- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03165552
An Educational Intervention to Prevent Acute Kidney Injury in Primary Care. The ED-AKI-P Implementation Study (ED-AKI-P)
24 settembre 2019 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
28
Fase
- Non applicabile
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion criteria:
All patients aged over 18 registered with the practice
Exclusion criteria:
Patients under the age of 18
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Incidence of acute kidney injury before and after educational intervention
Lasso di tempo: 18 months
|
The incidence of AKI in a group of practices will be measured before and after an educational intervention
|
18 months
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 novembre 2015
Completamento primario (Effettivo)
1 ottobre 2018
Completamento dello studio (Effettivo)
1 ottobre 2018
Date di iscrizione allo studio
Primo inviato
23 maggio 2017
Primo inviato che soddisfa i criteri di controllo qualità
23 maggio 2017
Primo Inserito (Effettivo)
24 maggio 2017
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
26 settembre 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
24 settembre 2019
Ultimo verificato
1 settembre 2019
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 0524
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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