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FrailtyI4FNCT06504641

I4F: Isla for Frailty Feasibility Study

An observational study of Frailty, run by Imperial College London at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

BACKGROUND: Older patients with frailty have complex support needs. How they manage with daily tasks such as eating and drinking, mobilising, communicating their preferences, and the level of support they need, can vary on a day-to-day basis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Frailty
What is being tested?
Isla for Frailty
How many people
95 participants
Where
1 siteUnited Kingdom
Study dates
14 Feb 2024to 30 Sep 2024
Phase
Observational
Are there results?
None posted in the registry

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
  • Adult, Older adult

Study population: Patients: Adults, aged 65 years or older, who are frail or pre-frail, and who are admitted as an inpatient to an acute Medicine for the Elderly ward during a three-month pilot phase Carers: Carers of enrolled patients, who provide the enrolled patient with assistance in their daily activities and are unpaid for these caring activities. A carer may be a member of the patient's family, a friend, or other person who provides the patient with unpaid care Ward team: Clinical staff working on one of three Medicine for the Elderly wards at St Mary's Hospital, where the Isla for Frailty intervention (described above) will be subject to a feasibility trial

Who may be able to join

  • Admitted as an inpatient to an acute Medicine for the Elderly ward at St Mary's Hospital during a 3-month pilot phase of Isla's visual record platform
  • Aged ≥65 years old
  • Are considered to be frail or pre-frail by the direct care team
  • Have capacity to consent to study participation OR lack capacity to consent on the condition that a 'personal consultee' is available to advise on the patient's likely wishes and feelings about taking part.
  • Aged ≥18 years
  • Provide the patient/care-recipient with assistance in their daily activities and are unpaid for these caring activities
Show all 11Show fewer
  • Are willing to participate in an interview as part of the study
  • A carer may be a member of the patient's family, a friend, or other person who provides the patient with unpaid care
  • Clinical staff working on an acute Medicine for the Elderly ward at St Mary's Hospital.
  • Staff must be working regular shifts on the ward during study initiation and pilot phases
  • Staff must have an active nhs.net account.

Who cannot join

  • Patients who lack capacity to consent will be excluded if a personal consultee is not available to advise on the patients' likely wishes or feelings about taking part.
  • Carers.
  • Carers will be excluded if the patient/care-recipient declined to participate in the study
  • Ward team.
  • Ad-hoc bank/agency staff
  • Permanent staff on long-term leave (e.g. sick/maternity) during the pilot

Trial locations and contacts

1 site in 1 country.

Phoebe Averill, PhD contact

020 7594 9038

phoebe.averill@nhs.net

Erik Mayer, PhD FRCS contact

e.mayer@imperial.ac.uk

United Kingdom1 site, 1 recruiting
  • St Mary's Hospital

    London, W2 1NY

    Susannah Long, Susannah.long2@nhs.net

    Recruiting

Other trials in United Kingdom

About this study

Official title: Acceptability, Feasibility, and Potential Effectiveness of Video-based Patient Records for Supporting Care Delivery for Older People With Frailty.

BACKGROUND: Older patients with frailty have complex support needs. How they manage with daily tasks such as eating and drinking, mobilising, communicating their preferences, and the level of support they need, can vary on a day-to-day basis. They are at risk of rapid loss of functional independence when they are acutely unwell. When older people need input from multiple different professionals, ineffective communication is sadly very common. This leads to disjointed care, and patients becoming frailer and suffering avoidable health complications. One of the problems is that it can be difficult for healthcare professionals to build up a complete picture of a patient from brief verbal handovers and written information in medical records. It is believed that video-recordings capturing the changing functional abilities and support needs of individual patients could improve care-provider communication and support for older people. Smartphones with cameras are now a part of everyday life, and people often tell their stories using photographs and videos. However, video recording patients during care delivery is not commonplace. It is not know how patients and carers feel about being video recorded or whether video recordings improve care.

