Curriculum standards
Entrustable Professional Activities
LG4: Quality and clinical research
Quality and clinical research
Identify and address failures in health care delivery
This activity requires the ability to demonstrate measurement of health outcomes within quality and clinical research frameworks. Example activities include being able to:
- identify and report actual and potential (‘near miss’) errors
- conduct and evaluate system improvement activities
- adhere to best practice guidelines
- audit clinical guidelines and outcomes
- contribute to the development of policies and protocols designed to protect patients and enhance health care
- monitor one’s own practice and develop individual improvement plans
- recognise the role of clinical research and the associated potential benefits to patients and the community (clinical research may involve but is not limited to clinical trials and registry activities)
- contribute to the processes involved in generation and collection of clinical research data and use of clinical research protocols and reporting systems
Professional practice framework domain
Medical expertise
Ready to perform without supervision
Expected behaviours of a trainee who can routinely perform this activity without needing supervision
The trainee will:
- regularly review and use population health outcomes to identify opportunities for improvement in delivering appropriate care
- regularly review local patients to identify opportunities for improvement in delivering appropriate care
- identify opportunities for clinical research within their work setting
- identify clinical research that may be suitable and of benefit to their patients
- use standardised protocols to adhere to best practice and prevent the occurrence of wrong-site, wrong-patient procedures
- regularly monitor personal professional performance
- regularly review local treatment protocols to ensure compliance with national or international guidelines
- maintain Good Clinical Practice
(GCP) certification to participate
in clinical trials, including the:
- Health Research Council of New Zealand’s Research Ethics Guidelines
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for GCP
- National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research
- Therapeutic Goods Administration’s Australian clinical trial handbook
Requires some supervision
Possible behaviours of a trainee who needs some supervision to perform this activity
The trainee may:
- contribute to processes on identified opportunities for improvement
- recognise the importance of prevention and early detection in clinical practice
- use local guidelines to assist patient care decision making
- demonstrate awareness of clinical research and potential benefits to patients and the community
Communication
Ready to perform without supervision
Expected behaviours of a trainee who can routinely perform this activity without needing supervision
The trainee will:
- support patients to have access to, and use, easy-to-understand, high-quality information about health care decisions and outcomes
- support patients to share decision making about their own health care, to the extent they choose
- outline potential benefits and risks of involvement in clinical research, supporting informed decision making by patients
- liaise with clinical trials staff, and arrange timely referrals for patients to be screened for eligible trials
- assist patients’ access to their health information, as well as complaint and feedback systems
- discuss with patients any safety and quality concerns they have relating to their care
- implement the organisation’s open disclosure policy
Requires some supervision
Possible behaviours of a trainee who needs some supervision to perform this activity
The trainee may:
- demonstrate awareness of the evidence for consumer engagement and its contribution to quality improvement in health care
- apply knowledge of how health literacy might affect the way patients or populations gain access to, understand, and use health information
Quality and safety
Ready to perform without supervision
Expected behaviours of a trainee who can routinely perform this activity without needing supervision
The trainee will:
- demonstrate safety skills, including infection control, adverse event reporting, and effective clinical handover
- participate in organisational quality and safety activities, including morbidity and mortality reviews, clinical incident reviews, root cause analyses, and corrective action preventative action plans
- participate in clinical research safety processes, such as adverse event reporting
- demonstrate awareness of EVOLVE recommendations in their work and health services
- participate in systems for surveillance and monitoring of adverse events and ‘near misses’, including reporting such events
- ensure that identified opportunities for improvement are raised and reported appropriately
- use clinical audits and registries of data on patients’ experiences and outcomes, learnings from incidents, and complaints to improve care
Requires some supervision
Possible behaviours of a trainee who needs some supervision to perform this activity
The trainee may:
- demonstrate awareness of a systematic approach to improving the quality and safety of health care
- demonstrate awareness of the role clinical research plays in advancing the quality and range of health care options available to patients and the community
Teaching and learning
Ready to perform without supervision
Expected behaviours of a trainee who can routinely perform this activity without needing supervision
The trainee will:
- translate quality improvement approaches and methods into practice
- participate in professional training in quality and safety to ensure a contemporary approach to safety system strategies, including maintenance of GCP certification
