A Randomised Pilot Study of the REVISiT Intervention

NCT04586595 | Completed

• 1 other identifier: 19007
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 4

Brief Summary

In 2012, the General Medical Council (GMC) funded PRACtICe (PRevalence And Causes of prescrIbing errors in general practiCe) study, reported that 1 in 20 prescriptions in general practice were found to have a prescribing or monitoring error. The PRACtICe study also proposed some strategies to consider to improve prescribing safety. Further to the PRACtICe study, in line with recommendation from the Medical Research Council (MRC) for developing complex interventions, we conducted a series of focus groups with health care professionals and members of the public to identify possible ways to improve the prescribing education provided for general practitioner (GP) trainees - a group that was identified as likely to benefit from additional education and training in prescribing safety. These focus group discussions identified a pharmacist-led review of the prescribing done by GP trainees, together with feedback, as a promising potential intervention. This intervention, named REVISiT, was piloted with ten trainees and their trainers in the East Midlands. The error rate for the trainees was recorded as 9%. Interviews with the trainees and trainers undertaken following the intervention highlighted that REVISiT was positively received. Some GPs gave examples of how their prescribing practice had changed following the intervention. After this pilot study, we conducted another study involving interviews, focus groups and a stakeholder event with key stakeholders (practice, policy, legal and members of the public) to explore the next steps for REVISiT. Whilst some participants proposed that REVISiT be immediately implemented with minor modifications, others pointed to the need to establish the impact of the intervention more broadly (including its impact in areas other than education and training). Additionally, they highlighted the importance of establishing its effectiveness in order to support making a substantial case for future allocation of resources. Conducting a randomised controlled trial (RCT) would help establish the effectiveness of the REVISIT intervention and its impact on areas of professional practice that may impact prescribing safety. However, before we can do this, there are components of the REVISiT intervention and RCT process that we need to further explore, test and refine in order for it to be employed on a wider basis. This pilot study of the REVISiT intervention is being undertaken to do this further exploration, testing and refining.

Conditions

Patient Safety; Inappropriate Prescribing; Medication Errors

Keywords

General practice; Pharmacist role; GP training; Educational interventions

Outcome Measures

Primary Outcomes (1)

• Change in the prevalence and types of prescribing errors

  Prescribing errors will be identified following a pharmacist-led retrospective review of prescribing done by GP trainees to assess the impact of the REVISIT intervention on the types and numbers of prescribing errors

  The first review of prescribing corresponds to a time of no more than 4 weeks post baseline. The comparative review of prescribing corresponds to a time of no more than 20 weeks post baseline

Secondary Outcomes (6)

• Change in the prevalence and types of suboptimal prescribing

  The first review of prescribing corresponds to a time of no more than 4 weeks post baseline. The comparative review of prescribing corresponds to a time of no more than 20 weeks post baseline

• Participant recruitment and attrition

  Study completion

• Interrater reliability between review pharmacists

  The first review of prescribing corresponds to a time of no more than 4 weeks post baseline. The comparative review of prescribing corresponds to a time of no more than 20 weeks post baseline

• Sample size estimation for the definitive randomised controlled trial

  Study completion - estimated to be one year after the commencement of the study

• Experiences of participants in relation to the randomised controlled trial

  This will take place at a time no longer than 24 weeks post baseline

Study Arms (2)

Intervention arm

EXPERIMENTAL

GP trainees in this arm will receive the REVISiT intervention which will involve having their prescribing reviewed and feedback provided, at two time points (approximately 100 prescriptions at each time point) separated by approximately a 3-month time period.

Other: REVISiT intervention

Control arm

NO INTERVENTION

GP trainees in this arm will continue with training as usual and will have their prescribing (approximately 200 prescriptions) reviewed once but representing two time points - separated by an approximate 3-month time period. Feedback will occur at one time point, to cover the review for the 200 prescriptions.

Interventions

REVISiT intervention OTHER

REVISiT is a pharmacist-led retrospective review of prescribing followed by a feedback meeting to discuss the review findings.

