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

1. august 2022 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

90

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Singapore
      • Singapore, Singapore, 609606
        • Ng Teng Fong Hospital
        • Ta kontakt med:
        • Underetterforsker:
          • Seok Mei Lim Dr
        • Underetterforsker:
          • Dina Ee Dr
        • Underetterforsker:
          • Weng Kin Lai
        • Underetterforsker:
          • Russell Yoong
        • Underetterforsker:
          • Lydia Au Dr
        • Underetterforsker:
          • Bing Kit Chan
      • Singapore, Singapore, 768024
        • Geriatrics Education and Research Institute
        • Ta kontakt med:
        • Underetterforsker:
          • Tou Nien Xiang Dr
        • Underetterforsker:
          • Ding Yew Yoong Prof
        • Underetterforsker:
          • Michelle Jessica Pereira Dr

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

21 år til 110 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Intervention
Intervention group will receive a multicomponent, mobility-focused intervention during the course of inpatient admission.
Annen: 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.
Ingen inngripen: Control
The control group will receive usual care as per current ward practice.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in maximum distance walked
Tidsramme: 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)
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)
Mobilisation frequency
Tidsramme: Through the duration of admission
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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in modified barthel score
Tidsramme: 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
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
Change in gait speed
Tidsramme: Upon admission and at discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
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)
Inpatient length of stay and discharge location
Tidsramme: 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)
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)
Presence of common iatrogenic complications such as delirium, injurious falls, pressure ulcers, and venous thromboembolisms
Tidsramme: At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
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)
Gross amount of patient's bill during index admission, considering subsidy level
Tidsramme: At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
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)
The intervention related costs for group therapy
Tidsramme: At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
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)

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mortality
Tidsramme: 1-month follow-up post-discharge
1 denotes survival while 0 denotes the participant passed away
1-month follow-up post-discharge
Readmission
Tidsramme: 1-month follow-up post-discharge
The number of readmission due to the index admission within 30 days post discharged
1-month follow-up post-discharge
Healthcare utilisation data and associated costs
Tidsramme: 1-month follow-up post-discharge
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
Ambulatory status
Tidsramme: 1-month follow-up post-discharge
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
Fall
Tidsramme: 1-month follow-up post-discharge
0 denotes no fall; 1 denotes fall(s) occured (within 30days post-discharged)
1-month follow-up post-discharge
Utilisation of community resources
Tidsramme: 1-month follow-up post-discharge
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

JurongHealth

Samarbeidspartnere

National Healthcare Group, Singapore
Geriatric Education and Research Institute

Etterforskere

  • Hovedetterforsker: Melanie Tan Dr, Ng Teng Fong General Hospital
  • Hovedetterforsker: Lau Lay Khoon Dr, Geriatric Education and Research Institute

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

25. juli 2022

Primær fullføring (Forventet)

31. januar 2023

Studiet fullført (Forventet)

30. september 2023

Datoer for studieregistrering

Først innsendt

25. juni 2022

Først innsendt som oppfylte QC-kriteriene

1. august 2022

Først lagt ut (Faktiske)

2. august 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. august 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. august 2022

Sist bekreftet

1. juni 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • GERI1627

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Ja

IPD-planbeskrivelse

Working together with Geriatric Education and Research Institute and National Healthcare Group (Health Services & Outcomes Research).

IPD-delingstidsramme

During study period.

Tilgangskriterier for IPD-deling

Via secure platforms (files to be encrypted with password). For the purposes of data sharing and data analysis.

IPD-deling Støtteinformasjonstype

  • Studieprotokoll
  • Statistisk analyseplan (SAP)
  • Informert samtykkeskjema (ICF)
  • Klinisk studierapport (CSR)
  • Analytisk kode

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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