Medicines OptimisationMOATNCT02582463
Development of the Medicines Optimisation Assessment Tool
An observational study of Medicines Optimisation, run by University College, London at 1 site in United Kingdom.
Trial summary
The purpose of this study is to develop a prediction-tool, the Medicines Optimisation Assessment Tool (MOAT), to assist hospital pharmacists identify patients at highest risk of preventable medication related problems (MRPs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medicines Optimisation
- How many people
- 1,552 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2016to 2 Mar 2018
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the Medical Division (General, Emergency, and Elderly Medicine) at the Luton and Dunstable University Hospital and Watford General Hospital
Who may be able to join
- subject admitted to the Medical Division (General, Emergency, and Elderly Medicine) at the study sites
Who cannot join
- subject admitted for investigation-only
- subject not prescribed medication
- subject both admitted and subsequently discharged outside of core pharmacy working hours
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Luton and Dunstable University Hospital
Luton, Bedfordshire, LU40DZ
About this study
Official title: Development of the Medicines Optimisation Assessment Tool (MOAT) - Targeting Hospital Pharmacists' Input to Reduce Risks and Improve Patient Outcomes
The purpose of this study is to develop a prediction-tool, the Medicines Optimisation Assessment Tool (MOAT), to assist hospital pharmacists identify patients at highest risk of preventable medication related problems (MRPs). This has the potential to permit pharmacists to identify and focus on the small number of patients (approximately 6%) who are likely to experience a significant MRP while in hospital.
Read the detailed description
The purpose of this study is to develop a prediction-tool, the Medicines Optimisation Assessment Tool (MOAT), to assist hospital pharmacists identify patients at highest risk of preventable medication related problems (MRPs).
The MOAT will be developed following recommendations of the PROGnosis RESearch Strategy (PROGRESS) partnership. A prospective cohort study of 1,500 patients will be used to develop the MOAT from the medical wards of two UK hospitals. Data will be collected on prognostic factors (selected based on a review of published literature and expert opinion) for each patient, together with details of MRPs that occur. All MRPs will be reviewed by an expert panel who will grade for severity and preventability using recognised criteria. Multivariable logistic regression models will be used to determine the relationship between potential risk factors such as polypharmacy, renal impairment, and the use of 'high risk' medicines, and the study outcome of preventable medication related problems that are at least moderate in severity. Bootstrapping will be used to adjust the MOAT for optimism, and predictive performance will be assessed using calibration and discrimination. A simplified scoring system will also be developed, which will be assessed for sensitivity and specificity.
The intention of this research is to develop a prediction-tool (the MOAT), which has the potential to be adopted widely into clinical practice. If the initial research is successful in producing a prediction-tool with good predictive performance further research will be carried out to assess how feasible it would be to use the MOAT in practice, the potential efficiency savings, and an assessment of clinical risk to patients through use of the MOAT.
- Conditions
- Medicines Optimisation
- Keywords
- Risk Assessment, Hospitals, Pharmacists, Medication Systems, Patient Selection, Prognosis research
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of MRPs experienced by study participants
The outcome measure (i.e. all MRPs) will be graded for severity and preventability, then multivariate analysis such as logistic regression models will be used to determine the relationship between predictors (prognostic factors) and the outcome (MRPs which are at least moderate in severity and preventable). The objective will be to find the best combinations of predictors that are highly sensitive for detecting the outcome measure while achieving the maximum possible specificity.
Measured: Through study completion (discharge from hospital), an average of 6 days
Secondary outcomes (3)
Feasibility of using the MOAT (content validity and ease of use)
Content validity will be assessed to ensure that clinicians consider the items in the MOAT to be clinically sensible, no obvious items are missing, the method of grouping the individual predictors is reasonable, and the items seem appropriate for the purpose of the tool. Ease of use depends on the length of time needed to apply the tool and the simplicity of interpretation. A consensus development technique will be used to generate consensus on content validity and simplicity of interpretation. Time to apply the MOAT will be assessed by observation.
Measured: 18 months
Potential efficiency savings
The impact of the MOAT in terms of potential workload for pharmacists will be informed by the number of patients who screen positive (from internal validation). This will indicate the proportion of patients who would be expected to require review by a pharmacist, i.e. the total number that pharmacists would need to see to identify those at highest risk of MRPs.