AIM: To explore the perspectives of frail older patients, carers, and clinical staff around video recording during routine clinical care, and to understand how patient videos could impact on communication and care delivery across care transitions.

METHODS: The study team will recruit frail, older inpatients, their carers, and clinical staff from a Medicine for the Elderly ward. Over three months, doctors, nurses, and therapists will securely record and view patient videos alongside providing usual care. Videos will capture patients' functional abilities and support needs to inform ongoing assessment and care delivery. The investigators will collect information from patients/ carers/ doctors/ nurses /therapists about their experiences of the video recording intervention through interviews and questionnaires.

Read the detailed description

Around 10% of people aged over 65 years have frailty, rising to nearly 50% of those aged over 85 years, and frailty prevalence is expected to increase alongside the growth of the ageing population.

Older people with frailty commonly require input from multiple professionals across primary, secondary, and social care. Professional bodies including the British Geriatrics Society have advocated for responsible information sharing to ensure that older people with frailty are supported to age well. Yet, as patients move between different parts of the health and care service, communication between different professionals and different providers is frequently ineffective, assessments are duplicated, and carers are repeatedly asked to provide the same information. Poorly coordinated care is linked to avoidable complications, accelerated deconditioning, and loss of independence, as well as greater carer burden and increased costs to health and social care.

Much communication across professional and organisational boundaries takes place through written referrals and (increasingly) through shared electronic patient records. Electronic health records (EHRs) are voluminous, containing large quantities of unstructured text. This plethora of data, combined with variability in documentation practices and the propagation of erroneous information in the record, means clinicians face significant challenges retrieving information to support clinical assessment. Excessive time spent in the EHR system is known to be a major source of clinician dissatisfaction contributing to stress and burnout, but failure to retrieve relevant information can lead to medical errors and poor quality care. Moreover, while text is appropriate for communicating certain types of clinical information (for example, diagnoses, comorbidities, prescribed medications, allergies, etc), it is difficult to discern the nuances of a frail older patient's condition in relation to aspects such as functional ability, cognition, behavioural symptoms, and support needs from text narratives alone. Receiving professionals may be left wondering 'Is this normal for this patient?' It is vital that health and care professionals can recognise and track subtle changes to proactively manage avoidable deconditioning and deliver individualised, person-centred care. More sophisticated modes of documentation and communication are needed to improve patient assessment and care continuity across transitions of care.

In an age of smartphones, people are increasingly telling their stories using photographs and video recordings.Technological advances allow for a variety of video recording applications in healthcare but in practice these have largely been largely confined to research, education, and quality improvement. Researchers value the richness of video data that includes sound, environmental context, body language and facial expressions, thus facilitating objective, accurate documentation of behaviour. In medical education, video-recordings assist clinicians in recognising visual and auditory clues during clinical consultations that cannot be derived from text-based learning. Video-based surgical records have informed quality improvement initiatives through the provision of increased detail and nuance beyond what exists in written operative notes alone. A further clear advantage of video recording is the creation of a permanent visual patient record that can be reviewed repeatedly by multiple professionals, ultimately increasing the accuracy of clinical assessment and improving communication among multi-professional healthcare workers.

Nevertheless, ethico-legal concerns and patient confidentiality have historically limited the use of video-recording for direct care purposes. Early studies suggested that patients can feel censored or self-conscious in front of a camera and video recording can have a detrimental impact on the therapeutic relationship. However, over the last decade, the proliferation of smartphones had led to video recordings being captured in everyday life, and technological advances are supporting lawful collection, handling, and storage of visual data to protect people's privacy in line with data protection legislation.

Little is known about how video recordings can support the safety and quality of individual patient care. Members of the study team recently conducted a systematic review to explore use of video-recording patients for direct care purposes. Twenty-seven studies published in the last 10 years were identified, evaluating acceptability, effectiveness, and/or ethico-legal considerations associated with video-recording patients to support care delivery. The review also brought together key guidance and recommendations of professional and regulatory bodies in the UK relating to audio-visual recording in healthcare. Evidence suggests that video recording patients for direct care purposes may be acceptable to patients and professionals, providing that the benefits are clear and risks are properly mitigated. Video technologies have been piloted in a variety of different health and care contexts to support diagnosis, care, and treatment, however, no studies have examined the application of video-based patient records for supporting older people's care transitions. Furthermore, the extent to which video recording is effective in support direct patient care remains unclear due the small number of published studies and poor quality of existing evidence.

Video recordings could enhance the safety and quality of care transitions for older people with frailty through providing objective and richly detailed visual information about their functional capabilities, support needs, and care preferences. However, making and sharing patient video recordings raises important ethical and legal considerations that must be addressed to enable the practical application of video for direct care purposes. This study will explore the acceptability, feasibility, and potential effectiveness of embedding in the electronic patient record, video recordings captured during routine care.

A programme theory (below), developed by our multidisciplinary steering group and informed by national frailty policy, suggests how video-based patient records could lead to patient benefit.

Programme Theory

If (1) it were acceptable and feasible to video-record frail, older patients, capturing their functional abilities, support needs, and care preferences at key timepoints (e.g. hospital discharge), and (2) the video-recordings were available for view by all those assessing/caring for the person across primary/secondary/community settings,

Then (3) A shared understanding of the person's functional abilities and support needs could be created, (4) A longitudinal view of the patient's function could be visualised, (5) Communication during patient handovers/at care interfaces could be improved,

So that (6) Older people with frailty receive care that is more person-centred and joined up, (7) Deterioration of frailty status is recognised and act upon earlier, (8) Improvements in care delivery can be achieved in line with the NHS Long Term Plan and the NHS RightCare Frailty Toolkit

So that (9) Older people with frailty suffer less avoidable complications and spend less time in hospital when they don't need to be there, and (10) Older people's experiences of care and health outcomes can be improved.

Conditions
Frailty
Being tested
Isla for Frailty
Keywords
Frailty, Communication, Patient assessment, Video-recording, Care transitions, Care continuity
Medical subject headings
Frailty, Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Isla for FrailtyOther

    Isla for Frailty - video-based patient records. Isla is a technology company providing a visual patient record platform. The platform allows anyone involved in a patient's care to capture and review visual data (photographs, videos) relating to a patient's health. The platform is web-based (a "progressive web application") and supports secure capture of visual data with encrypted storage in the cloud.

    Isla interfaces with Electronic Health Record (EHR) systems including Cerner, enabling health professionals to view data held on Isla's servers from within the electronic patient record, via the 'Cerner Red Button'. Health professionals can also view a patient's visual record through a secure weblink requiring an NHS email address and password.

Study groups in NCT06504641
Study groupRoleWhat they receive
PatientsUp to 30 adults, aged 65 years or older, who are frail or pre-frail, and who are admitted as an inpatient to an acute Medicine for the Elderly ward during a three-month pilot phase Intervention: Isla for Frailty - video-based patient records. Isla is a technology company providing a visual patient record platform. The platform allows anyone involved in a patient's care to capture and review visual data (photographs, videos) relating to a patient's health. The platform is web-based (a "progressive web application") and supports secure capture of visual data with encrypted storage in the cloud. Isla interfaces with Electronic Health Record (EHR) systems including Cerner, enabling health professionals to view data held on Isla's servers from within the electronic patient record, via the 'Cerner Red Button'. Health professionals can also view a patient's visual record through a secure weblink requiring an NHS email address and password.
Receives: Other: Isla for Frailty
CarersCarers of enrolled patients, who are in receipt of the Isla for Frailty intervention (described above) Carers are those who provide the enrolled patient with assistance in their daily activities and are unpaid for these caring activities. A carer may be a member of the patient's family, a friend, or other person who provides the patient with unpaid care.
Receives: Other: Isla for Frailty
Ward teamClinical staff working on one of three Medicine for the Elderly wards at St Mary's Hospital, where the Isla for Frailty intervention (described above) will be subject to a feasibility trial. Clinical staff must work regular shifts on the ward during study initiation and pilot phases.
Receives: Other: Isla for Frailty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intervention acceptability [1]

