Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000205538
Ethics application status
Approved
Date submitted
18/01/2024
Date registered
1/03/2024
Date last updated
1/03/2024
Date data sharing statement initially provided
1/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Post-discharge nutrition care post hip fracture: a feasibility study
Scientific title
Post-discharge nutrition care in older adults with or at risk of malnutrition and frailty post hip fracture: a pre-post feasibility study
Secondary ID [1] 311339 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnourished 332596 0
Frail 332598 0
Hip fracture 332599 0
Condition category
Condition code
Diet and Nutrition 329295 329295 0 0
Other diet and nutrition disorders
Injuries and Accidents 329479 329479 0 0
Fractures
Musculoskeletal 329480 329480 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Once recruited, patients will be enrolled in the study and given an identification (ID) number. They will be sequentially recruited into the control group (pre-implementation phase) and intervention groups (implementation phase). The first 70 patients will be recruited into the control group and the following 70 will be recruited into the intervention group).

Intervention: Patients in the intervention (implementation phase) group will receive usual care which includes:
- Timely surgery
- Orthogeriatric co-care
- Multidisciplinary, multimodal inpatient nutrition care, including:
o Nutrition assessment
o High protein/energy diet choices
o High protein/energy dietary advice
o High protein/energy oral nutrition supplements
o Medical management of nutrition impacting symptoms
o Mealtime assistance and support
o Coordination of care including consideration of post-discharge oral nutrition supplements and/or Meals on Wheels, referral to primary care provider including discharge summary with nutrition status / nutrition care plan documented.

Plus in-kind provision of home delivery of Lite-n-Easy full meal package (3 meals/day for 8 weeks) post hospital discharge, per standard processes defined by Lite-n-Easy:
- Provision of patient-selected breakfast, lunch and dinner meals from the ‘My Choice’ protein- and energy-dense range (details found at https://www.liteneasy.com.au/my-choice)
- Weekly contact from the Lite-n-Easy call centre regarding meal plan choices for the following week and/or any issues regarding products or delivery; and
- To- or in-house delivery as per the individual’s preference.

Participants are permitted to consume meals outside of the provisions from Lite-n-Easy. Food intake will not be supervised, however food intake will be collected at 4-weeks and 8-weeks post discharge, using a 24hr recall methodology. No other strategies will be used to monitor intake or adherence to meals.
Intervention code [1] 327782 0
Lifestyle
Intervention code [2] 327907 0
Treatment: Other
Intervention code [3] 327908 0
Rehabilitation
Comparator / control treatment
Once recruited, patients will be enrolled in the study and given an identification (ID) number. They will be sequentially recruited into the control group (pre-implementation phase) and intervention groups (implementation phase). The first 70 patients will be recruited into the control group and the following 70 will be recruited into the intervention group).

Control: Patients in the control (pre-implementation phase) group will receive usual care, which includes:
- Timely surgery
- Orthogeriatric co-care
- Multidisciplinary, multimodal inpatient nutrition care, including:
o Nutrition assessment
o High protein/energy diet choices
o High protein/energy dietary advice
o High protein/energy oral nutrition supplements
o Medical management of nutrition impacting symptoms
o Mealtime assistance and support
o Coordination of care including consideration of post-discharge oral nutrition supplements and/or Meals on Wheels, referral to primary care provider including discharge summary with nutrition status / nutrition care plan documented.
Control group
Active

Outcomes
Primary outcome [1] 337110 0
Feasibility of intervention (composite primary outcomes)
Timepoint [1] 337110 0
All delivery & adherence outcomes collected at timepoint 2 (4 weeks post hospital discharge), and timepoint 3 (8 weeks post hospital discharge).
All acceptability & implementation / sustainability outcomes collected between timepoint 3 and timepoint 4 (12 months post hospital discharge).
Primary outcome [2] 337111 0
Feasibility of the evaluation design (composite primary outcomes)
Timepoint [2] 337111 0
All recruitment outcomes collected at timepoint 1 (Baseline (within 5 days pre- or post-hospital discharge; in person or via phone)).
All retention outcomes collected at timepoints 1 (Baseline (within 5 days pre- or post-hospital discharge; in person or via phone), 2 (4 weeks post hospital discharge), 3 (8 weeks post hospital discharge), 4 (12 months post hospital discharge).
All data collection outcomes collected at timepoints 1 (Baseline (within 5 days pre- or post-hospital discharge; in person or via phone), 2 (4 weeks post hospital discharge), 3 (8 weeks post hospital discharge), 4 (12 months post hospital discharge).
Secondary outcome [1] 430757 0
Patient-reported quality of life
Timepoint [1] 430757 0
Timepoints 1 (Baseline (within 5 days pre- or post-hospital discharge; in person or via phone), 3 (8 weeks post hospital discharge), and 4 (12 months post hospital discharge).
Secondary outcome [2] 430758 0
Patient Reported Experience Measures, using a questionnaire developed by the research team regarding satisfaction, meal preparation and intake/appetite.
Timepoint [2] 430758 0
Timepoint 3 (8 weeks post hospital discharge)
Secondary outcome [3] 430759 0
BMI and weight
Timepoint [3] 430759 0
Timepoints 1 (Baseline (within 5 days pre- or post-hospital discharge; in person or via phone), 3 (8 weeks post hospital discharge), and 4 (12 months post hospital discharge).
Secondary outcome [4] 430760 0
Physical function
Timepoint [4] 430760 0
Timepoints 1 (Baseline (within 5 days pre- or post-hospital discharge; in person or via phone), 3 (8 weeks post hospital discharge), and 4 (12 months post hospital discharge).
Secondary outcome [5] 430761 0
Nutritional outcomes
Timepoint [5] 430761 0
Timepoints 1 (Baseline (within 5 days pre- or post-hospital discharge; in person or via phone), 3 (8 weeks post hospital discharge), and 4 (12 months post hospital discharge).
Secondary outcome [6] 430762 0
Place of residency at 12months
Timepoint [6] 430762 0
Timepoint 4 (12 months post hospital discharge)
Secondary outcome [7] 430763 0
12-month mortality
Timepoint [7] 430763 0
Timepoint 4 (12 months post hospital discharge)
Secondary outcome [8] 430764 0
Likelihood of cost effectiveness
Timepoint [8] 430764 0
Timepoint 4 (12 months post hospital discharge)
Secondary outcome [9] 431338 0
Public hospital usage (public hospital emergency and inpatient admissions, outpatient utilisation)
Timepoint [9] 431338 0
Timepoint 4 (12 months post hospital discharge)

Eligibility
Key inclusion criteria
(a) =/>65 years; (b) able to provide informed consent (cognitively intact, able to communicate in English); (c) admitted to study site Hip Fracture Unit with hip fracture, proximal femur fracture or peri-prosthetic fracture undergoing surgical intervention and discharged directly home or transferred internally to study site Rehabilitation or GEM Units with aim for home discharge; (d) being discharged to their own home and identified as having to contribute to their own meal preparation following hospital discharge; and (e) remain diagnosed as frail or pre-frail, and malnourished or at risk of malnutrition as assessed using the Mini Nutritional Assessment Short Form within 5 days of discharge
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) critical or terminal illness; (b) metastatic bone disease or pathological fracture; (c) food allergies, no microwave, inadequate freezer space, not consenting to weekly delivery, or not consenting to phone contact provision to vendor to coordinate supply of meals (intervention group only); (d) ASA score 5; (e) living >50km travel distance from study site; or (f) primary treating geriatrician recommended patient not for inclusion

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The study will have a pre-implementation phase where all the participants are allocated to the control group. At the time of completing recruitment to this group (aiming for 70 eligible and consenting participants) the implementation phase will then follow. The implementation phase will allocate all the following participants to the intervention group, (aiming for 70 eligible and consenting participants) at which point recruitment for the study will be completed (aiming for a total of 140 eligible and consenting participants).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: A convenience sample for feasibility testing suggests between 25 and 75 patients per group is likely to be adequate to support feasibility evaluation and sample size calculation for a larger trial. Applying findings from a previous study reporting quality of life in older patients receiving post-discharge meal support, a minimum sample of 64 patients per group is considered appropriate (power 0.8, significance 0.05) to demonstrate a 0.1 (SD 0.2) point difference in quality of life at completion of the pilot RCT. Assuming a 10% drop-out rate, this yields a recommended final pilot RCT sample size of 70 patients per group. As the study site hip fracture service admitted >700 patients with surgical intervention in 2022, with around 240 of those potentially being eligible, a pragmatic approach supports recruitment of 70 patients per group which is expected to be undertaken over a 6–12-month period, dependent on the consent rate. This also aligns with available funding.
Patient and health care worker interviews will be sampled for maximum variation. These will continue until data saturation is reached (or a maximum of 25 patients or 30 health care workers).