- supervise and manage the performance of junior colleagues in the delivery of high-quality, safe care
Requires some supervision
Possible behaviours of a trainee who needs some supervision to perform this activity
The trainee may:
- work within organisational quality and safety systems for the delivery of clinical care
- use opportunities to learn about safety and quality theory and systems
Research
Ready to perform without supervision
Expected behaviours of a trainee who can routinely perform this activity without needing supervision
The trainee will:
- demonstrate awareness of the ethical framework that governs clinical research in Australia and New Zealand
- ensure that any protocol for human research is approved by a human research ethics committee, in accordance with the national statement on ethical conduct in human research
- undertake appropriate certification to participate in clinical research in their own institution
- select studies based on optimal trial design, freedom from bias, and precision of measurement
- evaluate the value of treatments in terms of relative and absolute benefits, cost, potential patient harm, and feasibility
- evaluate the applicability of the results of clinical studies to the circumstances of individual patients, especially those with multiple comorbidities
- specify research evidence to the needs of individual patients
Requires some supervision
Possible behaviours of a trainee who needs some supervision to perform this activity
The trainee may:
- recognise that patient participation in research is voluntary and based on an appropriate understanding about the purpose, methods, demands, risks, and potential benefits of the research
Cultural safety
Ready to perform without supervision
Expected behaviours of a trainee who can routinely perform this activity without needing supervision
The trainee will:
- undertake professional development opportunities that address the impact of cultural bias on health outcomes
- incorporate appropriate LGBTQIA+ safe language, including gender affirming language
Requires some supervision
Possible behaviours of a trainee who needs some supervision to perform this activity
The trainee may:
- communicate effectively with patients from culturally and linguistically diverse backgrounds
Ethics and professional behaviour
Ready to perform without supervision
Expected behaviours of a trainee who can routinely perform this activity without needing supervision
The trainee will:
- align improvement goals with the priorities of the organisation
- contribute to developing an organisational culture that enables and prioritises patients’ safety and quality of care
- ensure that patients’ decisions to participate in clinical trials are informed and unbiased
Requires some supervision
Possible behaviours of a trainee who needs some supervision to perform this activity
The trainee may:
- comply with professional regulatory requirements and codes of conduct
Judgement and decision making
Ready to perform without supervision
Expected behaviours of a trainee who can routinely perform this activity without needing supervision
The trainee will:
- use decision-making support tools, such as guidelines, protocols, risk prediction tools, pathways, and reminders
- analyse and evaluate current care processes to improve care
Requires some supervision
Possible behaviours of a trainee who needs some supervision to perform this activity
The trainee may:
- access information and advice from other health practitioners to identify, evaluate, and improve patients’ care management
Leadership, management, and teamwork
Ready to perform without supervision
Expected behaviours of a trainee who can routinely perform this activity without needing supervision
The trainee will:
- formulate and implement quality improvement strategies as a collaborative effort, involving all key health professionals
- actively involve clinical pharmacists in the medication-use process
- support multidisciplinary team activities to lower patients’ risk of harm, and promote interdisciplinary programs of education
- actively involve clinical research staff, such as nurses and research assistants, in clinical research implementation and conduct
Requires some supervision
Possible behaviours of a trainee who needs some supervision to perform this activity
The trainee may:
- demonstrate attitudes of respect and cooperation among members of different professional teams
- partner with clinicians and managers to ensure patients receive appropriate care and information on their care
Health policy, systems, and advocacy
Ready to perform without supervision
Expected behaviours of a trainee who can routinely perform this activity without needing supervision
The trainee will:
- recognise all aspects of the development, implementation, evaluation, and monitoring of governance processes in routine clinical care and in clinical research activities
- regularly participate in multidisciplinary meetings on quality clinical care, ethical clinical research, and patient and workplace safety
- measure, analyse, and report a set of specialty-specific process of care and outcome clinical indicators, and a set of generic safety indicators
- take part in the design
and implementation of the
organisational systems for:
- clinical education and training
- defining the scope of clinical practice
- performance monitoring and management
- safe chemotherapy practice
- safety and quality education and training
Requires some supervision
Possible behaviours of a trainee who needs some supervision to perform this activity
The trainee may:
- maintain a dialogue with service managers about issues that affect patients’ care
- contribute to relevant organisational policies and procedures
- help shape an organisational culture that prioritises safety and quality through openness, honesty, learning, and quality improvement