Patient Safety Clinical Trial
Official title:
A Randomised Pilot Study of a Pharmacist-led Retrospective Review of Prescribing by General Practitioners in Training (REVISiT) Intervention
NCT number | NCT04586595 |
Other study ID # | 19007 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 30, 2020 |
Est. completion date | December 16, 2022 |
Verified date | December 2022 |
Source | University of Nottingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 9 |
Est. completion date | December 16, 2022 |
Est. primary completion date | August 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | NHS Derbyshire | Derby | Derbyshire |
United Kingdom | NHS Dorset CCG | Dorchester | |
United Kingdom | NHS Lincolnshire | Lincoln | Lincolnshire |
United Kingdom | NHS Nottingham | Nottingham | Nottinghamshire |
Lead Sponsor | Collaborator |
---|---|
University of Nottingham | University of Manchester |
United Kingdom,
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.
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. — View Citation
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. — View Citation
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.
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.
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.
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change in the prevalence and types of suboptimal prescribing | Suboptimal prescribing 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 suboptimal prescribing observed | 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 | Participant recruitment and attrition | Will include the number of participants recruited and completing the study as per study group allocation (where possible, reasons for declining participation or withdrawal from the study will be recorded) | Study completion | |
Secondary | Interrater reliability between review pharmacists | Each review pharmacist will have 10% of their prescribing review, coded by a second pharmacist to provide an assessment of interrater reliability with regards to the prescribing errors and suboptimal prescribing identified | 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 | Sample size estimation for the definitive randomised controlled trial | Data generated from the randomised pilot study will be used to estimate a sample size for the definitive randomised controlled trial | Study completion - estimated to be one year after the commencement of the study | |
Secondary | Experiences of participants in relation to the randomised controlled trial | Participants will be involved in a semi-structured interview to explore their experiences of participating in the randomised controlled trial including allocation and adherence to study treatment groups; and to explore what modifications, if any, may enhance the acceptability and success of conducting a future definitive randomised controlled trial of the REVISiT intervention in general practice | This will take place at a time no longer than 24 weeks post baseline | |
Secondary | Experiences of participants in relation to the REVISiT intervention | Participants will be involved in a semi-structured interview to explore their experiences of the REVISiT intervention including (where relevant) the - pharmacist training, database, REVISiT case-law for guiding the review process, mechanisms of action (e.g. whether feedback increases capability and motivation) and the impact of the prescribing review on current and future prescribing practice. | This will take place at a time no longer than 24 weeks post baseline |
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