A frailty care bundle to improve mobilisation (walking), nutrition and distraction activities for older people during an acute hospital stay
| ISRCTN | ISRCTN15145850 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15145850 |
- Submission date
- 26/09/2022
- Registration date
- 03/10/2022
- Last edited
- 04/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Older people admitted to acute care hospitals are more likely to experience a decline in physical function (ability to walk) due to inactivity (sitting in a bed or chair) and or sup-optimal food and fluid intake - this is termed hospital-associated decline. The patient may also experience brain fuzziness and poor concentration due to a lack of cognitive (mind) stimulation and orientation. Patients who experience trauma such as a hip fracture are at very high risk of decline. The study aimed to reduce the risk of a decline in physical and cognitive function by increasing patients' opportunity to walk more, eat food rich in protein and engage in distraction activities to stimulate the mind.
Who can participate?
The study will be undertaken in four acute trauma and rehabilitation wards and four medical wards. All patients aged 65 years old and over in the participating acute trauma wards will be eligible to receive the intervention. A subset of patients who could provide written consent will be recruited for the evaluation. All nursing staff working in the participating wards will be included in the study.
What does the study involve?
The evaluation used a pre (baseline)- post-intervention design. The main outcome of interest was the patient's physical function.
Nursing staff received education on strategies to prioritise patient mobilisation, nutrition and cognitive engagement above competing demands on nursing times. This included a) setting an individual patient mobility (walking) goal, assisting patients during meal times, providing extra snacks for patients, providing distraction resources, providing a patient information leaflet, audit and feedback on patient mobilisation and nutrition intake.
What are the possible benefits and risks of participating?
There is more nursing attention on fundamental care including encouraging and assisting patients to walk and eat. Patients have access to distraction resources (colouring books, puzzles, and crosswords). Participants will be more likely to maintain or regain their physical function and are better able to maintain independence once they return home. There was minimal additional risk above routine hospital care associated with participating in the study intervention for patients or staff. The study aimed to improve evidence-based standards in care on mobilisation, nutrition and cognitive engagement for older people. While staff participation in the intervention (education, use of goal setting, and supporting patient cognition) was encouraged as part of normalized principles of good fundamental care, staff ultimately could decide not to engage. There was a risk of research-associated fatigue in answering questions or completing surveys. Participation in all evaluation activities was voluntary. Staff and patients could withdraw at any time without providing a reason.
Where is the study run from?
The School of Nursing and Midwifery University College Cork (Ireland)
When is the study starting and how long is it expected to run for?
January 2019 to July 2022 (the trial was extended by 1 year due to COVID-19 pandemic disruption)
Who is funding the study?
Health Research Board (HRB) (Ireland)
Who is the main contact?
Professor Corina Naughton
corina.naughton@ucc.ie
Contact information
Principal Investigator
School of Nursing and Midwifery
College of Medicine and Health
Brookfield Health Sciences Complex
Cork
T12 AK54
Ireland
 ORCID ID |
0000-0001-8360-064X |
|---|---|
| Phone | +353 214901551 |
| corina.naughton@ucc.ie |
Study information
| Study design | Multicentre interventional pre-post study design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | 42504 Patient Information v1.3 12oct2019.pdf |
| Scientific title | Implementation of the Frailty Care Bundle (FCB) to promote mobilisation, nutrition and cognitive engagement in older people in acute care settings |
| Study acronym | FCB |
| Study objectives | Implementation of the Frailty Care Bundle will reduce the risk of functional decline by increasing older patients' mobilisation, nutrition intake and cognitive engagement in acute care settings |
| Ethics approval(s) | Approved 12/11/2019, Clinical Research Ethics Committee of the Cork Teaching Hospitals (University College Cork, Lancaster Hall, 6 Little Hanover Street, Cork, Ireland; +353-21-4901901; crec@ucc.ie), ref: ECM3 12/11/2019 |
