Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000028505
Ethics application status
Approved
Date submitted
8/12/2023
Date registered
12/01/2024
Date last updated
1/06/2024
Date data sharing statement initially provided
12/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Enhancing allied health for older people in residential care: EAHOP RC
Scientific title
Enhancing Allied Health for Older People in Residential Care: The EAHOP (RC) trial. A protocol for a non-randomised, stepped waitlist trial on frailty and number of falls.
Secondary ID [1] 308768 0
Nil known
Universal Trial Number (UTN)
U1111-1287-1021
Trial acronym
EAHOP (RC)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dementia 328715 0
frailty 331703 0
falls 331704 0
Condition category
Condition code
Neurological 325725 325725 0 0
Dementias
Physical Medicine / Rehabilitation 328439 328439 0 0
Occupational therapy
Physical Medicine / Rehabilitation 328440 328440 0 0
Physiotherapy
Physical Medicine / Rehabilitation 328441 328441 0 0
Speech therapy
Physical Medicine / Rehabilitation 328442 328442 0 0
Other physical medicine / rehabilitation
Diet and Nutrition 328443 328443 0 0
Other diet and nutrition disorders
Eye 328646 328646 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Model of Care
The trial will use the Institute for Healthcare Improvement 4Ms framework of an age-friendly health system as the model of care to organise allied health interventions. The 4Ms are:
• What Matters: Know and align care with each older adult’s goals and care preferences.
• Mentation: Prevent, identify, treat and manage dementia, depression and delirium across care settings.
• Medication: If medication is necessary, it should not interfere with What Matters to the older person.
• Mobility: Ensure that older people move safely every day.

Case conferencing
Following consent into the study each participant and their family member/carer will have the option of undertaking a case conference where the General Practitioner, the clinical liaison manager and all allied health professionals will discuss the need for one or more allied health interventions. The participant will be screened prior to the case conference to inform the decision making. The participant will then be referred to the relevant allied health professional to commence the intervention. The nature and timing of the interventions across disciplines will vary according to the needs of individual participants. Each participant is expected to be discussed for 20 minutes during the case conference with up to 5 participants being discussed each case conference.

Clinical Liaison Manager
A clinical liaison manager will be embedded within the aged care home with the overall goal of ensuring the case conferences and interventions are implemented as intended and providing a communication link between the aged care team the embedded allied health team and the research team. The Clinical Liaison Manager will be responsible for participant recruitment and consent processes as well as outcome measures data collection in consultation with the allied health professionals and allied health assistants, and the implementation of the Action Falls program within the residential aged care site.

Allied Health Professionals and General Practitioner
There are six allied health professionals: dietitian, pharmacist, physiotherapist, occupational therapist, optometrist and speech pathologist who will provide discipline specific interventions as identified in the case conference with a general practitioner assisting with coordination of care.

Allied Health Assistants
Allied health assistants will work directly with four of the allied health professionals (dietitian, occupational therapist, physiotherapist and speech pathologist) to implement the prescribed allied health interventions.

Intervention
This is a stepped design where six groups of 10 participants will start the intervention every three weeks from the start of the previous group. Participants will be allocated to groups based upon when they enrol in the study. Every participant will complete the primary outcome measures. The secondary outcome measure relating to pain will be completed by every participant. The other secondary outcome measures will be completed by participants as relevant to their allied health needs. The exceptions to this will be all participants will complete the Subjective Global Assessment (Dietetics) and the Holden Communication Scale (Speech pathology) but only participants assessed as mild to moderately malnourished (B), or severely malnourished (C) or with communication challenges will be referred to the dietetics or speech pathology interventions respectively. The intervention period for all participants is 36 weeks.

Occupational Therapy: Participants will identify tasks and activities of everyday living with specific reference to self-care, leisure activities and productivity that are meaningful to them that they would like to be engaged with and/or become more satisfied with. The occupational therapist will develop individualised occupational therapy interventions to improve performance and satisfaction with identified occupational performance challenges. The duration and frequency of occupational therapy will vary depending on the participant's goals however an estimate is three times per week for 1 hour.

Physiotherapy: Participants will engage in the SUNBEAM program ( Hewitt et al., 2018) involving 2 hours per week of individually tailored strength and balance exercises prescribed by the physiotherapist for 25 weeks (total 50 hours) and then a maintenance program for the duration of the trial. Strength training includes resistance training with varying levels of resistance bands. Balance training involves activities that vary the base of support. In some instances, participants may not be suitable for the SUNBEAM program. In these cases, they will be offered a virtual cycling experience (D'Cunha et al., 2021) once a week for the duration of the trial.

Dietetics and Nutrition: Participants diagnosed as mild to moderately malnourished (B), or severely malnourished (C) (using the Subjective Global Assessment) will be provided: a high protein, high energy diet by fortifying menu items such as porridge, soups, mashed potato, and desserts; and/ or oral nutrition supplements. In addition, the dietitian will provide modified menus to Food Service Staff and training to Food Service staff on how to fortify menu items as per modified menus. The duration and frequency of dietetic intervention will vary depending on the participant's goals however an estimate is three times per week for 1 hour.

Speech Pathology: Participants will receive interventions focused on communication partner training over the period of the trial. The speech pathology intervention will include communication repair strategies, an education component, role play, practice and recording of communication interactions to identify and address communication challenges. If the following: swallowing related difficulties, coughing during or after swallowing, excessive drooling, having a weak or soft voice, aspirating, difficulty chewing, trouble moving food to the back of the mouth or food sticking in throat are observed in a participant a registered nurse within the residential aged care home will be notified. We will provide the registered nurse with a letter to the GP, requesting a referral to the speech pathology provider associated with the organisation. The duration and frequency of speech pathology will vary depending on the participant's goals however an estimate is three times per week for 1 hour.

Optometry: Participants will receive an assessment by an optometrist evaluating visual function (including refraction and visual acuity, macula and lenticular opacities and intra-ocular pressure) to address visual impairments that may contribute to falls risk. Actions arising from assessment of visual function may include new spectacle prescriptions or referral of participants for management of ocular disease. Participants will see an optometrist 2-3 times in total for 45 minutes each session.

Pharmacy: Participants will receive an onsite medication review by a pharmacist who will provide recommendations regarding medication changes to the participant’s GP. After the initial medication review participants will receive an initial 2-week follow-up visit to ensure that medication decisions are implemented in the medication treatment and charts. Each participant will then have a follow-up visit from the pharmacist every 3 months (online or in person).

Action Falls program: In addition to the allied health interventions for individual participants (described above), the trial will also involve an organisational intervention through implementation of the Action Falls program (Logan et al., 2021). An Action Falls checklist will be completed with each participant (and or carer/family member, as appropriate). The Clinical Liaison Manager will oversee the completion of the checklist, which can be done by any member of the trial team or residential aged care staff once training is complete. Completing the checklist will take 30 minutes per resident.
Intervention code [1] 325219 0
Rehabilitation
Intervention code [2] 325220 0
Prevention
Intervention code [3] 327157 0
Lifestyle
Comparator / control treatment
This is a stepped design where six groups of 10 participants will start the intervention at different times. Each group will have a period prior to the intervention starting where they will receive usual care.
Usual care in relation to in house allied health is 1-2 hours per week of physiotherapy.
Control group
Active

Outcomes
Primary outcome [1] 333572 0
Any changes in the number of falls as determined by a review of the resident's medical records.
Timepoint [1] 333572 0
The number of falls in 12 months prior to the start of the intervention. Number of falls during the intervention period. The proportion of residents who fall (falls) and the number of falls for each participant (fall rate). Then at 12 and 24 weeks post intervention period.
Primary outcome [2] 336278 0
Short Form Physical Performance Battery
Timepoint [2] 336278 0
All groups will undertake primary outcomes measures just prior to commencing the intervention and six weeks before the intervention. Then at 12 weeks, 24 weeks and 36 weeks during the intervention. Then at 12 weeks and 24 weeks post intervention.
Primary outcome [3] 336279 0
Quality of Life Aged Care Consumers (QOL-ACC)
Timepoint [3] 336279 0
All groups will undertake primary outcomes measures just prior to commencing the intervention and six weeks before the intervention. Then at 12 weeks, 24 weeks and 36 weeks during the intervention. Then at 12 weeks and 24 weeks post intervention.
Secondary outcome [1] 417569 0
Frail Nursing Home Scale
Timepoint [1] 417569 0
All groups will undertake primary outcomes measures just prior to commencing the intervention and six weeks before the intervention. Then at 12 weeks, 24 weeks and 36 weeks during the intervention. Then at 12 weeks and 24 weeks post intervention.
Secondary outcome [2] 417571 0
Pharmacy: Medication review from reviewing the resident's medical record and measures as the rate of GP agreement with Pharmacist recommendations.
Timepoint [2] 417571 0
At the conclusion of the intervention
Secondary outcome [3] 417572 0
Pharmacy: Number of medications (that contributed to increased risk of fall) ceased/changed at case conferences gained by review of the resident's medical record.
Timepoint [3] 417572 0
At the conclusion of the intervention
Secondary outcome [4] 417574 0
Subjective Global Assessment tool (SGA)
Timepoint [4] 417574 0
Baseline and immediately after dietetic intervention ceases. Participants who are assessed as nourished will not repeat this assessment.
Secondary outcome [5] 417575 0
Mid-arm muscle circumference (MAMC) as measured by a soft, non elastic tape measure.
Timepoint [5] 417575 0
Once every 4 weeks (for participants identified as malnourished) for duration of intervention.
Secondary outcome [6] 417576 0
Canadian Occupational Performance Measure (COPM)
Timepoint [6] 417576 0
Baseline and immediately after occupational therapy intervention ceases.
Secondary outcome [7] 417577 0
The National Eye Institute Visual Functioning Questionnaire – 25 (VFQ-25 +10)
Timepoint [7] 417577 0
Baseline and after the optometry intervention ceases.
Secondary outcome [8] 427648 0
Number of new or updated spectacles recommended. Data on spectacle use will be gathered from the medical record and/or family/carer reports.
Timepoint [8] 427648 0
Immediately after the last group completes the optometry intervention.
Secondary outcome [9] 427649 0
Number of referrals for management of ocular disease as reported in the resident's medical record.
Timepoint [9] 427649 0
Immediately after the last group completes the optometry intervention.
Secondary outcome [10] 427650 0
Revised Index for Social Engagement (RISE)
Timepoint [10] 427650 0
Baseline and immediately after occupational therapy intervention ceases .
Secondary outcome [11] 427651 0
Brief Pain Inventory (short form)
Timepoint [11] 427651 0
All groups will undertake primary outcomes measures just prior to commencing the intervention and six weeks before the intervention. Then at 12 weeks, 24 weeks and 36 weeks during the intervention. Then at 12 weeks and 24 weeks post intervention.
Secondary outcome [12] 427652 0
The Pain Assessment in Advanced Dementia (PAINAD) (This will be used only if administration of Brief Pain Inventory short form is not suitable for the participant).
Timepoint [12] 427652 0
All groups will undertake primary outcomes measures just prior to commencing the intervention and six weeks before the intervention. Then at 12 weeks, 24 weeks and 36 weeks during the intervention. Then at 12 weeks and 24 weeks post intervention.
Secondary outcome [13] 427653 0
Each resident will have a completed action falls checklist. Some data on this checklist will be sourced from the resident's medical records.
Timepoint [13] 427653 0
The number of ACTION falls checklists completed at the cessation of the study .
Secondary outcome [14] 427709 0
Pharmacy: number of case conferences and follow-ups as measured by a review of the resident's medical record.
Timepoint [14] 427709 0
At the conclusion of the pharmacy intervention.
Secondary outcome [15] 427775 0
Holden Communication Scale
Timepoint [15] 427775 0
Baseline and immediately after speech pathology intervention ceases for participants referred to speech pathology intervention. Participants who do not experience communication challenges will not repeat this assessment.
Secondary outcome [16] 428433 0
Post program evaluation surveys designed for participants in this study
Timepoint [16] 428433 0
Following the intervention for all participants in the study.
Secondary outcome [17] 428435 0
Quantitative analysis of dietary intake (only for malnourished participants) as measured by the use of food diaries.
Timepoint [17] 428435 0
1-2 days before fortification and within 5 days after diet fortification.
Secondary outcome [18] 429750 0
Hospital leave days as measured by a review of the participant's medical record.
Timepoint [18] 429750 0
At the conclusion of the intervention.
Secondary outcome [19] 430177 0
Post program evaluation surveys designed for families/carers of residents in this study
Timepoint [19] 430177 0
At the conclusion of the intervention
Secondary outcome [20] 430178 0
Post program evaluation surveys designed for staff involved in the study.
Timepoint [20] 430178 0
At the conclusion of the intervention.
Secondary outcome [21] 430222 0
Post program evaluation surveys designed for participants in this study.
Timepoint [21] 430222 0
At the conclusion of the intervention.
Secondary outcome [22] 430223 0
Semi structured interviews with participants in the study designed to elicit their. thoughts, experiences and opinions of being in the study
Timepoint [22] 430223 0
At the conclusion of the intervention.
Secondary outcome [23] 430224 0
Semi structured interviews with families/carers of participants in the study designed to elicit their thoughts, experiences and opinions of the study.
Timepoint [23] 430224 0
At the conclusion of the intervention.
Secondary outcome [24] 430225 0
Semi structured interviews with the staff involved in the study designed to elicit their. thoughts, experiences and opinions the study
Timepoint [24] 430225 0
At the conclusion of the intervention.

Eligibility
Key inclusion criteria
Any new or existing (permanent) resident of the residential aged care home is eligible.
Any staff member from Calvary Haydon who cares for the participant will be eligible to complete a post intervention staff survey and/or semi-structured interview.
Any family member/carer of a participant will be eligible to complete a post intervention survey and/or semi-structured interview.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People with severe cognitive impairment will not be able to engage in the allied health program. For example, people who have severe expressive and receptive communication impairment and who are immobile due to dementia are unlikely to be able to meaningfully engage in the program.
There are no specific exclusion criteria for family member/carer involvement or staff involvement.

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Quantitative analysis
Baseline demographic and descriptive statistics will be summarised for each group prior to the intervention starting. Primary outcome measures will be collected twice in the pre-intervention period at weeks -6 and week 0. Each group will have primary outcome and pain measures collected at 12 weeks, 24 weeks and 36 weeks. Intervention will cease at 36 weeks for all groups and follow up primary outcome and pain measures will be collected at 12 weeks and 24 weeks. Secondary outcome measures will generally be collected pre and post the relevant allied health intervention as needed. Categorical data will be summarised using frequency statistics and will be visualised. Continuous and other numerical data will be visually explored and summarised using sample descriptive statistics, selected as appropriate based on apparent distributions. R will be used to conduct a multilevel model. For each outcome variable, a generalised linear regression model will be used. Sensitivity analyses will be conducted which will impute missing data using the “mice” package.

Qualitative analysis
We will purposefully sample participants, carers, aged care staff and health professionals as described in the program evaluation. In-depth interviews will be conducted to elicit their thoughts, opinions and experience of the trial. All interviews will be transcribed verbatim, and a reflexive thematic analysis will be completed using a variation of Braun and Clark’s reflexive thematic analysis (Braun & Clark 2019).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/01/2024
Actual
19/02/2024
Date of last participant enrolment
Anticipated
6/05/2025
Actual
Date of last data collection
Anticipated
11/08/2025
Actual
Sample size
Target
60
Accrual to date
18
Final
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 312991 0
Government body
Name [1] 312991 0
Australian Departtment of Health and Aged Care: Medical Research Future Fund
Country [1] 312991 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
University Drive, Bruce, ACT, 2617
Country
Australia
Secondary sponsor category [1] 314674 0
Other Collaborative groups
Name [1] 314674 0
Calvary, Haydon
Address [1] 314674 0
2 Jaegar Cres, Bruce ACT 2617
Country [1] 314674 0
Australia
Secondary sponsor category [2] 314678 0
Commercial sector/Industry
Name [2] 314678 0
Next Practice Health
Address [2] 314678 0
Suite 83, Captain Cook Crescent, Manuka, ACT, 2603
Country [2] 314678 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312254 0
University of Canberra Human Research Committee
Ethics committee address [1] 312254 0
Ethics committee country [1] 312254 0
Australia
Date submitted for ethics approval [1] 312254 0
12/01/2023
Approval date [1] 312254 0
14/04/2023
Ethics approval number [1] 312254 0
12032
Ethics committee name [2] 315436 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [2] 315436 0
Ethics committee country [2] 315436 0
Australia
Date submitted for ethics approval [2] 315436 0
06/02/2024
Approval date [2] 315436 0
19/02/2024
Ethics approval number [2] 315436 0
2024/PID00010

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124006 0
Prof Stephen Isbel
Address 124006 0
University of Canberra Hospital 20 Guraguma St Bruce, ACT, 2617
Country 124006 0
Australia
Phone 124006 0
+61 2 62015246
Fax 124006 0
Email 124006 0
stephen.isbel@canberra.edu.au
Contact person for public queries
Name 124007 0
Stephen Isbel
Address 124007 0
University of Canberra Hospital 20 Guraguma St Bruce, ACT, 2617
Country 124007 0
Australia
Phone 124007 0
+61 2 62015246
Fax 124007 0
Email 124007 0
stephen.isbel@canberra.edu.au
Contact person for scientific queries
Name 124008 0
Stephen Isbel
Address 124008 0
University of Canberra Hospital 20 Guraguma St Bruce, ACT, 2617
Country 124008 0
Australia
Phone 124008 0
+61 2 62015246
Fax 124008 0
Email 124008 0
stephen.isbel@canberra.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.