Process Evaluation of OptimiseRx and PINCER

NCT04766619 | Unknown

• 1 other identifier: 17099
• Study Type: observational
• Target: 390
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Medication Errors

Keywords

Medication errors; Primary Care; Prescribing

Outcome Measures

Primary Outcomes (2)

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

• 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 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.

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

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Staff and stakeholders
• Able to give written informed consent
• 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
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (3)

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

Related Publications (1)

• 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.

  PMID: 22357106 BACKGROUND

Related Links

• Medicine Safety and Effective Healthcare Research - PRoTeCT Study Work Package 4

Study Officials

• Anthony J Avery, MB, ChB

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Libby Laing, PhD

CONTACT

+44 (0) 7966774049; libby.laing@nottingham.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 23, 2021
• Study Start: February 16, 2018
• Primary Completion: August 31, 2021
• Study Completion: February 28, 2023
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)