Clinical trial NCT05484063: Help Optimise and Mobilise Elders (H.O.M.E)
Official title: Help Optimise and Mobilise Elders (H.O.M.E)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mobility Limitation
Functional Disturbance
Keywords: Elderly
Geriatric
Mobility
Inpatient
Functional Decline
Mobility Intervention
Gait speed
Maximum distance walked
Cost impact
length of stay
Multidisciplinary
Implementation study
4Ms (Mobility, Mentation, Medication, What Matters)
Nursing screen
Group therapy
Lead sponsor: JurongHealth
Sponsor class: OTHER_GOV
Collaborators: name: Geriatric Education and Research Institute
name: National Healthcare Group, Singapore
First posted: 2022-08-02
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a quasi-experimental design study.
Primary purpose: PREVENTION

Brief summary: During hospitalisations, older inpatients commonly face issues such as immobility, loss of independence, and functional decline. This leads them down the cascade of dependency with consequent increased risk of adverse outcomes, institutionalisation as well as higher post-acute care costs. The investigators hypothesize that by implementing a mobility intervention in the inpatient setting, patients would be able to maintain their function upon discharge and avoid the cascade of dependency. As such, the investigators aim to do this by implementing and evaluating a mobility intervention, while optimising reversible factors affecting mobility among inpatients admitted to a geriatric unit in Singapore. The investigators will also examine the cost impact of a mobility focused model of care and also adopt the effectiveness-implementation hybrid Type 2 design where both effectiveness and implementation spheres are tested simultaneously.

Detailed description: Aim 1: To examine the effectiveness of multicomponent, mobility-focused model of care in reducing iatrogenic complications and improving patient outcomes. Adopting the Institute for Healthcare Improvement's (IHI) 4Ms framework ("Mobility", "Mentation, "Medication", and "What Matters"), the investigators will examine the effectiveness of timely and individually catered mobility interventions which not only increase mobilization but also optimize factors inhibiting mobility for elderly inpatients. It is hypothesized that the mobility outcomes, such as maximum distance walked and mobilization frequency will be significantly improved for patients who receive the intervention compared to those who receive standard care.

Aim 2: To examine the cost impact of a mobility-focused model of care. The investigators will examine whether the cost of these multicomponent, mobility-focused interventions can be offset from cost savings from early mobilisation benefits, by comparing healthcare utilization costs between-groups. Further to that, a cost effectiveness analysis will be performed should functional effectiveness be observed. For the primary cost impact objective, it is hypothesized that the cost savings arising from reduction in bed days of hospitalization and other medical costs incurred during study period will outweigh the cost of implementing this model of care. In addition, it is also hypothesized that the proposed intervention will be cost-effective through achieving better functional outcomes for patients, with lower costs required.

Aim 3: To evaluate the implementation outcomes of multicomponent, mobility-focused model of care in the process of this intervention. It is hypothesized that this intervention will have good acceptability, feasibility, penetration, implementation costs and sustainability.

Eligibility criteria: Inclusion Criteria:

* Newly admitted patients to the geriatric service
* Aged 75 years and above
* Mobile with or without the use of a walking aid

Exclusion Criteria:

* Vancomycin-resistant enterococcus (VRE) status
* Requires droplet or airborne precautions
* Critically ill
* Haemodynamically instability
* Requires more than 4-hourly parameters
* Systolic blood pressure \<90 mmHg
* Heart rate \>100beats/min
* Non-ambulant patients
* With advanced dementia (Functional Assessment Staging Scale \[FAST\] 7 dementia)
* Fulfills direct admission to another subspecialty unit

Primary outcomes:
measure: Change in maximum distance walked
timeFrame: Upon admission and at the point of discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
measure: Mobilisation frequency
timeFrame: Through the duration of admission
Secondary outcomes:
measure: Change in modified barthel score
timeFrame: Upon admission, at discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay), and one-month post discharge
measure: Change in gait speed
timeFrame: Upon admission and at discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
measure: Inpatient length of stay and discharge location
timeFrame: The duration of admission and upon discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
measure: Presence of common iatrogenic complications such as delirium, injurious falls, pressure ulcers, and venous thromboembolisms
timeFrame: At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
measure: Gross amount of patient's bill during index admission, considering subsidy level
timeFrame: At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
measure: The intervention related costs for group therapy
timeFrame: At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
Other outcomes:
measure: Mortality
timeFrame: 1-month follow-up post-discharge
measure: Readmission
timeFrame: 1-month follow-up post-discharge
measure: Healthcare utilisation data and associated costs
timeFrame: 1-month follow-up post-discharge
measure: Ambulatory status
timeFrame: 1-month follow-up post-discharge
measure: Fall
timeFrame: 1-month follow-up post-discharge
measure: Utilisation of community resources
timeFrame: 1-month follow-up post-discharge
Locations:
city: Singapore
country: Singapore
facility: Ng Teng Fong Hospital
city: Singapore
country: Singapore
facility: Geriatrics Education and Research Institute
Study officials:
affiliation: Ng Teng Fong General Hospital
name: Melanie Tan Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Geriatric Education and Research Institute
name: Lau Lay Khoon Dr
role: PRINCIPAL_INVESTIGATOR
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