更新者: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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
28
段階
- 適用できない
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion criteria:
All patients aged over 18 registered with the practice
Exclusion criteria:
Patients under the age of 18
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:ヘルスサービス研究
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的: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.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of acute kidney injury before and after educational intervention
時間枠:18 months
|
The incidence of AKI in a group of practices will be measured before and after an educational intervention
|
18 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2015年11月1日
一次修了 (実際)
2018年10月1日
研究の完了 (実際)
2018年10月1日
試験登録日
最初に提出
2017年5月23日
QC基準を満たした最初の提出物
2017年5月23日
最初の投稿 (実際)
2017年5月24日
学習記録の更新
投稿された最後の更新 (実際)
2019年9月26日
QC基準を満たした最後の更新が送信されました
2019年9月24日
最終確認日
2019年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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