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 |
| Protocol serial number | OP-RECAP |
| Sponsor | NHS England |
| Funders | NHS England, Health Foundation |
- 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
Plain English summary of protocol
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
Scientific
Centre for Evidence Based Medicine
Nuffield Department of Primary Care Health Sciences
University of Oxford
Oxford
OX2 6GG
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional single-centre randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A Randomised controlled trial of structured Educational sessions to Clinical Commissioning Groups and Assessing the impact on primary care Prescribing |
| Study acronym | RECAP |
| Study objectives | Null hypothesis: A structured education session on current prescribing performance to a CCG has no impact prescribing behaviour. |
| Ethics approval(s) | Not required. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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: |
| Key secondary outcome measure(s) |
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: |
| Completion date | 30/11/2019 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 40 |
| Total final enrolment | 40 |
| Key inclusion criteria | Clinical Commissioning Groups (CCGs) in England with the highest expenditure on low-priority items per 1000 registered patients. |
| Key exclusion criteria | CCGs where members of the DataLab team are employed or have been recently employed. |
| Date of first enrolment | 03/10/2018 |
| Date of final enrolment | 30/11/2018 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
London
SE1 6LH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in repository |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 25/02/2025 | 26/02/2025 | Yes | No | |
| Basic results | 24/11/2020 | 24/11/2020 | No | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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
