Plain English Summary
Plain English summary under review
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
18323
Study information
Scientific title
A cluster-randomised evaluation of adaptable implementation packages targeting high impact clinical practice recommendations in general practice
Acronym
Study hypothesis
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
14/SC/1393; First MREC approval date 01/12/2014
Study design
Randomised; Interventional and Observational; Design type: Process of Care, Case-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measure
Adherence; Timepoint(s): Adherence will be measures up to 12 mth post randomisaion
Secondary outcome measures
N/A
Overall trial start date
27/02/2015
Overall trial end date
06/03/2015
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Planned Sample Size: 144; UK Sample Size: 144
Total final enrolment
144
Participant 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.
Recruitment start date
27/02/2015
Recruitment end date
06/03/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Clinical Trials Research Unit
17 Springfield Mount
Leeds
LS2 9NG
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
unknown
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2016 protocol in https://www.ncbi.nlm.nih.gov/pubmed/26923369
2020 results in https://www.ncbi.nlm.nih.gov/pubmed/32109257 (added 02/03/2020)