Development of the Medicines Optimisation Assessment Tool

Completed

• Conditions: Medicines Optimisation

• Registration Number: NCT02582463
• Lead Sponsor: University College, London

Brief 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). 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 Timeline

• Study First Submitted: 2015-10-12
• Study First Submitted QC: 2015-10-19
• Study First Posted: 2015-10-21
• Study Start: 2016-04
• Primary Completion: 2017-08
• Status Verified: 2017-10
• Study Completion: 2018-03-02
• Last Update Submitted: 2018-03-27
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1552

Inclusion Criteria

• subject admitted to the Medical Division (General, Emergency, and Elderly Medicine) at the study sites

Exclusion Criteria

• subject admitted for investigation-only
• subject not prescribed medication
• subject both admitted and subsequently discharged outside of core pharmacy working hours

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of MRPs experienced by study participants	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.

Secondary Outcome Measures

Name	Time	Method
Feasibility of using the MOAT (content validity and ease of use)	18 months	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.
Potential efficiency savings	18 months	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.
Potential clinical risk to patients through use of the MOAT	18 months	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).

Trial Locations

Locations (1)

Luton and Dunstable University Hospital; 🇬🇧 Luton, Bedfordshire, United Kingdom