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Evaluation of the Singapura Program of All Inclusive Care for the Elderly (SingaPACE) Demonstration Project (SingaPACE)

15 aprile 2015 aggiornato da: Dr. David Matchar, National University of Singapore

Evaluation of the Singapura Program of All Inclusive Care for the Elderly

This is a RCT studying the effectiveness of the Singapore Program for All Inclusive Care for the Elderly (SingaPACE) demonstration project over a 36 month period. SingaPACE is modelled on the US PACE home and community based service that acts as an alternative to institutional care. The comparator is best referrals for care as currently arranged through the Agency for Integrated Care (AIC) and referred by medical social workers. This research aims to determine how the SingaPACE model of health and social care affects use of emergency and acute care hospital services, institutional care, the quality of life (QOL) and satisfaction of the participants aged 60+ and their caregivers.

The hypotheses to be tested are:

H01: The elderly in SingaPACE will have fewer admissions to accident & emergency (A&E) hospitalization than the elderly who are not in SingaPACE.

H02: The elderly in SingaPACE will have fewer admissions to acute care hospitalization than the elderly who are not in SingaPACE.

H03: The elderly in SingaPACE will delay first admission to institutionalized nursing home care more than the elderly who are not in SingaPACE.

H04: The elderly in SingaPACE clients will have a higher QOL compared to the elderly who are not in SingaPACE.

H05: Caregivers of the elderly in SingaPACE will have a lower care-giving burden compared to caregivers of the elderly who are not in SingaPACE.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

* Recruitment

Potential subjects will be identified from i) inpatients referred prior to discharge and ii) outpatients to medical social workers from Singapore General Hospital (SGH) and Alexandra Hospital (AH). After confirming study eligibility the medical social worker will inform the potential subject about the study; after obtaining informed consent, the medical social worker will make a telephone call to the Duke - NUS research fellow who will then carry out the randomization process, assigning the subject to either the intervention group or the control group.

* Sites

The SingaPACE program will be located at 298, Tiong Bahru Road, #15-01/06 Central Plaza and at NTUC Eldercare, Block 117, Bukit Merah View.

* Procedures

  • Randomization will be stratified at each recruitment site by gender, assuring equal numbers of men and women in each study arm; and by hospital assuring equal number of patients from SGH and AH in each study arm. 20 participants will enter the study (10 per arm) each month over a proposed 4-month recruitment period. If the recruitment rate is lower than expected, the recruitment period will be extended.
  • Individuals in the intervention group will have a program of services based on intake and ongoing evaluation using interRAI by the SingaPACE assessment team. Services included in the integrated available mix are:

    • Case management across the continuum of care
    • Medical care by the SingaPACE physician
    • Home nursing (e.g., for administering parenteral medication, wound care, assessment of health status, nutrition)
    • Home care (e.g., for assistance with ADL)
    • Physiotherapy
    • Occupational therapy
    • Psychosocial care and counseling by social workers
    • Transportation to care and support services
    • Emergency housing and beds - public hospital acute bed substitution

      24 hour doctor / nurse phone coverageIf individuals in the intervention group leave the SingaPACE program, they will still continue to be tracked as a part of intention-to-treat analysis. Patients who die over the 36 months will be counted as drop outs. While the program can have new replacements for patients who have died, new participants will not be counted as a part of the intervention group in this research study.

  • Individuals randomized to the control arm will be referred to the medical social worker for referral to community services as usual. The control group will be interviewed on their medical history, healthcare utilization and expenditure data. The data collected will be complemented by data that may be made available by the VWO providing home and community care to the control group. Such VWO data may possibly include assessments using RAF.

If participants from the control group switch from a VWO community care program to another VWO community care program, they will still continue to be tracked and included in the intention-to-treat analysis. For participants who die over the period of study, they will be counted as loss to follow-up.

The control group will receive community care services referred by the SGH MSW:

  • VWO community care
  • GPs
  • Polyclinics
  • Specialist Outpatient Clinics
  • Traditional Chinese Medicine or herbal treatments
  • Supportive care arrangements of the family, relatives and friends

    • All participants will be tracked over a 36-month period starting August 2011. Following the US PACE impact evaluation from 1998 observations of all patients will be made at the beginning of the intervention and follow up at 6 month intervals (Chatterji et al. 1998; Irvin, Massey and Dorsey 1997; White, Abel and Kidder, 2000).

Analysis The main outcome measure is number of EMT events, A&E events and acute care events over the 36 month period. This is the primary endpoint.

The secondary endpoints to be studied are time to first admission to nursing home over the 36 month period, LOS in A&E; LOS in acute care; patient QOL and satisfaction with care; monthly utilization and costs; healthcare expenditure (out-of-pocket) and financing; and caregiver satisfaction / well being. There will be both unadjusted and adjusted measures. For time to first admission to nursing home, survival analysis specifically Cox Proportional Hazards regressions and intention-to-treat analysis will be carried out.

