Condition category
Not Applicable
Date applied
26/09/2018
Date assigned
01/10/2018
Last edited
10/10/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In England approximately £9.2 billion is spent annually on 1.1. billion prescriptions. NHS England recently released guidance to CCGs (regional NHS organisations who are responsible for buying and planning all of the standard NHS services for people in their area, like medicines and hip operations) on 18 prescription items, in order to reduce costs, improve quality and safety, and encourage more consistency in prescribing across general practices. The items are mostly treatments lacking evidence of clinical effectiveness, e.g. homeopathic remedies, or where more cost-effective items are available, e.g. perindopril arginine. The aim of the study is to see if providing a teaching session to pharmacists working in CCGs has an effect on the amount of these 18 prescriptions given out by general practices in their area.

Who can participate?
Professionals working in or on behalf of CCGs

What does the study involve?
Half of the CCGs will receive a teaching session (one session per CCG) and the comparison group will receive nothing from NHS England beyond normal implementation materials and data.

What are the possible benefits and risks of participating?
The participants will benefit from a teaching session which is intended to increase their awareness and support them to implement the guidance on low priority treatments. This is a low risk intervention, but the time burden may divert from other tasks.

Where is the study run from?
Study run from the Centre for Evidence Based Medicine at the University of Oxford and teaching sessions will conducted in 20 CCGs at their offices (or other location of their choosing) across England.

When is the study starting and how long is it expected to run for?
July 2018 to November 2019

Who is funding the study?
This is low cost agile evaluation of a teaching session that NHS England were planning to do already. The costs of this are borne by NHS England in their routine budgets and the University of Oxford - DataLab (UK) is funding the staff time of the evaluating research.

Who is the main contact?
Ben Goldacre
ben.goldacre@phc.ox.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ben Goldacre

ORCID ID

Contact details

Centre for Evidence Based Medicine
Nuffield Department of Primary Care Health Sciences
University of Oxford
Oxford
OX2 6GG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

OP-RECAP

Study information

Scientific title

A Randomised controlled trial of structured Educational sessions to Clinical Commissioning Groups and Assessing the impact on primary care Prescribing

Acronym

RECAP

Study hypothesis

Null hypothesis:
A structured education session on current prescribing performance to a CCG has no impact prescribing behaviour.

Ethics approval

Not required.

Study design

Interventional single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

Conditions treated by medications considered low-priority

Intervention

Clinical Commissioning Groups (CCGs) will be randomised into the intervention or the control group. Randomisation will take place in software. Those randomised to the intervention group will be invited to participate in a single educational intervention.The intervention will be a single education session, delivered in-person by a senior NHS England representative at a location of each CCG’s choice. It will focus on implementation of NHS England low-priority prescribing guidance and will include an audit-and-feedback element. It will be 1-2 hours in duration. Interventions will take place over a 3 month period. CCGs in the control group will not be contacted.

Intervention type

Other

Phase

Drug names

Primary outcome measure

The following are assessed by the change from the baseline (April to September 2018) to the follow-up (April to September 2019) using a regression model:
1. Cost per 1,000 patients for all 18 pre-specified “low-priority” treatments combined
2. Total items per 1000 across all 18 low priority treatments.

Secondary outcome measures

Prescribing measures are assessed by the change from the baseline (April to September 2018) to the follow-up (April to September 2019) using a regression model:
3. Cost per 1,000 patients for top 3 pre-specified “low-priority” treatments combined.
4. Total items prescribed per 1000 registered patients for Co-proxamol.
5. Total items prescribed per 1000 registered patients for Dosulepin

Engagement measures:
1. Number of page views over one month on CCG page showing low-priority measures, assessed using web page views data from Google analytics, as the change from the baseline for 1 month before/after and change between April to September 2018 and April to September 2019
2. Number of page views over one month on practice pages showing low-priority measures, grouped up to CCGs, assessed using web page views data from Google analytics, as the change from the baseline for 1 month before/after and change between April to September 2018 and April to September 2019
3. Number of registrations to OpenPrescribing CCG email alerts alerts, assessed by counting new email sign-ups within 3 months of the intervention (compared between the intervention and control groups)
4. Number of registrations to OpenPrescribing Practice email alerts grouped up to CCG, assessed by counting new email sign-ups within 3 months of the intervention (compared between the intervention and control groups)

Other:
Change in number of CCGs with guidance included in workplans, assessed via an NHS England survey pre-session (2017-2018) and 6 months later (2018-2019) using basic descriptive statistics

Overall trial start date

16/07/2018

Overall trial end date

30/11/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Clinical Commissioning Groups (CCGs) in England with the highest expenditure on low-priority items per 1000 registered patients.

Participant type

Other

Age group

Not Specified

Gender

Not Specified

Target number of participants

40

Participant exclusion criteria

CCGs where members of the DataLab team are employed or have been recently employed.

Recruitment start date

03/10/2018

Recruitment end date

30/11/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NHS England
80 London Road
London
SE1 6LH
United Kingdom

Sponsor information

Organisation

NHS England

Sponsor details

80 London Road
London
SE1 6LH
United Kingdom

Sponsor type

Other

Website

Funders

Funder type

Not defined

Funder name

NHS England

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Health Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We will publish results in a peer-reviewed publication.

All of the analysis code will be publicly available. The trialists plan to publish the results in peer-reviewed journals within 12 months of results being available. They will post the results online before 12 months of trial completion if journal publication is not possible within this timeline.

IPD sharing statement
The datasets generated during and/or analysed during the current study will be shared online openly to all at Figshare following publication of results, if not sooner.

Intention to publish date

06/05/2020

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

03/10/2018: The recruitment start date has been changed from 26/09/2018 to 03/10/2018