ASPIRE 2: Action to Support Practices Implementing Research Evidence

ISRCTN	ISRCTN91989345
DOI	https://doi.org/10.1186/ISRCTN91989345
Secondary identifying numbers	18323

Submission date: 04/02/2015
Registration date: 20/02/2015
Last edited: 08/03/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Plain English summary under review

Study website

Contact information

Ms Suzanne Hartley
Scientific

17 Springfield Mount
Leeds
LS2 9NG
United Kingdom

Study information

Study design	Randomised; Interventional and Observational; Design type: Process of Care, Case-controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a patient information sheet
Scientific title	A cluster-randomised evaluation of adaptable implementation packages targeting high impact clinical practice recommendations in general practice
Study objectives	ASPIRE (Action to Support Practices Implementing Research Evidence) is a NIHR Programme Grant for Applied Research which aims to develop and evaluate an adaptable intervention package to target implementation of ‘high impact’ clinical recommendations in general practice. The programme focuses on ‘high impact’ clinical practice recommendations from NICE clinical guidelines and NHS Quality Standards where a measurable change in clinical practice can lead to significant patient benefit.
Ethics approval(s)	14/SC/1393; First MREC approval date 01/12/2014
Health condition(s) or problem(s) studied	Topic: Diabetes, Primary Care; Subtopic: Both, Primary care; Disease: Cardiovascular disease, All Diseases
Intervention	1. Audit and Feedback: This will be by practice and will be repeated regularly during the trial. It will include comparisons with other (anonymised) practices, information to illustrate benefits of changing practice, achievements if possible and educational messages. 2. Computerised Prompts and Decis: These will be built into the existing system or adapted from current SystmOne protocols and the content depends on the recommendation 3. Educational Outreach: Educational sessions using behaviour change techniques 4. GP Appraisal and Revalidation: Practices will be offered a tool kit of materials that will support GPs when preparing for appraisal and/or revalidation 5. Patient Mediated Intervention: Practices will also be provided with materials to assist in their communication with patients concerning the targeted recommendations
Intervention type	Other
Primary outcome measure	Adherence; Timepoint(s): Adherence will be measures up to 12 mth post randomisaion
Secondary outcome measures	N/A
Overall study start date	27/02/2015
Completion date	06/03/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	Planned Sample Size: 144; UK Sample Size: 144
Total final enrolment	144
Key inclusion criteria	General practices within the ten Clinical Commissioning Groups (CCGs) in West Yorkshire (Airedale Wharfedale and Craven CCG, Bradford City CCG, Bradford Districts CCG, Calderdale CCG, Greater Huddersfield CCG, Leeds North CCG, Leeds South and East CCG, Leeds West CCG, North Kirklees CCG, Wakefield CCG) will be eligible to participate in the trial provided they use the IT System, SystmOne clinical software for patient health records.
Key exclusion criteria	1. We will exclude the four general practices which participated in earlier pilot intervention work as they will already have been exposed to active intervention components. We will also exclude general practices where we have already interviewed GPs, nurses and practice managers as part of the intervention development process and which participate in the planned qualitative process evaluation (which will be the subject of a further protocol and ethics application). 2. Any general practices that do not use SystmOne software for patient health records will also be excluded.
Date of first enrolment	27/02/2015
Date of final enrolment	06/03/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Clinical Trials Research Unit

17 Springfield Mount
Leeds
LS2 9NG
United Kingdom

Sponsor information

University of Leeds
Hospital/treatment centre

Woodhouse Lane
Leeds
LS2 9JT
England
United Kingdom

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

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	29/02/2016		Yes	No
Results article	results	28/02/2020	02/03/2020	Yes	No
Protocol (other)			08/03/2023	No	No
Results article		01/04/2020	08/03/2023	Yes	No
Statistical Analysis Plan			08/03/2023	No	No

Editorial Notes

08/03/2023: The following changes were made to the trial record:
1. Publication reference added.
2. A link to the protocol file was added.
3. A link to the statistical analysis plan was added.
02/03/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
08/06/2017: Publication reference added.