NCT03165552

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

2.9 years

First QC Date

May 23, 2017

Last Update Submit

September 24, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    18 months

Study Arms (1)

Educational Arm

EXPERIMENTAL

This group will receive an acute kidney injury educational intervention

Other: Acute kidney injury education

Interventions

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.

Educational Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients aged over 18 registered with the practice

You may not qualify if:

  • Patients under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2017

First Posted

May 24, 2017

Study Start

November 1, 2015

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

September 26, 2019

Record last verified: 2019-09