    Patient and carer perspectives on the acceptability of video-based records will be assessed within this mixed-methods feasibility study and process evaluation multiple measures:

    [a] Proportion of eligible participants declining enrolment and reasons for non-participation (% declining, descriptive statistics)

    Measured: Within three-month pilot phase

  2. Intervention acceptability [2]

    Patient perspectives on the acceptability of video-based records will be assessed within this mixed-methods feasibility study and process evaluation multiple measures:

    [b] Proportion of enrolled patients with ≥ 1 video linked to the electronic patient record (% with at least one video linked to electronic patient record, descriptive statistics)

    Measured: Within three-month pilot phase

  3. Intervention acceptability [3]

    Patient and carer perspectives on the acceptability of video-based records will be assessed within this mixed-methods feasibility study and process evaluation multiple measures:

    [c] Semi-structured interview at or within 2 weeks of discharge (Framework analysis to understand patient and carer views on acceptability)

    Measured: At or within two weeks of patient discharge

  4. Intervention acceptability [4]

    Ward team perspectives on the acceptability of video-based records will be assessed within this mixed-methods feasibility study and process evaluation multiple measures:

    [a] Video evaluation questionnaire (a combination of stuctured and open-ended questions asking ward team to appraise whether video quality is suitable for clinical interpretation: Yes/No/To some extent; Video length: Too long/Too short/Just right, Whether ward team want to see more patient videos in the future: Yes/No - descriptive statistics. Open-ended questions ask ward team to explain their answers)

    Measured: Within three-month pilot phase

  5. Intervention acceptability [5]

    Ward team perspectives on the acceptability of video-based records will be assessed within this mixed-methods feasibility study and process evaluation multiple measures:

    [b] Semi-structured interview after the three-month pilot (Framework analysis to understand ward team views on acceptability)

    Measured: Ward staff interviews to be conducted within two months after three-month pilot phase

  6. Intervention acceptability [6]

    Ward team perspectives on the acceptability of video-based records will be assessed within this mixed-methods feasibility study and process evaluation multiple measures:

    [c] Number of videos requested, attempted \& submitted (Quantitative, descriptive statistics)

    Measured: Within three-month pilot phase

Secondary outcomes (10)
  1. Intervention feasibility - Patient enrolment [1]

    The feasibility of implementing a visual medical record platform (Isla) in the acute Medicine for the Elderly setting will be assessed within this mixed-methods feasibility study and process evaluation using multiple measures:

    [a] Proportion of eligible participants who were enrolled into the study (% enrolling, descriptive statistics)

    Measured: Within three-month pilot phase

  2. Intervention feasibility - Patient enrolment [2]

    The feasibility of implementing a visual medical record platform (Isla) in the acute Medicine for the Elderly setting will be assessed within this mixed-methods feasibility study and process evaluation using multiple measures:

    [b] Diversity of patient sample (Descriptive statistics to summarise sex; age; ethnicity; language spoken at home; Clinical Frailty Score [1-9]; dementia diagnosis [yes/no]; capacity to consent to study participation [yes/no] of patients who were enrolled, versus patients who declined participation)

    Measured: Within three-month pilot phase

  3. Intervention feasibility - Intervention barriers and facilitators [1]

    The feasibility of implementing a visual medical record platform (Isla) in the acute Medicine for the Elderly setting will be assessed within this mixed-methods feasibility study and process evaluation using multiple measures:

    [a] Semi-structured interviews with patients/carers (Framework analysis to understand patient and carer views on intervention barriers and facilitators)

    Measured: At or within two weeks of patient discharge

  4. Intervention feasibility - Intervention barriers and facilitators [2]

    The feasibility of implementing a visual medical record platform (Isla) in the acute Medicine for the Elderly setting will be assessed within this mixed-methods feasibility study and process evaluation using multiple measures:

    [b] Semi-structured interviews with direct care team (Framework analysis to understand ward team views on intervention barriers and facilitators)

