Process Evaluation of OptimiseRx and PINCER

Medication Errors Clinical Trial

Official title:

Generating Recommendations for National Roll-out and Sustainable Use of Prescribing Safety Indicator Based Interventions Using Longitudinal Process Evaluation and a Consolidated Learning Exercise

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04766619
• Other study ID #: 17099
• Status: Recruiting
• Start date: February 16, 2018
• Est. completion date: February 28, 2023

Study information

• Verified date: February 2021
• Source: University of Nottingham
• Contact: Libby Laing, PhD
• Phone: +44 (0) 7966774049
• Email: libby.laing[@]nottingham.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 390
• Est. completion date: February 28, 2023
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Medication Errors

Locations

Country	Name	City	State
United Kingdom	University of Edinburgh	Edinburgh
United Kingdom	University of Manchester	Manchester
United Kingdom	University of Nottingham	Nottingham

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

References & 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. Erratum in: Lancet. 2012 Jun 16;379(9833):2242. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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.	Short-term (< 6 months), medium-term (6-18 months) or long-term (= 18 months) implementation

External Links

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