Help Optimise and Mobilise Elders (H.O.M.E)

Mobility Limitation Clinical Trial

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Official title:

Help Optimise and Mobilise Elders (H.O.M.E)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05484063
• Other study ID #: GERI1627
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 25, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: June 2022
• Source: JurongHealth
• Contact: Melanie Tan Dr
• Phone: 67165237
• Email: melanie_tan[@]nuhs.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: September 30, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Functional Disturbance
• Mobility Limitation

Intervention

Other:
• Multicomponent, mobility-focused intervention
The intervention group will receive early therapist review (within one working day of admission to HOME unit), to be mobilised at least three times a day. They will also receive additional group exercise therapy sessions, as well as nurse screening for geriatric syndromes. Besides that, they will be screened for 4Ms (Mobility, Mentation, Medication, What Matters) by doctor on admission.

Locations

Country	Name	City	State
Singapore	Geriatrics Education and Research Institute	Singapore
Singapore	Ng Teng Fong Hospital	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
JurongHealth	Geriatric Education and Research Institute, National Healthcare Group, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (25)

Boyd CM, Landefeld CS, Counsell SR, Palmer RM, Fortinsky RH, Kresevic D, Burant C, Covinsky KE. Recovery of activities of daily living in older adults after hospitalization for acute medical illness. J Am Geriatr Soc. 2008 Dec;56(12):2171-9. doi: 10.1111/j.1532-5415.2008.02023.x. — View Citation

Chan EY, Samsudin SA, Lim YJ. Older patients' perception of engagement in functional self-care during hospitalization: A qualitative study. Geriatr Nurs. 2020 May - Jun;41(3):297-304. doi: 10.1016/j.gerinurse.2019.11.009. Epub 2019 Nov 29. — View Citation

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Hastings SN, Choate AL, Mahanna EP, Floegel TA, Allen KD, Van Houtven CH, Wang V. Early Mobility in the Hospital: Lessons Learned from the STRIDE Program. Geriatrics (Basel). 2018 Dec;3(4). pii: 61. doi: 10.3390/geriatrics3040061. Epub 2018 Sep 26. — View Citation

Hastings SN, Sloane R, Morey MC, Pavon JM, Hoenig H. Assisted early mobility for hospitalized older veterans: preliminary data from the STRIDE program. J Am Geriatr Soc. 2014 Nov;62(11):2180-4. doi: 10.1111/jgs.13095. Epub 2014 Oct 30. — View Citation

Hirsch CH, Sommers L, Olsen A, Mullen L, Winograd CH. The natural history of functional morbidity in hospitalized older patients. J Am Geriatr Soc. 1990 Dec;38(12):1296-303. Review. — View Citation

Hoyer EH, Friedman M, Lavezza A, Wagner-Kosmakos K, Lewis-Cherry R, Skolnik JL, Byers SP, Atanelov L, Colantuoni E, Brotman DJ, Needham DM. Promoting mobility and reducing length of stay in hospitalized general medicine patients: A quality-improvement project. J Hosp Med. 2016 May;11(5):341-7. doi: 10.1002/jhm.2546. Epub 2016 Feb 5. — View Citation

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Kongkasuwan R, Voraakhom K, Pisolayabutra P, Maneechai P, Boonin J, Kuptniratsaikul V. Creative art therapy to enhance rehabilitation for stroke patients: a randomized controlled trial. Clin Rehabil. 2016 Oct;30(10):1016-1023. Epub 2015 Sep 22. — View Citation

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Lim SH, Ang SY, Ong HK, Lee TZY, Lee TXL, Luo EZ, Thilarajah S. Promotion of mobility among hospitalised older adults: An exploratory study on perceptions of patients, carers and nurses. Geriatr Nurs. 2020 Sep - Oct;41(5):608-614. doi: 10.1016/j.gerinurse.2020.03.015. Epub 2020 Apr 5. — View Citation

Liu B, Moore JE, Almaawiy U, Chan WH, Khan S, Ewusie J, Hamid JS, Straus SE; MOVE ON Collaboration. Outcomes of Mobilisation of Vulnerable Elders in Ontario (MOVE ON): a multisite interrupted time series evaluation of an implementation intervention to increase patient mobilisation. Age Ageing. 2018 Jan 1;47(1):112-119. doi: 10.1093/ageing/afx128. — View Citation

Loyd C, Markland AD, Zhang Y, Fowler M, Harper S, Wright NC, Carter CS, Buford TW, Smith CH, Kennedy R, Brown CJ. Prevalence of Hospital-Associated Disability in Older Adults: A Meta-analysis. J Am Med Dir Assoc. 2020 Apr;21(4):455-461.e5. doi: 10.1016/j.jamda.2019.09.015. Epub 2019 Nov 14. Review. — View Citation

Mate KS, Berman A, Laderman M, Kabcenell A, Fulmer T. Creating Age-Friendly Health Systems - A vision for better care of older adults. Healthc (Amst). 2018 Mar;6(1):4-6. doi: 10.1016/j.hjdsi.2017.05.005. Epub 2017 Aug 1. — View Citation

Murray ME, Wells TJ, Callen BL. Hospital resource utilization and functional decline of geriatric patients. Nurs Econ. 2003 May-Jun;21(3):114-9. — View Citation

Olson EV, Johnson BJ, Thompson LF. The hazards of immobility. 1967. Am J Nurs. 1990 Mar;90(3):43-8. — View Citation

Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7. — View Citation

Raymond MJ, Jeffs KJ, Winter A, Soh SE, Hunter P, Holland AE. The effects of a high-intensity functional exercise group on clinical outcomes in hospitalised older adults: an assessor-blinded, randomised-controlled trial. Age Ageing. 2017 Mar 1;46(2):208-213. doi: 10.1093/ageing/afw215. — View Citation

Renner CIe, Outermans J, Ludwig R, Brendel C, Kwakkel G, Hummelsheim H. Group therapy task training versus individual task training during inpatient stroke rehabilitation: a randomised controlled trial. Clin Rehabil. 2016 Jul;30(7):637-48. doi: 10.1177/0269215515600206. Epub 2015 Aug 27. — View Citation

Smart DA, Dermody G, Coronado ME, Wilson M. Mobility Programs for the Hospitalized Older Adult: A Scoping Review. Gerontol Geriatr Med. 2018 Nov 1;4:2333721418808146. doi: 10.1177/2333721418808146. eCollection 2018 Jan-Dec. Review. — View Citation

Smith TO, Sreekanta A, Walkeden S, Penhale B, Hanson S. Interventions for reducing hospital-associated deconditioning: A systematic review and meta-analysis. Arch Gerontol Geriatr. 2020 Sep - Oct;90:104176. doi: 10.1016/j.archger.2020.104176. Epub 2020 Jul 6. Review. — View Citation

Surkan MJ, Gibson W. Interventions to Mobilize Elderly Patients and Reduce Length of Hospital Stay. Can J Cardiol. 2018 Jul;34(7):881-888. doi: 10.1016/j.cjca.2018.04.033. Epub 2018 May 9. Review. — View Citation

Wallin M, Talvitie U, Cattan M, Karppi SL. Construction of group exercise sessions in geriatric inpatient rehabilitation. Health Commun. 2008;23(3):245-52. doi: 10.1080/10410230802055349. — View Citation

Wu HY, Sahadevan S, Ding YY. Factors associated with functional decline of hospitalised older persons following discharge from an acute geriatric unit. Ann Acad Med Singap. 2006 Jan;35(1):17-23. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality	1 denotes survival while 0 denotes the participant passed away	1-month follow-up post-discharge
Other	Readmission	The number of readmission due to the index admission within 30 days post discharged	1-month follow-up post-discharge
Other	Healthcare utilisation data and associated costs	Number of visits (associated with index admission) to emergency department, specialist outpatient clinic, general practitioner and the associated costs within 30 days post-discharged	1-month follow-up post-discharge
Other	Ambulatory status	Self-reported by the participant. Four options: 0 denotes bed-bound, 1 denotes chair-bound, 2 denotes assisted (furniture cruiser, walking frame, rollator frame, quadstick, single point stick); 4 denotes independent	1-month follow-up post-discharge
Other	Fall	0 denotes no fall; 1 denotes fall(s) occured (within 30days post-discharged)	1-month follow-up post-discharge
Other	Utilisation of community resources	Self-reported by the participant: Five options: 0 denotes home care; 1 denotes day care; 2 denotes meals on wheels; 3 denotes medical escort service; 4 denotes home personal care	1-month follow-up post-discharge
Primary	Change in maximum distance walked	The total distance covered by the research participant (in meter)	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)
Primary	Mobilisation frequency	Number of times mobilised. The average mobilisation frequency will be calculated by dividing the sum by the number of admission days.	Through the duration of admission
Secondary	Change in modified barthel score	The score ranges from 0 to 100 with 0 as the worst outcome	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
Secondary	Change in gait speed	4 meter gait speed test (meter/second)	Upon admission and at discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
Secondary	Inpatient length of stay and discharge location	The duration of admission (days) and the location the respective participant is discharged to	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)
Secondary	Presence of common iatrogenic complications such as delirium, injurious falls, pressure ulcers, and venous thromboembolisms	Each of the complication will be measured in nominal scale; 0 denotes the absence of the complication while 1 denotes the presence of the complications. The total number of complications arise will be calculated. The greater the number indicates poorer outcome	At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
Secondary	Gross amount of patient's bill during index admission, considering subsidy level	The total gross amount of participant's bill during index admission. The subsidy level will be documented	At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
Secondary	The intervention related costs for group therapy	The number of group therapy sessions attended by the participant multiply by the cost for one group therapy session. The subsidy level will be documented.	At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)