CClinicalTrials.gg
Status unknownNCT04766619Updated Feb 23, 2021

Process Evaluation of OptimiseRx and PINCER

An observational study in Medication Errors, sponsored by University of Nottingham. Status unknown at 3 sites in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-23.

Sponsored by University of Nottingham · Observational

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
390
Ages
18 Years and older
Sex
All
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Study summary

This study aims to evaluate two interventions designed to make medication prescribing safer, OptimiseRx and PINCER, which are being used in general practices across England. The findings from the evaluation will be used to generate recommendations as to how these interventions can be used sustainably in the long-term.

Read the detailed description

This study has been designed to evaluate and gain an understanding of the 'real world' implementation, fidelity and medium and longer-term embedding and sustainability of two prescribing safety interventions: the computerised decision support (CDS) tool - Optimize Rx, and PINCER (pharmacist-led information technology intervention for reducing clinically important errors in medication management). The longitudinal process evaluation will involve observations, interviews, focus groups and questionnaires. The consolidated learning exercise, which aims to inform long-term, sustainable intervention use will involve a documentary analysis, interviews, focus groups, development workshops and a synthesis of the evaluation results.

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Conditions studied

  • Medication Errors

Keywords

  • Medication errors
  • Primary Care
  • Prescribing
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In context

Lead sponsor

University of Nottingham is the lead sponsor of 455 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Staff and stakeholders will be identified using existing networks and contact details of practice managers, lead GPs, CCG leads, AHSN staff and key stakeholders that are held by the research team. Patients will either be identified by practice staff or through a short, targeted advertisement placed on social media. Public and patient representatives will be identified through healthcare-related patient/public interests groups (e.g. charities, practice group, PPI networks).

Inclusion criteria

Staff and stakeholders

  • Able to give written informed consent
  • 18 years of age or over (no maximum age limit)
  • Staff members working in/for a practice or a CCG or the software developer which has received the intervention/s and have direct contact with it/them
  • Staff from relevant AHSNs, NHS England, the University of Nottingham or PRIMIS and other relevant staff who have had involvement in the PINCER rollout
  • Staff who have either had direct contact with, have an understanding of and/or are in a position to influence wider adoption of the PINCER and OptimseRx interventions (e.g. contracting, IT systems engineer, commissioner, etc.)

Patients

  • Able to give written informed consent
  • 18 years of age or over (no maximum age limit)
  • Patients registered with a general practice who have attended a consultation (or other related activity) for the PINCER intervention, or selected by their clinical care team, or attached to a patient group within a CCG or practice or those identified via social media who are living with a long-term health condition and/or who require regular blood tests to monitor their medication and have had a medication review within the past six months

Members of the public and patient representatives

  • Able to give written informed consent
  • 18 years of age or over (no maximum age limit)
  • Those who have either had direct contact with the PINCER intervention or have an understanding of the related medicines management issues in primary care

Exclusion criteria

Exclusion Criteria:

Staff and stakeholders

  • Unable to give written informed consent
  • Under 18 years of age

Patients

  • Unable to give written informed consent
  • Under 18 years of age
  • Those considered by their healthcare professional to be inappropriate to recruit due to psycho-social reasons or significant health reasons, e.g. terminal illness/diagnosis.

Members of the public and patient representatives

  • Unable to give written informed consent
  • Under 18 years of age
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Study design

Observational model
Other
Time perspective
Other
Enrollment
390 participants (estimated)
Patient registry
No

Groups and cohorts

  • Staff and stakeholders

    For the longitudinal process evaluation - staff and stakeholders who have had direct contact or involvement with and have an understanding of OptmiseRx and/or PINCER will be invited to take part in an interview or focus group, an observation and/or complete a questionnaire. For the consolidated learning exercise - those who are in a position to influence the wider adoption of these interventions will be invited to take part in an interview or development workshop.

  • Patients

    Patients registered with a practice who have attended a consultation (or other related activity) for the PINCER intervention OR selected by their clinical care team OR attached to a patient group within a Clinical Commissioning Group (CCG) or practice OR patients identified through social media who have a long-term health condition and/or are taking any medication that requires them to have regular blood tests and have had a medication review in the past six month will be invited to take part in an interview or focus group.

  • Public and patient representatives

    For the consolidated learning exercise - patient and public representatives who have an understanding of the related medicines management issues in primary care will be invited to take part in an interview or workshop.

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What researchers measure

Primary outcomes

  1. Primary Objective 1. Impact of influential factors in translation, implementation and sustained use of the OptimiseRx and PINCER interventions in the short-term, medium-term or long-term.

    Semi-structured interviews, focus groups and a questionnaire survey will be conducted to evaluate the contextual factors that influence the nature and extent of translation, implementation and sustained use of the PINCER intervention and prescribing safety indicator (PSI) functions, in particular, across different Academic Health Science Networks (AHSNs) and CCGs over prolonged time periods.

    Time frame: Time periods are classified as short-term (< 6 months), medium-term (6-18 months) or long-term (≥ 18 months) implementation

  2. Primary Objective 2. Fidelity of the PINCER intervention delivery and variations in success over time.

    Semi-structured interviews, focus groups and a questionnaire survey will be conducted to evaluate how the PINCER intervention has been delivered, experienced and has evolved over time in diverse contexts to achieve different degrees of success with particular reference to PSIs.

    Time frame: Time periods are classified as short-term (< 6 months), medium-term (6-18 months) or long-term (≥ 18 months) implementation

Secondary outcomes

  1. Secondary Objective 1. Impact and sustained delivery of the PINCER intervention and potential complementary use of OptimseRx and PINCER.

    A documentary analysis, workshops and data synthesis will be conducted to synthesise findings from the primary objectives and from the wider PRoTeCT study along with relevant policies and the perspectives of key stakeholders to generate recommendations for optimal nationwide implementation/impact and sustainable delivery of the OptimiseRx and PINCER interventions which are tailored to different audiences.

    Time frame: Short-term (< 6 months), medium-term (6-18 months) or long-term (≥ 18 months) implementation

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Study locations

2 of 3 sites recruiting
  • University of Edinburgh
    Edinburgh, United Kingdom
    Recruiting
  • University of Manchester
    Manchester, M13 9PT, United Kingdom
    Completed
  • University of Nottingham
    Nottingham, NG7 2RD, United Kingdom
    Recruiting
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References and documents

Publications

  • Avery AJ, Rodgers S, Cantrill JA, Armstrong S, Cresswell K, Eden M, Elliott RA, Howard R, Kendrick D, Morris CJ, Prescott RJ, Swanwick G, Franklin M, Putman K, Boyd M, Sheikh A. A pharmacist-led information technology intervention for medication errors (PINCER): a multicentre, cluster randomised, controlled trial and cost-effectiveness analysis. Lancet. 2012 Apr 7;379(9823):1310-9. doi: 10.1016/S0140-6736(11)61817-5. Epub 2012 Feb 21. Erratum In: Lancet. 2012 Jun 16;379(9833):2242. PubMed 22357106 ↗

Individual participant data

Plan to share: No — Individual patient data will only be shared amongst members of the research team.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04766619
Lead sponsor
University of Nottingham
Collaborators
National Institute for Health Research, United Kingdom
Responsible party
Sponsor
First posted
Feb 23, 2021
Start date
Feb 16, 2018
Primary completion
Aug 31, 2021 (estimated)
Completion
Feb 28, 2023 (estimated)
Last update
Feb 23, 2021

Study contacts

Libby Laing, PhD
Contact
libby.laing@nottingham.ac.uk
+44 (0) 7966774049
Anthony J Avery, MB, ChB
principal investigator · University of Nottingham

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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