A Randomised Controlled Trial of Computerised Decision Support System for Breast MDM
As medical knowledge and research continues to grow, the demands on those who are required to deliver consistent, high quality and safe care is becoming increasingly difficult to meet unaided. Organizations like the National Institute for Clinical Excellence are trying to bridge the gap between best evidence and practice by developing up to date clinical guidance which is evidence based. However the uptake of these guidelines into the clinical practice is low suggesting the need for methods for better implementation. Among the most promising new developments in the health information technology is point-of-care information and decision support system that may help to reduce the burdens on healthcare professionals..
This study aims to investigate the impact of one such clinical decision support system on the quality of care of women with breast disease. The Multi-disciplinary meeting Assistant and Treatment sElector (MATE) decision support tool is a computerised system designed to assist breast clinicians in making management decisions for their patients in breast Multi Disciplinary Meetings. MATE evaluates patient’s clinical facts and suggests optimal management options according to high quality evidence based clinical guidelines. However these suggestions are not binding and the final decision is taken by the clinicians who can override system suggestions. The researchers are investigating whether MATE can improve the clinician's compliance with guidelines. Additionally, the system will ensure that clinicians are reminded if the patient is eligible to take part in any national clinical trials.
This is a single-centre two-arm, randomised controlled trial. An informed consent will be obtained from eligible patients above 18 years, who understand written and spoken English. The consent will be obtained by either a clinician or a research nurse who are trained in obtaining consent. Eligible cases referred to breast MDM will be randomly allocated to either the intervention (decision support enabled) and comparison (decision support disabled) arm. Both arms will use MATE to capture, present and store all relevant patient data. In addition to that, in decision support enabled arm, MATE will provide an active decision support to the MDT clinicians by suggesting appropriate management options in accordance with the clinical guidelines. In decision support enabled arm, no decision recommendations will be shown to the MDT members while system keeping record of its recommendations.
The MATE decision support system will not interfere with the meeting routine and will utilise one of the two available multimedia screens in the MDM room to present data and decision recommendations, while the other screen will be available to carry out routine MDM procedures.
Around 233 cases in each arm will be required to give sufficient statistical power. The trial period of 12 months should be sufficient to provide required case number.
The study will require minimal resources from the host organization in terms of time and personnel. The possible risks to the participating patients are primarily limited to data confidentiality (See below)
Data confidentiality: Existing measures such as data encryption, collection of minimal identifiable data, stringent data access policy and robust security measures used in MATE will ensure confidentiality and integrity of patient data. A good clinical practice will be followed through out the life of trial.
The study results will inform both the medical and health informatics community. If benefits are found, the implications are far reaching and the generic nature of underlying decision support technology will allow the easy adaptation of this tool for other types of cancer.
The following diagram provides the overview of the trial structure.
MATE RCT structure
