Process Evaluation of OptimiseRx and PINCER

• Conditions: Medication Errors

• Registration Number: NCT04766619
• Lead Sponsor: University of Nottingham

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.

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.

Study Timeline

• Study Start: 2018-02-16
• Study First Submitted: 2021-01-25
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-19
• Last Update Submitted: 2021-02-19
• Study First Posted: 2021-02-23
• Last Update Posted: 2021-02-23
• Primary Completion: 2021-08-31
• Study Completion: 2023-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 390

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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	Time periods are classified as short-term (< 6 months), medium-term (6-18 months) or long-term (≥ 18 months) implementation	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.
Primary Objective 2. Fidelity of the PINCER intervention delivery and variations in success over time.	Time periods are classified as short-term (< 6 months), medium-term (6-18 months) or long-term (≥ 18 months) implementation	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.

Secondary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (3)

University of Manchester; 🇬🇧 Manchester, United Kingdom

University of Edinburgh; 🇬🇧 Edinburgh, United Kingdom

University of Nottingham; 🇬🇧 Nottingham, United Kingdom