Optimising the outputs of National Clinical Audits to support organisations to improve the quality of care and clinical outcomes

ISRCTN ISRCTN41584028
DOI https://doi.org/10.1186/ISRCTN41584028
Secondary identifying numbers TBC
Submission date
02/08/2017
Registration date
17/08/2017
Last edited
17/09/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Audit and feedback aims to improve patient care by comparing how healthcare is delivered against set standards. It is widely used by the NHS to work out how well they treat patients. NHS staff and organisations should remedy shortfalls found by audits. However, audits don't improve patient care as much as they should because organisations don’t always act on audit findings (i.e. feedback). The aim of this study is to identify better ways of giving feedback to improve the impact of audits on patient care. This will help to develop training and practical support for organisations to adopt these modifications when providing feedback.

Who can participate?
Clinicians and managers from provider and commissioner bodies targeted by national audit programmes

What does the study involve?
Participants are randomly allocated to look through different ways of presenting feedback. The feedback is hypothetical but based upon recent and real audit data. Reactions to feedback are then assessed by questions. This takes about 30 minutes. After submitting their responses, participants are able to see evidence-based tips on how to make feedback more effective which may be useful in their work.

What are the possible benefits and risks of participating?
No direct benefits to individual participants are expected although educational messages are embedded in the web content. No direct risks of participation are expected, other than time and inconvenience.

Where is the study run from?
University of Leeds (UK)

When is the study starting and how long is it expected to run for?
October 2017 to March 2020

Who is funding the study?
Health Services and Delivery Research Programme (UK)

Who is the main contact?
Prof. Robbie Foy

Contact information

Prof Robbie Foy
Public

Leeds Institute of Health Sciences
Level 10
Worsley Building
Clarendon Way
Leeds
LS2 9NL
United Kingdom

ORCiD logoORCID ID 0000-0003-0605-7713

Study information

Study designFractional factorial screening experiment
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Internet/virtual
Study typeOther
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleOptimising the outputs of National Clinical Audits to support organisations to improve the quality of care and clinical outcomes
Study objectivesThis study is part of a programme with the overall aim of improving patient care by optimising the content, format and delivery of feedback from national clinical audits.

The specific research questions for this study are:
1. Out of a set of recent, state-of-the-science, theory-informed recommendations for improving feedback, which are the most important and feasible to evaluate further within national audit programmes?
2. What is the effect of modifications to feedback on intended enactment, comprehension, engagement amongst clinicians and managers targeted by national audits, user experience and preferences under ‘virtual laboratory’ conditions?
Ethics approval(s)University of Leeds, School of Medicine Ethics Committee (SoMREC), 03/08/2017, ref: MREC16-180
Health condition(s) or problem(s) studiedNational Clinical Audits
InterventionThe intervention will be modifications to feedback which can be readily adopted by national audit programmes. A structured consensus process will guide selection of modifications for further development and specify strategies for tailoring these to the needs of specific stakeholder groups.

Participants will be randomised (stratified by audit and recipient type) to one combination of six online modifications, each a separate factor with two levels (presence/absence). A fraction of the full 26 factorial (=64 packages of modifications) will be chosen, ideally a quarter (=16 packages) but a half (=32 packages) if this would confound important effects when the modifications are known. The particular fraction of packages will be chosen to minimise complexity of the experiment and to avoid any packages that are felt to be infeasible or undesirable. The design will be as close to orthogonal as possible to minimise the sample size required to detect the main effect of each modification.

Feasibility testing will be undertaken with a sample of targeted participants and a prototype online survey to assess participant burden (perceived difficulty, time taken and completion) and reduce the number of modifications if necessary.