Since our study tracks participants over a period of 36 months, the first potential concern is participants in the control group who may be lost to follow-up 6 months after discharge which is when the MSW will close the care management files for patients. After the 6 months, the control group may for various reasons cease to receive community care unless they are in a VWO program that has care management. To minimize this difficulty, the available coordinated care management VWOs in the Bukit Merah catchment area will be provided with the list of names of the control group for oversight. Should any of the participants drop out of a community care program, the care coordinators can assist in enrolling the older adult in another care program should the participant decide that s / he would like to continue in a care program.

Statistical justification and the means by which data will be analyzed and interpreted

For the hypothesis to be tested, H03: Frail elderly in SingaPACE will have delayed first admission to institutionalized residential care nursing home relative to the frail elderly who are not in SingaPACE, survival analysis will be carried out. Shoenfeld's formula gives the total number of first nursing home admissions necessary to achieve 80% power as a function of the hazard ratio 32/(log HR)2. Assuming a hazard ratio of 0.35, along with first admission probabilities of 20% and 50% in SingaPACE and non-SingaPACE groups respectively, approximately 28 total admissions and therefore total participants (40 in each group) will be needed.

For the hypotheses H01: The elderly in SingaPACE will tend to have fewer admissions to accident & emergency (A&E) hospitalization than the elderly who are not in SingaPACE; H02: The elderly in SingaPACE will have fewer admissions to acute care hospitalization than the elderly who are not in SingaPACE; H04: The elderly in SingaPACE clients will have an enhanced QOL and satisfaction compared to the elderly who are not in SingaPACE; and H05: Caregivers of the elderly in SingaPACE will have a lower care-giving burden compared to caregivers of the elderly who are not in SingaPACE, Wilcoxon rank sum tests will be carried out. Assuming that observations from one group will exceed observations from the other group at least 55% of the time, each of these tests will have greater than 80% power for detecting a difference between the groups.

The analytical strategy will consist of hypothesis testing for each of the five individual hypotheses and intention-to-treat analysis. Also there will be an examination of the distributions of the main outcomes across all participants in each arm over 36 months. This will be complemented by a meta-analysis of the effectiveness of PACE programs in the US and Singapore.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

80

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Singapore, Singapore
        • NTUC Eldercare
      • Singapore, Singapore
        • Tiong Bahru Central Plaza

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

60 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Individuals aged 60 and above;
  • The frail elderly classified as high Category2 - Category 3 under the Residence Assessment Form(RAF);
  • Are willing to enroll in SingaPACE if they were selected in a fair lottery draw or to be followed up similarly over 36 months if not selected;
  • Residing within the Bukit Merah catchment area;

Exclusion Criteria:

  • Bed Bound;
  • Are undergoing dialysis treatment,
  • Radiotherapy or chemotherapy; or
  • Have behavioral and psychological symptoms of dementia(BPSD)prior to enrollment in the research study.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Control Group
Individuals randomized into the control arm will receive usual community care services referred by the social worker from SGH and AH.
Sperimentale: Intervention Group
Individuals in the intervention group will go through an integrated program of community based health and social care based on intake and ongoing evaluation by the SingaPACE team.
Individuals in the intervention group will go through an integrated program of community based health and social care, based on intake and ongoing evaluation by the SingaPACE team.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of EMT and acute care events
Lasso di tempo: 36 months

The primary outcome measure will be the number of EMT events, A&E visits or acute care hospitalizations captured based on the following possible sequence of events:

  • The number of EMT events or
  • The number of EMT events leading to A&E events or
  • The number of EMT events leading to A&E events that lead to acute care hospitalizations or
  • The number of A&E events or
  • The number of A&E events that lead to acute care hospitalizations or
  • The number of acute care hospitalizations
36 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Admission to institutionalized nursing home
Lasso di tempo: 36 months
From randomization point, time to first admission to nursing home over the 36 month period
36 months
Length of stay in acute care
Lasso di tempo: 36 months
For each acute care hospitalization, the length of stay
36 months
Patient Quality of Life
Lasso di tempo: 36 months
Patient QOL assessed using EQ-5D at 6 month intervals for the given time frame
36 months
Caregiver burden
Lasso di tempo: 36 months
Using the Zarit Caregiver Burden measure, assess changes to caregiver (spouse, family members, friends) burden at 6 month intervals for the given time frame
36 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: David B Matchar, MD,FACP,FAHA, Duke-NUS Graduate Medical School

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 agosto 2011

Completamento primario (Effettivo)

1 luglio 2014

Completamento dello studio (Effettivo)

1 luglio 2014

Date di iscrizione allo studio

Primo inviato

29 marzo 2012

Primo inviato che soddisfa i criteri di controllo qualità

30 marzo 2012

Primo Inserito (Stima)

2 aprile 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

16 aprile 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 aprile 2015

Ultimo verificato

1 aprile 2015

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 2011/381/A (Altro identificatore: Singapore Health CIRB)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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