Medicines Optimisation Clinical Trial
— MOATOfficial title:
Development of the Medicines Optimisation Assessment Tool (MOAT) - Targeting Hospital Pharmacists' Input to Reduce Risks and Improve Patient Outcomes
| Verified date | October 2017 |
| Source | University College, London |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1552 |
| Est. completion date | March 2, 2018 |
| Est. primary completion date | August 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Luton and Dunstable University Hospital | Luton | Bedfordshire |
| Lead Sponsor | Collaborator |
|---|---|
| University College, London | National Institute for Health Research, United Kingdom |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Through study completion (discharge from hospital), an average of 6 days | |
| Secondary | 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. | 18 months | |
| Secondary | 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. | 18 months | |
| Secondary | 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). | 18 months |