Does a teaching session given to pharmacists with influence over the prescribing of a regional group of general practices affect the number of low-priority medicines prescribed?

ISRCTN ISRCTN31218900
DOI https://doi.org/10.1186/ISRCTN31218900
Secondary identifying numbers OP-RECAP
Submission date
26/09/2018
Registration date
01/10/2018
Last edited
26/02/2025
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

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

Contact information

Dr Ben Goldacre
Scientific

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

Study information

Study designInterventional single-centre randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeOther
Participant information sheet No participant information sheet available
Scientific titleA Randomised controlled trial of structured Educational sessions to Clinical Commissioning Groups and Assessing the impact on primary care Prescribing
Study acronymRECAP
Study hypothesisNull hypothesis:
A structured education session on current prescribing performance to a CCG has no impact prescribing behaviour.
Ethics approval(s)Not required.
ConditionConditions treated by medications considered low-priority
InterventionClinical 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 typeOther
Primary outcome measureThe 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 measuresPrescribing 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 study start date16/07/2018
Overall study end date30/11/2019

Eligibility

Participant type(s)Other
Age groupNot Specified
SexNot Specified
Target number of participants40
Total final enrolment40
Participant inclusion criteriaClinical Commissioning Groups (CCGs) in England with the highest expenditure on low-priority items per 1000 registered patients.
Participant exclusion criteriaCCGs where members of the DataLab team are employed or have been recently employed.
Recruitment start date03/10/2018
Recruitment end date30/11/2018

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

NHS England
80 London Road
London
SE1 6LH
United Kingdom

Sponsor information

NHS England
Other

80 London Road
London
SE1 6LH
United Kingdom

ROR logo "ROR" https://ror.org/02wnqcb97

Funders

Funder type

Not defined

NHS England

No information available

Health Foundation

No information available

Results and Publications

Intention to publish date31/05/2021
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryStored in repository
Publication and dissemination planWe 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 planThe 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Basic results 24/11/2020 24/11/2020 No No
Results article 25/02/2025 26/02/2025 Yes No

Additional files

ISRCTN31218900_BasicResults_24Nov20.pdf
Uploaded 24/11/2020

Editorial Notes

26/02/2025: Publication reference added.
24/11/2020: The following changes were made to the trial record:
1. The basic results of this trial have been uploaded as an additional file.
2. Total final enrolment number added.
3. The intention to publish date was changed from 06/05/2020 to 31/05/2021.
03/10/2018: The recruitment start date has been changed from 26/09/2018 to 03/10/2018