Measured: 18 months
Potential clinical risk to patients through use of the MOAT
Patients who experience an MRP but would be excluded from pharmacist review by the MOAT (i.e. false negatives) will be reviewed in detail to identify the potential clinical risk (i.e. severity of missed events).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startApr 2016
- Primary completionAug 2017
- Study completion2 Mar 2018
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 Medicines OptimisationStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,552 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Cathy Geeson, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582463
- Sponsor's protocol ID
- 15/0525
- Other IDs
- CDRF-2014-05-033
- Acronym
- MOAT
- Status last verified
- Oct 2017
- First submitted
- 12 Oct 2015
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Geeson C, Wei L, Franklin BD. Medicines Optimisation Assessment Tool (MOAT): a prognostic model to target hospital pharmacists' input to improve patient outcomes. Protocol for an observational study. BMJ Open. 2017 Jun 14;7(6):e017509. doi: 10.1136/bmjopen-2017-017509.
PubMed 28615279
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of the Medicines Optimisation Assessment Tool (MOAT) - Targeting Hospital Pharmacists' Input to Reduce Risks and Improve Patient Outcomes
- ClinicalTrials.gov ID
- NCT02582463
- Acronym / sponsor ID
- MOAT / 15/0525
- Conditions
- Medicines Optimisation
- Keywords
- Risk Assessment, Hospitals, Pharmacists, Medication Systems, Patient Selection, Prognosis research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,552 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Apr 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- 2 Mar 2018 (actual)
- First posted
- 21 Oct 2015 (estimated)
- 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.
The purpose of this study is to develop a prediction-tool, the Medicines Optimisation Assessment Tool (MOAT), to assist hospital pharmacists identify patients at highest risk of preventable medication related problems (MRPs). This has the potential to permit pharmacists to identify and focus on the small number of patients (approximately 6%) who are likely to experience a significant MRP while in hospital.
Detailed description
The purpose of this study is to develop a prediction-tool, the Medicines Optimisation Assessment Tool (MOAT), to assist hospital pharmacists identify patients at highest risk of preventable medication related problems (MRPs).
The MOAT will be developed following recommendations of the PROGnosis RESearch Strategy (PROGRESS) partnership. A prospective cohort study of 1,500 patients will be used to develop the MOAT from the medical wards of two UK hospitals. Data will be collected on prognostic factors (selected based on a review of published literature and expert opinion) for each patient, together with details of MRPs that occur. All MRPs will be reviewed by an expert panel who will grade for severity and preventability using recognised criteria. Multivariable logistic regression models will be used to determine the relationship between potential risk factors such as polypharmacy, renal impairment, and the use of 'high risk' medicines, and the study outcome of preventable medication related problems that are at least moderate in severity. Bootstrapping will be used to adjust the MOAT for optimism, and predictive performance will be assessed using calibration and discrimination. A simplified scoring system will also be developed, which will be assessed for sensitivity and specificity.
The intention of this research is to develop a prediction-tool (the MOAT), which has the potential to be adopted widely into clinical practice. If the initial research is successful in producing a prediction-tool with good predictive performance further research will be carried out to assess how feasible it would be to use the MOAT in practice, the potential efficiency savings, and an assessment of clinical risk to patients through use of the MOAT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the Medical Division (General, Emergency, and Elderly Medicine) at the Luton and Dunstable University Hospital and Watford General Hospital
Key inclusion criteria (1 listed)
- subject admitted to the Medical Division (General, Emergency, and Elderly Medicine) at the study sites
Key exclusion criteria (3 listed)
- subject admitted for investigation-only
- subject not prescribed medication
- subject both admitted and subsequently discharged outside of core pharmacy working hours
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
Number of MRPs experienced by study participants
Time frame: Through study completion (discharge from hospital), an average of 6 days
The outcome measure (i.e. all MRPs) will be graded for severity and preventability, then multivariate analysis such as logistic regression models will be used to determine the relationship between predictors (prognostic factors) and the outcome (MRPs which are at least moderate in severity and preventable). The objective will be to find the best combinations of predictors that are highly sensitive for detecting the outcome measure while achieving the maximum possible specificity.
3 secondary outcomes
Feasibility of using the MOAT (content validity and ease of use)
Time frame: 18 months
Potential efficiency savings
Time frame: 18 months
Potential clinical risk to patients through use of the MOAT
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Derived from this study: PubMed 28615279Geeson C, Wei L, Franklin BD. Medicines Optimisation Assessment Tool (MOAT): a prognostic model to target hospital pharmacists' input to improve patient outcomes. Protocol for an observational study. BMJ Open. 2017 Jun 14;7(6):e017509. doi: 10.1136/bmjopen-2017-017509.
- Individual participant dataSharing planned: No
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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.
Cathy Geeson principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medicines Optimisation, run by University College, London at 1 site 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of MRPs experienced by study participants (time frame: Through study completion (discharge from hospital), an average of 6 days). 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 NCT02582463, 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 29 Mar 2018.