Research-patientS and Clinical researcH Nurses: Exploring Their Experiences of tAking paRt in Clinical resEarch in the NHS

Обзор

This PhD explores the views of clinical research nurses (CRNs) and research-patients as they take part in clinical research within their respective roles, i.e., as a specialised staff member and as a patient volunteer. Clinical research is supported by NHS England as the best way to improve patient care by finding out whether a new treatment is better than what is available. CRNs are specialist nurses who manage and coordinate clinical research. CRNs are responsible for the safe running of research; they ensure the right information is collected for the research/trial to be successful. CRNs support the well-being of research-patients, by taking note of any new, or existing healthcare needs of research-patients while they take part in research. CRNs coordinate the activities that research requires, biological samples, scans, documentation. Balancing their responsibility towards research-patients, on the one hand, and research management, on the other, can bring unique challenges for the CRN. CRNs can feel conflicted between these two responsibilities, e.g., when they think that a drug trial, or the research activities in a study is at odds with the research-patient's best interest despite the research-patient's consent to take part in research. CRNs are tasked with maintaining/facilitating recruitment of research-patients, this can be a challenging aspect of their role especially if they feel pressured to approach patients to take part in research. Currently, we know little about how CRNs balance these two responsibilities, or what other problems CRNs have in their everyday role when balancing these responsibilities. Finding out more about these aspects of the CRN role is important because it may not only improve job experience but can also give a better understanding of what can be changed to improve how CRN perform their role which could ultimately improve research-patients' experience of taking part in research. To address this issue, this PhD will explore CRNs and research-patients' views about clinical research, the challenges CRNs face, how CRNs balance their responsibilities, and what role does the relationship between CRNs, and research-patients play overall in what they say about their experience of taking part in clinical research. The researcher will interview and shadow CRNs and research-patients at a central NHS Hospital. This is a LISS/ESRC funded PhD at King's College London and supported by Guy's and St Thomas NHS Foundation Trust.

Подробное описание

The purpose of this study is to explore how research patients and Clinical Research Nurses (CRNs) describe their experiences of participating in clinical research within their respective roles.

The study involves two main activities:

1. Interviewing CRNs and research-patients via online (separately). Semi-structured interviews will be conducted using an interview guide based on themes identified in the existing literature. The guide will be refined and finalised based on feedback from Patient and Public Involvement and Engagement (PPIE), as discussed in the PPI section of the IRAS application. 2. Observations of research activities at research departments including research consultations between CRNs and research-patients.

Research activities refer to various assessments or tasks carried out to generate data for a research protocol. The CRN's role includes conducting these activities, which may involve obtaining patient consent, collecting biological samples (e.g., blood, urine), or dispensing experimental drugs as part of a clinical trial. These activities typically occur during 'research visits' which are appointments or consultations between the CRN and the research patient.

The researcher will observe research activity taking place in research departments by way of "observer placements" for up to five days. Placements can occur in any of the following research departments: gastrointestinal, liver, surgical, respiratory, diabetes and endocrinology, neurology, renal, gynaecology, rheumatology, cardiovascular imaging, and lupus, ageing and health. This wide range of departments has been intentionally selected to provide a broad perspective and to maximise exposure to diverse research activities across different disease specialities. These observation placements will allow the researcher to directly observe interactions between CRNs and research-patients during research activities. Observational data will provide insight into the real-world context in which CRNs and research patients communicate their understandings, expectations, and perceptions of research participation.

Combining observational data with interview data will support triangulation during reflexive thematic analysis.

The number of placements will depend on the opportunities available for the researcher to undertake observations during the PhD data collection period. While the total number of observations is flexible, it is anticipated that this will be in the region of 10-15 due to the overall timeline for completing the PhD. The final number will be informed by guidance from the academic supervisory team during the analysis phase, which will take place concurrently with ongoing data collection. The sample size will be guided by the principle of 'information power'.

Organisation of the observer placements within research departments will be supported by the research leads (research matrons) with whom the researcher has already made prior contact, discussed the aim of the study, and who are supportive and will help to facilitate the project's objectives.

Вмешательства

• Другое Interviews
  Semi-structured interviews
• Другое Non-participant observations
  Non-participant observations of clinical research visits

Первичные конечные точки

• Recruitment of CRNs and Research-Patients [Срок оценки: End of recruitment date is 30 Dec 2028]

Критерии участия

Критерии включения

INCLUSION CRITERIA FOR RESEARCH-PATIENTS

• Research-patients aged above 18 years old.
• Research-patients currently participating or have previously participated in adult clinical research at the age of 18 (or over) at GSTT.
• Research-patients who are willing and able to provide informed consent.

INCLUSION CRITERIA FOR CRNS Clinical research nurses (CRNs) currently working in adult clinical research at Guys and St Thomas' NHS Foundation Trust.

• CRN willing and able to give consent.

Критерии исключения

EXCLUSION CRITERIA FOR RESEARCH-PATIENTS

• Patients who showed an interest in taking part in research but were not recruited, e.g. due to screen failure, or ineligibility.
• Research-patients recruited to research via proxy consent, e.g., next of kin.
• Patients unable to provide informed consent, e.g., lacking mental capacity.
• Research-patients considered vulnerable or at risk of harm, by the research team
• Research-patients taking part in mental health or maternity trials or studies
• Research-patients not fluent in English or not able to converse well in English

EXCLUSION CRITERIA FOR CRNS

• Clinical research midwives and clinical research nurses working in mental health, maternity, and paediatric research are excluded from this study.
• CRNs not willing or unable to give consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Великобритания · 1 центр

• Guy's and St Thomas' NHS Foundation Trust — London

Идентификаторы

NCT: NCT07663058 · 334182

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