Milton Keynes University Hospital
Milton Keynes, Buckinghamshire, MK6 5LD, United Kingdom
Location status: Recruiting
Location contact
Louise E Mew, PhD
PRINCIPAL_INVESTIGATOR
Soma Hajdu, MSc
CONTACT
Teena Babu, Masters
SUB_INVESTIGATOR
CONTACT
NCT Number: NCT07740369
This qualitative study will explore how family-centred care is understood and experienced in adult inpatient medical wards in the UK. Family-centred care involves including a patient's family in care and discussions where appropriate. Although family involvement can improve communication, emotional support and shared decision-making, it may also create ethical challenges where family wishes differ from the patient's preferences or clinical judgement.
The study will recruit 30 adults at Milton Keynes University Hospital: 10 patients admitted to an internal medicine ward, 10 family members of patients admitted to an internal medicine ward and 10 registered nurses working on an internal medicine ward. Each participant will take part in one semi-structured interview lasting approximately 30-60 minutes, conducted face to face, by telephone or by video call.
The study is based on the expectation that patients, family members and nurses may experience family involvement differently, and that cultural values may influence how family-centred care is applied in practice. The interviews will explore issues including privacy, informed consent, patient autonomy and decision-making. The UK findings will also be compared with findings from an identical study being conducted in Israel to examine how cultural and value-based contexts may affect family involvement in hospital care.
The findings may help identify practical communication approaches for delivering culturally sensitive family-centred care while protecting patients' rights and supporting nurses' professional responsibilities.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Milton Keynes, Buckinghamshire, MK6 5LD, United Kingdom
Location status: Recruiting
Louise E Mew, PhD
PRINCIPAL_INVESTIGATOR
Soma Hajdu, MSc
CONTACT
Teena Babu, Masters
SUB_INVESTIGATOR
CONTACT
The observational study model is a cross-sectional, multi-perspective qualitative interview design involving patients, family members and registered nurses.
This is a single-centre, multi-perspective qualitative study examining how family-centred care is understood and implemented in adult internal medicine wards at Milton Keynes University Hospital. The study focuses on the ethical and cultural tensions that may arise when family involvement intersects with patient autonomy, privacy, informed consent, clinical judgement and nurses' professional responsibilities under the Nursing and Midwifery Council Code.
A purposive sampling approach will be used to obtain perspectives from patients, family members and registered nurses. Data will be collected through individual semi-structured interviews conducted face to face, by telephone or by video call, according to participant preference. The interview guide will use open-ended questions informed by the literature, subject-matter expertise and Patient and Public Involvement and Engagement. Interviews will be audio-recorded with consent and transcribed verbatim.
Interview data will be analysed thematically using the Braun and Clarke framework. The analysis will follow an inductive and constructivist approach and will include familiarisation with the data, coding, development and review of themes, and definition of the final thematic structure. This approach is intended to capture differences and similarities between the perspectives of patients, relatives and nurses and to identify recurring ethical, cultural and practical issues associated with family involvement in inpatient care.
Audio recordings and transcripts will be handled in accordance with Milton Keynes University Hospital data protection and research governance requirements. Transcripts will be anonymised, and names, wards, departments, places of work and other potentially identifying details will be removed or changed where possible. Identifiable information will be stored separately from research data on secure NHS systems. Audio recordings will be deleted at the end of the study.
Anonymised findings from the UK study will be compared with findings from an identical study being undertaken at Rabin Medical Centre-Beilinson Hospital in Israel. The comparison will explore how different cultural and value-based contexts, particularly individualist and collectivist perspectives, may influence family-centred care. No identifiable participant information will be shared with the Israeli research team. The study is intended to support the development of a conceptual understanding of family-centred care and practical communication approaches for culturally sensitive nursing practice.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Age:
Role: Must fall into one of the following categories:
Capacity:
Exclusion criteria
Each participant will complete one individual semi-structured interview lasting approximately 30-60 minutes. Interviews will be conducted face to face, by telephone or by video call according to participant preference. Open-ended questions will explore experiences and views of family involvement in inpatient care, including issues relating to privacy, informed consent, patient autonomy and decision-making. With consent, interviews will be audio-recorded and transcribed verbatim. Participants may decline to answer any question or stop the interview at any time.
Time frame: At the participant's single study interview following enrolment. The interview timing relative to the relevant inpatient episode is not prespecified.
Semi-structured interview transcripts will be analysed thematically using the Braun and Clarke framework. Themes and subthemes will describe how patients, family members and registered nurses perceive and experience family involvement in inpatient care, including the family's role, the perceived benefits and challenges of involvement, involvement in care and decision-making, and responses from nursing staff. This is a qualitative outcome and no numerical scale or score will be used.
Time frame: At the participant's single study interview following enrolment. The interview timing relative to the relevant inpatient episode is not prespecified.
Interview transcripts will be analysed to identify themes and subthemes concerning ethical tensions associated with family involvement. These may include patient autonomy, confidentiality, privacy, justice, patient welfare, professional decision-making and situations where family or cultural expectations conflict with the patient's wishes, professional ethics or the needs of the ward.
Time frame: At the participant's single study interview following enrolment. The interview timing relative to the relevant inpatient episode is not prespecified.
Interview transcripts will be analysed to identify themes and subthemes describing how cultural background and values influence expectations regarding the family's role, participation in care, communication with healthcare professionals and involvement in decision-making.
Time frame: At the participant's single study interview following enrolment. The interview timing relative to the relevant inpatient episode is not prespecified.
Interview transcripts will be analysed to identify themes and subthemes concerning how nurses respond to family involvement, manage conflict between professional and cultural values, communicate with patients and families, and mediate between professional responsibilities and the patient's cultural or family context.
Contact information is provided by the study sponsor or research team.
Louise E Mew, PhD, BSc Adult Nursing
CONTACT
Teena Babu, Masters in nursing
CONTACT
Milton Keynes University Hospital NHS Foundation Trust
Other Gov
Balancing Family and Ethics: An Exploration of Family Centred Care in UK Inpatient Wards
Acronym: FCC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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