Clinical trial NCT04766619: Process Evaluation of OptimiseRx and PINCER
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Medication Errors
Keywords: Medication errors
Primary Care
Prescribing
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2021-02-23
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Time periods are classified as short-term (< 6 months), medium-term (6-18 months) or long-term (≥ 18 months) implementation
measure: Primary Objective 2. Fidelity of the PINCER intervention delivery and variations in success over time.
timeFrame: Time periods are classified as short-term (< 6 months), medium-term (6-18 months) or long-term (≥ 18 months) implementation
Secondary outcomes:
measure: Secondary Objective 1. Impact and sustained delivery of the PINCER intervention and potential complementary use of OptimseRx and PINCER.
timeFrame: Short-term (< 6 months), medium-term (6-18 months) or long-term (≥ 18 months) implementation
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: University of Edinburgh
city: Manchester
country: United Kingdom
facility: University of Manchester
city: Nottingham
country: United Kingdom
facility: University of Nottingham
Study officials:
affiliation: University of Nottingham
name: Anthony J Avery, MB, ChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.