Process Evaluation of OptimiseRx and PINCER

NCT ID: NCT04766619

Last Updated: 2021-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

390 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-16

Study Completion Date

2023-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Medication Errors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

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.

No interventions assigned to this 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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anthony J Avery, MB, ChB

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Edinburgh

Edinburgh, , United Kingdom

Site Status RECRUITING

University of Manchester

Manchester, , United Kingdom

Site Status COMPLETED

University of Nottingham

Nottingham, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Libby Laing, PhD

Role: CONTACT

+44 (0) 7966774049

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Azwa Shamsuddin, PhD

Role: primary

+44 (0)7788 396 708

Libby Laing, PhD

Role: primary

+44 (0) 7966774049

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 22357106 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://www.nottingham.ac.uk/research/groups/medicinesafetyeffectivehealthcare/protect-study/wp4.aspx

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

17099

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Anticoagulation Adherence Measurement Strategies
NCT07129395 ACTIVE_NOT_RECRUITING
Polypharmacy Outpatient Clinic
NCT03911934 COMPLETED NA
Medication Use and Quality of Life Among Older People
NCT05123313 ACTIVE_NOT_RECRUITING NA
YouScript IMPACT Registry
NCT02191358 COMPLETED