Medication ErrorsNCT04766619
Process Evaluation of OptimiseRx and PINCER
An observational study of Medication Errors, run by University of Nottingham at 3 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medication Errors
- How many people
- 390 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 16 Feb 2018to 28 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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.)
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- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 2 recruiting
- Recruiting
University of Edinburgh
Edinburgh
Azwa Shamsuddin, PhD, +44 (0)7788 396 708, azwa.shamsuddin@ed.ac.uk
- Completed
University of Manchester
Manchester, M13 9PT
- Recruiting
University of Nottingham
Nottingham, NG7 2RD
Libby Laing, PhD, +44 (0) 7966774049, libby.laing@nottingham.ac.uk
About this study
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
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.
Read the 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.
- Conditions
- Medication Errors
- Keywords
- Medication errors, Primary Care, Prescribing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
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.
Measured: Short-term (< 6 months), medium-term (6-18 months) or long-term (≥ 18 months) implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start16 Feb 2018
- Primary completion31 Aug 2021 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication ErrorsStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Anthony J Avery, MB, ChB, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766619
- Sponsor's protocol ID
- 17099
- Status last verified
- Feb 2021
- First submitted
- 25 Jan 2021
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data will only be shared amongst members of the research team.
Publications
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.
PubMed 22357106
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04766619
- Acronym / sponsor ID
- 17099
- Conditions
- Medication Errors
- Keywords
- Medication errors, Primary Care, Prescribing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 16 Feb 2018 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (10 listed)
- Staff and stakeholders
- Unable to give written informed consent
- Under 18 years of age
- Patients
- Unable to give written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 frame: 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 frame: 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.
1 secondary outcome
Secondary Objective 1. Impact and sustained delivery of the PINCER intervention and potential complementary use of OptimseRx and PINCER.
Time frame: Short-term (< 6 months), medium-term (6-18 months) or long-term (≥ 18 months) implementation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Background: PubMed 22357106Avery 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.
- Medicine Safety and Effective Healthcare Research - PRoTeCT Study Work Package 4Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual patient data will only be shared amongst members of the research team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony J Avery, MB, ChB principal investigator
University of Nottingham
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication Errors, run by University of Nottingham at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Libby Laing, PhD (+44 (0) 7966774049, libby.laing@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Time periods are classified as short-term (< 6 months), medium-term (6-18 months) or long-term (≥ 18 months) implementation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04766619, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.