The trialists' experience of examining the receipt of feedback across different settings is that many recipients have or allocate only limited time to rapidly assess reports and decide whether or not to act. Similarly, for the online experiment, it is anticipated that participants will aim to complete their responses within limited time (e.g. around 30 minutes); the study will therefore effectively simulate the types of deeper, reflective and more superficial, reactive thinking processes that typically occur on receipt of feedback in service settings.
Intervention typeBehavioural
Primary outcome measureIntended enactment, i.e. plans to change behaviour, on a range of graded potential responses from general and non-committal through to specific commitments. Data collected via online questionnaires completed after exposure to feedback modifications
Secondary outcome measures1. Comprehension (understanding of feedback data)
2. User experience (ease of use)
3. Preferences
Data collected via an online questionnaire completed after exposure to feedback modifications

4. Length of time spent working through each modification
5. Participants' engagement with selected modifications (e.g. working through all levels of feedback presented for a ‘graded entry’ modification)
Collected using online data analytics during the intervention
Overall study start date01/10/2017
Completion date30/03/2020

Eligibility

Participant type(s)Health professional
Age groupAdult
SexBoth
Target number of participants500 participants from across the UK
Total final enrolment638
Key inclusion criteriaClinicians and managers from provider and commissioner bodies targeted by national audit programmes
Key exclusion criteriaClinicians and managers not linked to a targeted national audit programme
Date of first enrolment10/04/2019
Date of final enrolment18/10/2019

Locations

Countries of recruitment

  • United Kingdom

Study participating centre

National Audit Programmes
-
United Kingdom

Sponsor information

University of Leeds
University/education

Medicine and Health Faculty Office
Worsley Building
Leeds
LS2 9JT
England
United Kingdom

ROR logo "ROR" https://ror.org/024mrxd33

Funders

Funder type

Government

Health Services and Delivery Research Programme
Government organisation / National government
Alternative name(s)
Health Services and Delivery Research (HS&DR) Programme, NIHR Health Services and Delivery Research (HS&DR) Programme, NIHR Health Services and Delivery Research Programme, HS&DR Programme, HS&DR
Location
United Kingdom

Results and Publications

Intention to publish date30/03/2021
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planThe trialists will continue developing the collaboration between their research group and the Healthcare Quality Improvement Partnership (HQIP), the commissioner responsible for development and contract management of national clinical audits. Through this collaboration and conducting the proposed research, they will understand the strategic and operational considerations involved in supporting and guiding national audit programmes.

The trialists are part of an international network which seeks to improve the evidence base for and use of audit and feedback and will continue to use this network to build a cumulative science of audit and feedback. Network members include researchers and knowledge users from Canada, UK, Australia, and the United States.

The trialists will also hold national and international stakeholder meetings, and describe and report their findings through peer-reviewed journals, and national and international conferences.
IPD sharing planThe data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Funder report results 01/07/2021 04/03/2022 No No
Results article 26/05/2022 27/05/2022 Yes No
Protocol file version 1 11/08/2017 05/10/2022 No No
Other publications Detection and management of fraudulent participant responses 04/08/2023 04/08/2023 Yes No
Results article 01/06/2022 17/09/2024 Yes No

Additional files

ISRCTN41584028_PROTOCOL_V1_11Aug17.pdf

Editorial Notes

17/09/2024: Publication reference added.
04/08/2023: Publication reference added.
05/10/2022: Uploaded protocol (not peer reviewed).
27/05/2022: Publication reference added.
04/03/2022: Link to funder report added.
09/12/2019: The total final enrolment number has been added.
04/10/2019: The recruitment end date was changed from 30/09/2019 to 18/10/2019.
12/06/2019: The recruitment end date was changed from 31/05/2019 to 30/09/2019.
08/05/2019: The following changes were made to the trial record:
1. The recruitment start date was changed from 24/02/2019 to 10/04/2019.
2. The recruitment end date was changed from 26/04/2019 to 31/05/2019.
11/02/2019: The following changes were made:
1. The recruitment start date was updated from 01/07/2018 to 24/02/2019.
2. The recruitment end date was updated from 30/10/2018 to 26/04/2019.