Intervention arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who are able and willing to give written informed consent and are either:
• GPs in their final year of training who have received approval/permission from their GP trainer to participate in the study or;
• GP trainers with a trainee who has consented to take part in the pilot study or;
• Primary care pharmacists (employed by the practice, the primary care network (PCN) or the clinical commissioning group (CCG) in which the GP in training works) with ideally, at least 6-months experience of working in GP practices or;
• Pharmacists specially trained to deliver the REVISiT intervention and trained on good clinical practice (GCP) in research

You may not qualify if:

• Participants not able or willing to give written informed consent
• GP trainees with significant participation in other studies that could impact / could be impacted by their taking part in this randomised pilot study
• GP trainees who do not have the support of their trainer to participate in the study
• GP trainers who do not wish for their trainee to be involved with the study
• Pharmacists who do not have the required experience (ideally at least 6-month) of working in general practice in England
• Pharmacists who are not trained in delivering the REVISiT intervention or on GCP as part of this study

Sponsors & Collaborators

• University of Nottingham: lead
• University of Manchester: collaborator

Study Sites (4)

NHS Derbyshire

Derby, Derbyshire, United Kingdom

Location

NHS Lincolnshire

Lincoln, Lincolnshire, United Kingdom

Location

NHS Nottingham

Nottingham, Nottinghamshire, United Kingdom

Location

NHS Dorset CCG

Dorchester, United Kingdom

Location

Related Publications (7)

• Duerden M, Millson D, Avery A and Smart S. The quality of GP prescribing: An Inquiry into the Quality of General Practice in England. 2011.

  BACKGROUND

• Avery T, Barber N, Ghaleb M, Franklin BD, Armstrong S, Crowe S, Dhillon S, Freyer A, Howard R, Pezzolesi C, Serumaga B, Swanwick G and Talabi O. Investigating the prevalence and causes of prescribing errors in general practice: The PRACtICe Study (PRevalence And Causes of prescrIbing errors in general practiCe). London: A report for the GMC; 2012.

  BACKGROUND

• Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.

  PMID: 18824488 BACKGROUND

• Marsden K, Avery T, Knox R, Gookey G, Salema N and Bassi M. Focus group study to explore ideas on potential interventions for reducing prescribing errors in general practice. Pharmacoepidemiology and Drug Safety. 2013; 22:681

  BACKGROUND

• Knox R, Gookey G, Salema N, Marsden K, Swanwick G, Bassi M, Silcock N, Bell B, Mehta R, Rodgers S, Coulton A and Avery T, 2017. Retrospective review of prescriptions issued by GPs in training - a pilot study. Pharmacoepidemiology and Drug Safety. 2017; 26: 3-20.

  BACKGROUND

• Knox R, Salema N, Gookey G, Marsden K, Bell B, Mehta R, Roders R, McCartney K and Avery T. REVISIT, the next stage: developing plans for wider application of a retrospective review of prescribing of GPs in training. British Journal of General Practice. 2018; 68 (suppl 1): bjgp18X697337.

  BACKGROUND

• Carver CS, Scheier MF. Control theory: a useful conceptual framework for personality-social, clinical, and health psychology. Psychol Bull. 1982 Jul;92(1):111-35. No abstract available.

  PMID: 7134324 BACKGROUND

Study Officials

• Richard A Knox, MBChB

  University of Nottingham

  PRINCIPAL INVESTIGATOR

• Nde-Eshimuni M Salema, PhD

  University of Nottingham

  STUDY DIRECTOR

• Anthony J Avery, DM

  University of Nottingham

  STUDY DIRECTOR

• Darren Ashcroft, PhD

  University of Manchester

  STUDY DIRECTOR

• Chris Armitage, PhD

  University of Manchester

  STUDY DIRECTOR

• Brian Bell, PhD

  University of Nottingham

  STUDY DIRECTOR

• Glen Swanwick

  Patient and Public Involvement

  STUDY DIRECTOR

• Jeanne-Anna Charly

  Patient and Public Involvement

  STUDY DIRECTOR

• Gill Gookey

  Clinical Commissioning Group collaborators

  STUDY DIRECTOR

• Mindy Bassi

  Clinical Commissioning Group collaborators

  STUDY DIRECTOR

• Richard Williams, BA

  University of Manchester

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Researchers responsible for analysis of error rate and rate of suboptimal prescribing will not know which arm the results have come from
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel two-arm randomised pilot study

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: October 14, 2020
• Study Start: July 30, 2020
• Primary Completion: August 1, 2022
• Study Completion: December 16, 2022
• Last Updated: December 22, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)