Condition category
Nutritional, Metabolic, Endocrine
Date applied
04/02/2015
Date assigned
20/02/2015
Last edited
20/02/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Plain English summary under review

Trial website

http://medhealth.leeds.ac.uk/info/650/aspire//

Contact information

Type

Scientific

Primary contact

Ms Suzanne Hartley

ORCID ID

Contact details

17 Springfield Mount
Leeds
LS2 9NG
United Kingdom

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 measures

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

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

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

Sponsor information

Organisation

University of Leeds

Sponsor details

Woodhouse Lane
Leeds
LS2 9JT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes