Help Optimise and Mobilise Elders (H.O.M.E) (HOME)
1 de agosto de 2022 actualizado por: JurongHealth
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
90
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Melanie Tan Dr
- Número de teléfono: 67165237
- Correo electrónico: melanie_tan@nuhs.edu.sg
Ubicaciones de estudio
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Singapore, Singapur, 609606
- Ng Teng Fong Hospital
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Contacto:
- Melanie Tan Dr
- Número de teléfono: 67165237
- Correo electrónico: melanie_tan@nuhs.edu.sg
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Sub-Investigador:
- Seok Mei Lim Dr
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Sub-Investigador:
- Dina Ee Dr
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Sub-Investigador:
- Weng Kin Lai
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Sub-Investigador:
- Russell Yoong
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Sub-Investigador:
- Lydia Au Dr
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Sub-Investigador:
- Bing Kit Chan
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Singapore, Singapur, 768024
- Geriatrics Education and Research Institute
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Contacto:
- Lau Lay Khoon Dr
- Número de teléfono: 68078031
- Correo electrónico: lau.charlene.lk@geri.com.sg
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Sub-Investigador:
- Tou Nien Xiang Dr
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Sub-Investigador:
- Ding Yew Yoong Prof
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Sub-Investigador:
- Michelle Jessica Pereira Dr
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
21 años a 110 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Intervention
Intervention group will receive a multicomponent, mobility-focused intervention during the course of inpatient admission.
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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.
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Sin intervención: Control
The control group will receive usual care as per current ward practice.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in maximum distance walked
Periodo de tiempo: 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)
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The total distance covered by the research participant (in meter)
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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)
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Mobilisation frequency
Periodo de tiempo: Through the duration of admission
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Number of times mobilised.
The average mobilisation frequency will be calculated by dividing the sum by the number of admission days.
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Through the duration of admission
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in modified barthel score
Periodo de tiempo: 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
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The score ranges from 0 to 100 with 0 as the worst outcome
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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
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Change in gait speed
Periodo de tiempo: Upon admission and at discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
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4 meter gait speed test (meter/second)
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Upon admission and at discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
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Inpatient length of stay and discharge location
Periodo de tiempo: 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)
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The duration of admission (days) and the location the respective participant is discharged to
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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)
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Presence of common iatrogenic complications such as delirium, injurious falls, pressure ulcers, and venous thromboembolisms
Periodo de tiempo: At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
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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
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At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
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Gross amount of patient's bill during index admission, considering subsidy level
Periodo de tiempo: At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
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The total gross amount of participant's bill during index admission.
The subsidy level will be documented
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At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
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The intervention related costs for group therapy
Periodo de tiempo: At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
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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.
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At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Mortality
Periodo de tiempo: 1-month follow-up post-discharge
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1 denotes survival while 0 denotes the participant passed away
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1-month follow-up post-discharge
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Readmission
Periodo de tiempo: 1-month follow-up post-discharge
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The number of readmission due to the index admission within 30 days post discharged
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1-month follow-up post-discharge
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Healthcare utilisation data and associated costs
Periodo de tiempo: 1-month follow-up post-discharge
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Number of visits (associated with index admission) to emergency department, specialist outpatient clinic, general practitioner and the associated costs within 30 days post-discharged
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1-month follow-up post-discharge
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Ambulatory status
Periodo de tiempo: 1-month follow-up post-discharge
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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
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1-month follow-up post-discharge
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Fall
Periodo de tiempo: 1-month follow-up post-discharge
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0 denotes no fall; 1 denotes fall(s) occured (within 30days post-discharged)
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1-month follow-up post-discharge
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Utilisation of community resources
Periodo de tiempo: 1-month follow-up post-discharge
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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
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1-month follow-up post-discharge
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Melanie Tan Dr, Ng Teng Fong General Hospital
- Investigador principal: Lau Lay Khoon Dr, Geriatric Education and Research Institute
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Durlak JA, DuPre EP. Implementation matters: a review of research on the influence of implementation on program outcomes and the factors affecting implementation. Am J Community Psychol. 2008 Jun;41(3-4):327-50. doi: 10.1007/s10464-008-9165-0.
- Graham ID, Logan J, Harrison MB, Straus SE, Tetroe J, Caswell W, Robinson N. Lost in knowledge translation: time for a map? J Contin Educ Health Prof. 2006 Winter;26(1):13-24. doi: 10.1002/chp.47.
- Olson EV, Johnson BJ, Thompson LF. The hazards of immobility. 1967. Am J Nurs. 1990 Mar;90(3):43-8. No abstract available.
- 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. doi: 10.1111/j.1532-5415.1990.tb03451.x.
- 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.
- 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.
- 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.
- Murray ME, Wells TJ, Callen BL. Hospital resource utilization and functional decline of geriatric patients. Nurs Econ. 2003 May-Jun;21(3):114-9. No abstract available.
- 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.
- 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.
- 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.
- Inouye SK, Bogardus ST Jr, Baker DI, Leo-Summers L, Cooney LM Jr. The Hospital Elder Life Program: a model of care to prevent cognitive and functional decline in older hospitalized patients. Hospital Elder Life Program. J Am Geriatr Soc. 2000 Dec;48(12):1697-706. doi: 10.1111/j.1532-5415.2000.tb03885.x.
- 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.
- 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.
- 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):61. doi: 10.3390/geriatrics3040061. Epub 2018 Sep 26.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. doi: 10.1177/0269215515607072. Epub 2015 Sep 22.
- 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.
- Lavis JN, Lomas J, Hamid M, Sewankambo NK. Assessing country-level efforts to link research to action. Bull World Health Organ. 2006 Aug;84(8):620-8. doi: 10.2471/blt.06.030312. Erratum In: Bull World Health Organ. 2006 Oct;84(10):840.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Anticipado)
25 de julio de 2022
Finalización primaria (Anticipado)
31 de enero de 2023
Finalización del estudio (Anticipado)
30 de septiembre de 2023
Fechas de registro del estudio
Enviado por primera vez
25 de junio de 2022
Primero enviado que cumplió con los criterios de control de calidad
1 de agosto de 2022
Publicado por primera vez (Actual)
2 de agosto de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de agosto de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
1 de agosto de 2022
Última verificación
1 de junio de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GERI1627
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Sí
Descripción del plan IPD
Working together with Geriatric Education and Research Institute and National Healthcare Group (Health Services & Outcomes Research).
Marco de tiempo para compartir IPD
During study period.
Criterios de acceso compartido de IPD
Via secure platforms (files to be encrypted with password).
For the purposes of data sharing and data analysis.
Tipo de información de apoyo para compartir IPD
- Protocolo de estudio
- Plan de Análisis Estadístico (SAP)
- Formulario de consentimiento informado (ICF)
- Informe de estudio clínico (CSR)
- Código analítico
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .