NursingFCCNCT07740369
An Exploration of Family Centred Care (FCC) in UK Inpatient Wards
An observational study of Nursing and Family Centered Care, run by Milton Keynes University Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nursing, Family Centered Care, Ethics Nursing
- What is being tested?
- Semi-structured qualitative interview
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Jul 2026to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be selected from adult inpatient medical wards at Milton Keynes University Hospital. The study population will comprise 3 groups: patients receiving inpatient medical care, family members involved in the care of patients admitted to these wards, and registered nurses working within the same clinical setting. Participants will be recruited using purposive sampling to obtain relevant perspectives on family involvement in inpatient care, nursing practice and associated ethical and cultural issues. Recruitment will take place through clinical teams, nursing leads and study advertisements displayed in relevant patient and staff areas.
Who may be able to join
- Age:
- 18 years or older
- Role: Must fall into one of the following categories:
- A patient admitted to an internal medicine ward
- A family member of a patient admitted to an internal medicine ward
- A registered nurse working on an internal medicine ward
- Capacity:
- Able and willing to provide informed consent
Who cannot join
- Are under 18 years of age
- Are unable to provide informed consent
- Are unable to participate in study interviews (e.g., due to cognitive, linguistic, or medical limitations)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Milton Keynes University Hospital
Milton Keynes, Buckinghamshire, MK6 5LD
Soma Hajdu, MSc, 01908996744, soma.hajdu@mkuh.nhs.uk
research@mkuh.nhs.uk
About this study
Official title: Balancing Family and Ethics: An Exploration of Family Centred Care in UK Inpatient Wards
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Nursing, Family Centered Care, Ethics Nursing, Family Nursing
- Being tested
- Semi-structured qualitative interview
- Keywords
- Family-centred care, Family involvement, Nursing ethics, Patient autonomy, Shared decision-making, Qualitative interviews, Informed consent, Culturally sensitive care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured qualitative interviewOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients admitted to an internal medicine ward Receives: Other: Semi-structured qualitative interview | |
| Carers | Family members of patients admitted to an internal medicine ward Receives: Other: Semi-structured qualitative interview | |
| Professionals | Registered nurses working on an internal medicine ward Receives: Other: Semi-structured qualitative interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Themes Describing Experiences and Perceptions of Family Involvement in Inpatient Care
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.
Measured: At the participant's single study interview following enrolment. The interview timing relative to the relevant inpatient episode is not prespecified.
Secondary outcomes (3)
Themes Describing Ethical Tensions Associated With Family Involvement in Inpatient Care
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.
Measured: At the participant's single study interview following enrolment. The interview timing relative to the relevant inpatient episode is not prespecified.
Themes Describing Cultural Influences on Expectations of Family Involvement
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.
Measured: At the participant's single study interview following enrolment. The interview timing relative to the relevant inpatient episode is not prespecified.
Themes Describing Nursing Communication and Management of Family Involvement
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.
Measured: At the participant's single study interview following enrolment. The interview timing relative to the relevant inpatient episode is not prespecified.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start24 Jul 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NursingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton Keynes University Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740369
- Sponsor's protocol ID
- MKUH-RD-029
- Other IDs
- 372394, 26/SC/0237, 209512
- Acronym
- FCC
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data publicly available to other researchers. The study involves qualitative interview data that may contain detailed contextual information, and access will therefore be limited to the study team in accordance with the approved protocol and participant consent. Anonymised data may be shared with the named research team conducting the corresponding study in Israel for the planned comparative analysis, but this is not a general IPD-sharing arrangement.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balancing Family and Ethics: An Exploration of Family Centred Care in UK Inpatient Wards
- ClinicalTrials.gov ID
- NCT07740369
- Acronym / sponsor ID
- FCC / MKUH-RD-029
- Conditions
- Nursing, Family Centered Care, Ethics Nursing, Family Nursing
- Keywords
- Family-centred care, Family involvement, Nursing ethics, Patient autonomy, Shared decision-making, Qualitative interviews, Informed consent, Culturally sensitive care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Milton Keynes University Hospital NHS Foundation TrustOther government
- Study start
- 24 Jul 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Semi-structured qualitative interviewPatients admitted to an internal medicine ward |
| Carers | – | Other: Semi-structured qualitative interviewFamily members of patients admitted to an internal medicine ward |
| Professionals | – | Other: Semi-structured qualitative interviewRegistered nurses working on an internal medicine ward |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be selected from adult inpatient medical wards at Milton Keynes University Hospital. The study population will comprise 3 groups: patients receiving inpatient medical care, family members involved in the care of patients admitted to these wards, and registered nurses working within the same clinical setting. Participants will be recruited using purposive sampling to obtain relevant perspectives on family involvement in inpatient care, nursing practice and associated ethical and cultural issues. Recruitment will take place through clinical teams, nursing leads and study advertisements displayed in relevant patient and staff areas.
Key inclusion criteria (8 listed)
- 18 years or older
- A patient admitted to an internal medicine ward
- A family member of a patient admitted to an internal medicine ward
- A registered nurse working on an internal medicine ward
- Able and willing to provide informed consent
Key exclusion criteria (3 listed)
- Are under 18 years of age
- Are unable to provide informed consent
- Are unable to participate in study interviews (e.g., due to cognitive, linguistic, or medical limitations)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-structured qualitative interviewEach 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. | Other | Carers, Patients, Professionals |
Primary outcome
Themes Describing Experiences and Perceptions of Family Involvement in Inpatient Care
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.
3 secondary outcomes
Themes Describing Ethical Tensions Associated With Family Involvement in Inpatient Care
Time frame: At the participant's single study interview following enrolment. The interview timing relative to the relevant inpatient episode is not prespecified.
Themes Describing Cultural Influences on Expectations of Family Involvement
Time frame: At the participant's single study interview following enrolment. The interview timing relative to the relevant inpatient episode is not prespecified.
Themes Describing Nursing Communication and Management of Family Involvement
Time frame: At the participant's single study interview following enrolment. The interview timing relative to the relevant inpatient episode is not prespecified.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data publicly available to other researchers. The study involves qualitative interview data that may contain detailed contextual information, and access will therefore be limited to the study team in accordance with the approved protocol and participant consent. Anonymised data may be shared with the named research team conducting the corresponding study in Israel for the planned comparative analysis, but this is not a general IPD-sharing arrangement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nursing and Family Centered Care, run by Milton Keynes University Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louise E Mew, PhD, BSc Adult Nursing (01908995116, Louise.Mew@mkuh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Themes Describing Experiences and Perceptions of Family Involvement in Inpatient Care (time frame: At the participant's single study interview following enrolment. The interview timing relative to the relevant inpatient episode is not prespecified.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.