Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01568801 |
| Other study ID # |
2011/381/A |
| Secondary ID |
2011/381/A |
| Status |
Completed |
| Phase |
N/A
|
| First received |
March 29, 2012 |
| Last updated |
April 15, 2015 |
| Start date |
August 2011 |
| Est. completion date |
July 2014 |
Study information
| Verified date |
April 2015 |
| Source |
National University, Singapore |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Singapore: Domain Specific Review Boards |
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
* 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.
