Development of the Medicines Optimisation Assessment Tool

NCT ID: NCT02582463

Last Updated: 2018-03-29

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

COMPLETED

Total Enrollment

1552 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-03-02

Brief Summary

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

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

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

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

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

Medicines Optimisation

Study Design

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

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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 College, London

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.

Cathy Geeson

Role: PRINCIPAL_INVESTIGATOR

University College, London

Locations

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

Luton and Dunstable University Hospital

Luton, Bedfordshire, United Kingdom

Site Status

Countries

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

United Kingdom

References

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

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.

Reference Type DERIVED
PMID: 28615279 (View on PubMed)

Other Identifiers

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

CDRF-2014-05-033

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

15/0525

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Use and Opinions of Care Home Medicines Audit Tools
NCT05133700 ENROLLING_BY_INVITATION