NCT07740369

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
24mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Jul 2026Jun 2028

Study Start

First participant enrolled

July 24, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

1.9 years

First QC Date

July 27, 2026

Last Update Submit

July 30, 2026

Conditions

Keywords

Family-centred careFamily involvementNursing ethicsPatient autonomyShared decision-makingQualitative interviewsInformed consentCulturally sensitive care

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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

    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

    At the participant's single study interview following enrolment. The interview timing relative to the relevant inpatient episode is not prespecified.

Study Arms (3)

Patients

Patients admitted to an internal medicine ward

Other: Semi-structured qualitative interview

Carers

Family members of patients admitted to an internal medicine ward

Other: Semi-structured qualitative interview

Professionals

Registered nurses working on an internal medicine ward

Other: Semi-structured qualitative interview

Interventions

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.

CarersPatientsProfessionals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Milton Keynes University Hospital

Milton Keynes, Buckinghamshire, MK6 5LD, United Kingdom

RECRUITING

Central Study Contacts

Louise E Mew, PhD, BSc Adult Nursing

CONTACT

Teena Babu, Masters in nursing

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2026

First Posted

July 31, 2026

Study Start

July 24, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

July 31, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.

Locations