跳至主要内容
临床试验/NCT07663058
NCT07663058尚未招募不适用

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

Guy's and St Thomas' NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年8月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Recruitment of CRNs and Research-Patients

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Clinical Research Nurses (CRN Group)

CRNs working in adult clinical research

干预措施: Interviews (Other)

Clinical Research Nurses (CRN Group)

CRNs working in adult clinical research

干预措施: Non-participant observations (Other)

Research-Patients

Research-patients currently participating or have previously participated in adult clinical research at the age of 18 (or over)

干预措施: Interviews (Other)

Research-Patients

Research-patients currently participating or have previously participated in adult clinical research at the age of 18 (or over)

干预措施: Non-participant observations (Other)

结局指标

主要结局

Recruitment of CRNs and Research-Patients

时间窗: End of recruitment date is 30 Dec 2028

Recruitment of up to 15 CRNs and up to 15 research-patients for interviews

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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