I4F: Isla for Frailty Feasibility Study
NCT Number: NCT06504641
Acronym: I4F
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Frailty
Interventions: OTHER: Isla for Frailty
Sponsor: Imperial College London
Collaborators: Imperial College Healthcare NHS Trust|National Institute for Health Research, United Kingdom|Health Education England
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 95
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-14
Completion Date: 2024-09-30
Locations: St Mary's Hospital, London, W2 1NY, United Kingdom

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. 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.

Primary Outcome Measures: 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), Within three-month pilot phase|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), Within three-month pilot phase|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), At or within two weeks of patient discharge|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), Within three-month pilot phase|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), Ward staff interviews to be conducted within two months after three-month pilot phase|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), Within three-month pilot phase
Secondary Outcome Measures: 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), Within three-month pilot phase|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), Within three-month pilot phase|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), At or within two weeks of patient discharge|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), Ward staff interviews to be conducted within two months after three-month pilot phase|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), Within three-month pilot phase|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), Within three-month pilot phase|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), Within three-month pilot phase|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), Within three-month pilot phase|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), Ward staff interviews to be conducted within two months after three-month pilot phase|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), At or within two weeks of patient discharge