Clinical trial nurses seek recognition

As the number of trials has grown significantly in the past 20 years, so too has the demand for specialist nurses to collect data and co-ordinate participation. Linda Belardi speaks to one in the field.

The potential for today’s research to become tomorrow’s medicine and to change public health policy is an exciting prospect, says Elizabeth Hayles, a clinical trial nurse.

Switching from a background in paediatric nursing and midwifery, Hayles was attracted to the goal of achieving population-wide benefits and to influence ongoing health practices.

“As a nurse or a midwife you care one-on-one for the patient but in clinical trials you are looking at the whole population. Each person is like an individual thread of fabric which weaves together to form the big population picture. From there you can identify trends and hopefully improve evidence-based practice,” she says.

As a nurse and midwife working at the coalface for many years, Hayles, who works in Sydney, says she quickly identified gaps in knowledge but felt frustrated by an inability to address them.

It’s this long-term, broad population health perspective that saw her take up a position at the National Centre for Immunisation Research and Surveillance (NCIRS), where she now researches mothers’ attitudes to whooping cough and vaccination. She is also involved in a study that is investigating the possibility of vaccinating newborns for whooping cough in the first five weeks of birth.

“We know that Australia has the highest rates in the world for whooping cough, so if we can improve the control measures, we can actually protect those most vulnerable in society, which is our newborns. My focus is to be a voice for those who don’t have a voice and to raise the foundation of knowledge and practice for future generations.”

The longevity of the contribution that nursing research can make to population outcomes, Hayles says, is the best part of the role. “Nursing research doesn’t just impact one person but a whole population.”

While most clinical trials aim to identify new treatments and therapies, clinical trials occur within a wide range of clinical contexts, such as improving disease prevention, diagnosis, and around psychological wellbeing.

With a master’s degree in international public health, Hayles has a solid grounding in research and a passion for its role in society. To further advance her research career, Hayles has also embarked on a PhD investigating best practice communication for whooping cough recommendations to families at the time of birth.

While she is still interacting with mothers and newborns, working in this specialty requires a shift in perspective, she says. “As a nurse you are caring for a sick patient but as a clinical trial nurse you are asking healthy people to take part in clinical research and you are invited into the homes of families who share their amazing stories with you.”

Working in the community has its advantages but it also requires nurses to be more creative with fewer resources away from a hospital or clinical setting, she says.

Hayles says her role as a clinical trial nurse involves a unique mix of clinical skills, laboratory work and data entry. On home visits, she explains the goals of the research to study participants, takes blood samples if necessary, or implements questionnaires or educational interventions. One study has just begun using iPads to encourage the participation of new mothers in the research, which is proving to be popular with participants.

“On some visits you have to take blood or perform other procedures such as giving a vaccination but like nursing in the hospital setting, the work involves being meticulous with documentation. The laboratory aspect can involve spinning blood samples to separate the serum and then organising for that to be sent off to different labs.”

Hayles has also dipped her toe into writing, and has recently co-authored a paper on the attitudes of midwives to whooping cough that was published in the journal, Vaccine. Last month, Hayles won a new investigator’s award for a poster presentation she gave on the topic.

While the work might not involve following patients on their treatment journey, she says the role is still about caring and communicating with people to improve outcomes for the community. “I try to focus on each individual and each visit. It is still a family and you are still providing care. With some of questionnaires you have great chats with the participants and you can watch how patients respond to particular interventions.”

To thrive in the role, Hayles lists good communication as an essential skill. From talking through procedures with patients to communicating in academic circles, the ability to listen and communicate effectively is a key priority.

And it’s not just verbal or face-to-face communication, when conducting qualitative research being able to read body language or visual cues is very important, she says.

An ‘invisible’ specialty

However, despite the talent that this specialty attracts, questions have been raised about the need to raise its profile within the nursing workforce

Despite their contribution to improving patient care, a recent national survey of 67 clinical trial nurses in Australia found these nurses felt under-recognised by the profession.

The survey led by Lesley Wilkes, Professor of Nursing at the Clinical Nursing Research Unit at the University of Western Sydney, found that in general these nurses “felt undervalued, uneducated and not confident in their job positions, echoing the voice of similar nurses overseas.”

Currently, Australian clinical trial nurses are not a listed category on the Nursing and Midwifery Board’s database questionnaire and they have no set industrial classification, “contributing further to their invisibility in the nursing workforce,” Wilkes said of her findings to be published in an upcoming edition of Collegian.

Other professional issues identified by Wilkes involved having no formal educational preparation for the role, and minimal recognition in publications for nurses who had helped in the research that was published. Short-term contract work based on research grant funding could also disadvantage them.

Despite these issues, the survey found the role was complex and involved a range of tasks including protocol development, ethics approval applications, recruitment and consenting of participants in trials and administering or assisting with treatments.

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