| Health condition(s) or problem(s) studied | Prevention of functional decline in older patients during hospitalisation |
| Intervention | The Frailty Care Bundle (FCB) is a multi-component behaviour change intervention aimed at nursing and the wider multidisciplinary team. All hospital wards in the study received the intervention, there were no control wards. The intervention involved a clinical facilitator working with ward staff to deliver staff education, set patient mobility goals, introduce a patient mobility board to aid nursing and physiotherapy communication on mobility, promote assisted mealtimes, provide extra snacks, and provide distraction resources. All patients on the ward were eligible to receive the intervention delivered by ward staff, and a subset of patients who provided informed written consent were recruited for the evaluation. |
| Intervention type | Behavioural |
| Primary outcome measure | Patient physical function measured using the modified Bartel Index at baseline (pre-hospital admission), enrollment to study, hospital discharge and 6-8 weeks following hospital discharge |
| Secondary outcome measures | 1. Patients’ average daily step count was measured using an accelerometer The Step Watch Activity Monitor (SAM), over 3-4 days on enrollment and into the study during hospitalisation 2. Gait speed-measured using a 4-metre walking test at enrollment to study and hospital discharge 2. Hand-grip strength measured using Jamar Dynamometer at enrollment to study and hospital discharge 3. Appetite measured using the simple nutrition assessment questionnaire (SNAQ) at enrollment to study, hospital discharge and 6-8 weeks follow-up 4. Quality of life measured using EQ-5D Visual Analogue Scale (EuroQol Group 2009) at enrollment to study and 6-8 weeks follow-up Staff outcome measures in a pre-post staff survey 5. Attitude to mobilisation measured using Barriers to Mobilisation (Hoyer et al 2015) 6. Attitudes to nutrition measured using a bespoke instrument pre-post intervention 7. Intervention acceptability, perceived improvement in mobilisation, nutrition, and cognitive activity measured using a bespoke instrument post-intervention staff survey |
| Overall study start date | 25/01/2019 |
| Completion date | 31/07/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 60 Years |
| Sex | Both |
| Target number of participants | 180 |
| Total final enrolment | 120 |
| Key inclusion criteria | 1. Aged 65 years old and over (age limit was reduced to 60 years to increase the pool of patients for recruitment) 2. Medically stable and able to sit out of bed 3. Eligible to be mobilised by nursing staff based on physiotherapy or nursing assessment 4. Mobile prior to admission (able to walk across a medium-size room (e.g. 3-4 meters, +/-walking aid) in the two weeks prior to admission 5. Able to provide written informed consent (no significant cognitive impairment or delirium as measured by 4-AT or recorded in medical notes) |
| Key exclusion criteria | 1. Unable to mobilise with assistance prior to admission 2. Can only be mobilised by a physiotherapist 3. Patients on end-of-life or palliative pathway 4. Patients who cannot provide informed consent to participate |
| Date of first enrolment | 20/11/2019 |
| Date of final enrolment | 30/01/2022 |
Locations
Countries of recruitment
- Ireland
Study participating centres
Cork
T12 EC8P
Ireland
Cork
T12 V0HD
Ireland
Mallow
Co Cork
P51 N288
Ireland
Sponsor information
Government
Grattan House
67-72 Lower Mount Street
Dublin
D02 H638
Ireland
| Phone | +353 1 2345000 |
|---|---|
| gemshelp@hrb.ie | |
| Website | http://www.hrb.ie/ |
"ROR" |
https://ror.org/003hb2249 |
Hospital/treatment centre
Erinville
Western Road
Cork
T12 EDKO
Ireland
| Phone | +353 21 4921509 |
|---|---|
| ceo.sswhg@hse.ie | |
| Website | https://www.hse.ie/eng/about/who/acute-hospitals-division/hospital-groups/south-southwest/ |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Health Research Board, Ireland, An Bord Taighde Sláinte, HRB
- Location
- Ireland
Results and Publications
| Intention to publish date | 01/09/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 11/01/2022 | 27/09/2022 | Yes | No | |
| Participant information sheet | version 1.3 | 12/10/2019 | 03/10/2022 | No | Yes |
| Participant information sheet | version 1.3 | 12/10/2019 | 03/10/2022 | No | Yes |
| Results article | 01/03/2024 | 11/03/2024 | Yes | No | |
| Other publications | Economic cost analysis | 01/09/2024 | 04/09/2024 | Yes | No |
Additional files
Editorial Notes
04/09/2024: Publication reference added.
11/03/2024: Publication reference added.
03/10/2022: Trial's existence confirmed by the Clinical Research Ethics Committee of the Cork Teaching Hospitals.