    Measured: Ward staff interviews to be conducted within two months after three-month pilot phase

  5. Intervention feasibility - Use of the Isla platform [1]

    The feasibility of implementing a visual medical record platform (Isla) in the acute Medicine for the Elderly setting will be assessed within this mixed-methods feasibility study and process evaluation using multiple measures:

    [a] Proportion of enrolled patients with videos linked to the electronic patient record (% of patients with videos linked to electronic patient record, descriptive statistics)

    Measured: Within three-month pilot phase

  6. Intervention feasibility - Use of the Isla platform [2]

    The feasibility of implementing a visual medical record platform (Isla) in the acute Medicine for the Elderly setting will be assessed within this mixed-methods feasibility study and process evaluation using multiple measures:

    [b] Video view metrics (number of video views, descriptive statistics)

    Measured: Within three-month pilot phase

  7. Intervention feasibility - Privacy and security concerns [1]

    The feasibility of implementing a visual medical record platform (Isla) in the acute Medicine for the Elderly setting will be assessed within this mixed-methods feasibility study and process evaluation using multiple measures:

    [a] Number of videos raising cause for concern reported to the clinical lead (number of videos reported to clinical lead, descriptive statistics)

    Measured: Within three-month pilot phase

  8. Perceived effectiveness of intervention [1]

    The perceived effectiveness of patient videos for supporting elderly inpatient care (e.g. perceived impacts on inpatient assessment \& clinical decision-making, multi-disciplinary team communication, care continuity during a hospital stay, person-centred care during a hospital stay) will be assessed within this mixed-methods feasibility study and process evaluation using multiple measures:

    [a] Video evaluation questionnaires (a combination of stuctured and open-ended questions asking ward team to appraise video usefulness for supporting patient assessment: Very useful/Somewhat useful/Useless; Usefulness of video for supporting decision-making: Very useful/Somewhat useful/Useless; Usefulness of video for communicating patient information to colleagues: Very useful/Somewhat useful/Useless - descriptive statistics. Open-ended questions ask ward team to explain their answers)

    Measured: Within three-month pilot phase

  9. Perceived effectiveness of intervention [2]

    The perceived effectiveness of patient videos for supporting elderly inpatient care (e.g. perceived impacts on inpatient assessment \& clinical decision-making, multi-disciplinary team communication, care continuity during a hospital stay, person-centred care during a hospital stay) will be assessed within this mixed-methods feasibility study and process evaluation using multiple measures:

    [b] Semi-structured interviews with direct care team after the pilot (Framework analysis to understand ward team views on perceived effectiveness)

    Measured: Ward staff interviews to be conducted within two months after three-month pilot phase

  10. Perceived effectiveness of [3]

    The perceived effectiveness of patient videos for supporting elderly inpatient care (e.g. perceived impacts on inpatient assessment \& clinical decision-making, multi-disciplinary team communication, care continuity during a hospital stay, person-centred care during a hospital stay) will be assessed within this mixed-methods feasibility study and process evaluation using multiple measures:

    [c] Semi-structured interviews with patients/patient-carer dyads at or within 2 weeks of discharge (Framework analysis to understand patient and carer views on perceived effectiveness)

    Measured: At or within two weeks of patient discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2024
  2. Study start14 Feb 2024
  3. Primary completion31 Jul 2024 (estimated)
  4. Study completion30 Sep 2024 (estimated)

Resources

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
Case only
Time perspective
Prospective
Enrolment
95 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06504641
Sponsor's protocol ID
23SM8192
Acronym
I4F
Status last verified
Jul 2024
First submitted
10 Jul 2024
Last updated
18 Jul 2024
Results posted
No
FDA-regulated drug
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Frailty, run by Imperial College London 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 11 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Jul 2024. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Phoebe Averill, PhD (020 7594 9038, phoebe.averill@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intervention acceptability [1] (time frame: Within three-month pilot phase). The study lists 6 primary outcomes in all. 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 18 Jul 2024.

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