Data analysis and statistical considerations: Feasibility outcome data will be reported descriptively (intervention feasibility) and against the pre-determined feasibility criteria (evaluation design feasibility).
Demographic data will be presented descriptively. Continuous data will be presented as mean ±SD (or median and interquartile range for non-normally distributed data). Categorial data will be presented as frequency and percent. Comparisons within and across individuals and groups over time will be made using t-tests or appropriate non-parametric equivalent for continuous data. Chi-squared/exact tests will be used to identify significant differences or associations between categorical variables. Univariable and multivariable logistic regression analyses will be applied to identify the likelihood of patients with improved quality of life, and separately for secondary outcome measures, after adjusting for age, gender, and clinical variables of interest. All data analysis will have input from the research team and reviewed by the study team’s biostatistician.
Qualitative interview data will be thematically analysed using inductive (patient interviews) and deductive (health care worker interviews) methods. A mixed methods approach may be applied to synthesize qualitative and quantitative data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/03/2024
Actual
Date of last participant enrolment
Anticipated
10/02/2025
Actual
Date of last data collection
Anticipated
27/02/2026
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26027 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 41873 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 315593 0
Commercial sector/Industry
Name [1] 315593 0
Lite n Easy
Country [1] 315593 0
Australia
Funding source category [2] 315595 0
Hospital
Name [2] 315595 0
The Prince Charles Hospital
Country [2] 315595 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
170 Kessels Road, Nathan, QLD, 4111
Country
Australia
Secondary sponsor category [1] 317690 0
None
Name [1] 317690 0
Address [1] 317690 0
Country [1] 317690 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314484 0
Metro North Health HREC
Ethics committee address [1] 314484 0
The Prince Charles Hospital, Building 14, Rode Road CHERMSIDE QLD 4032
Ethics committee country [1] 314484 0
Australia
Date submitted for ethics approval [1] 314484 0
02/05/2023
Approval date [1] 314484 0
18/07/2023
Ethics approval number [1] 314484 0
HREC/2023/MNHB/97073
Ethics committee name [2] 314486 0
Griffith University HREC
Ethics committee address [2] 314486 0
170 Kessels Road Nathan QLD 4111
Ethics committee country [2] 314486 0
Australia
Date submitted for ethics approval [2] 314486 0
23/08/2023
Approval date [2] 314486 0
05/09/2023
Ethics approval number [2] 314486 0
2023/704

Summary
Brief summary
Malnutrition is common among hip fracture patients and results in adverse outcomes. The primary aim of this study is to assess the feasibility of intervention delivery and evaluation design in preparation for a larger trial to determine whether providing high energy, high protein meals to older patients following hospitalisation for hip fracture improves patient reported measures and health related outcomes. Primary outcomes relate to feasibility of the intervention and evaluation design. Secondary outcomes include quality of life, patient-reported experience measures, nutritional, functional and health outcomes, and likelihood of cost-effectiveness. This study has potential to improve quality of life and other health outcomes post hospitalisation for hip fracture. If the intervention is shown to be feasible to deliver and evaluate, further research will assess clinical and cost effectiveness.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131750 0
Miss Alita Rushton
Address 131750 0
Griffith University, Gold Coast campus Parklands Drive Southport Qld 4222
Country 131750 0
Australia
Phone 131750 0
+61 07 31396172
Fax 131750 0
Email 131750 0
alita.rushton@griffithuni.edu.au
Contact person for public queries
Name 131751 0
A/Prof Jack Bell
Address 131751 0
The Prince Charles Hospital, Rode Rd, Chermside QLD 4032
Country 131751 0
Australia
Phone 131751 0
+61 07 31396172
Fax 131751 0
Email 131751 0
jack.bell@health.qld.gov.au
Contact person for scientific queries
Name 131752 0
A/Prof Jack Bell
Address 131752 0
The Prince Charles Hospital, Rode Rd, Chermside QLD 4032
Country 131752 0
Australia
Phone 131752 0
+61 07 31396172
Fax 131752 0
Email 131752 0
jack.bell@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to the commercial partnership within this study and ethics processes IPD will not be shared.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.