- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03330509
Effectiveness of the Supportive and Palliative Care Review Kit (SPARK) for Cancer Patients in the Acute Hospital
Introduction
There is a rising need for palliative care services in Singapore due to a rapidly ageing population and an increasing incidence of cancer. Current existing resources are inadequate - novel models of care are needed to expand access to palliative care without requiring significantly more specialist palliative care manpower.
Oncologist-driven referrals to a palliative care consultation service is the norm worldwide, including Singapore. This results in variable access to palliative care due to differences in referral practices. Palliative care involvement is also often delayed. In this study, the investigators propose to test Supportive and Palliative care Review Kit (SPARK) - a novel integrated model of care in which the palliative care team co-rounds with the medical oncology team.
Specific Aims and Hypothesis
This study aims to evaluate the impact of SPARK compared to usual care. The study investigators hypothesize that SPARK will result in more advanced cancer patients having access to palliative care, and at the same time operate at lower net cost. The study investigators also hypothesize that the improved efficiency of SPARK will result in shorter hospital length of stay for stage 4 cancer patients.
Methods
A cluster randomized trial with step wedged design will be used to compare SPARK to usual care. Data will be collected on health services utilization and access to palliative care services. Net costs will also be compared between SPARK and usual care. Semi-structured interviews with patients and healthcare professionals will be used to explore differences in experiences of healthcare provision between both models of care.
Importance
Singapore has a rising prevalence of cancer patients who require palliative care input, but only a minority are able to access it at present. If the SPARK model of care proves to be a scalable and cost-effective way of expanding access to palliative care, more cancer patients can benefit from palliative care.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Singapore, Singapore, 169610
- National Cancer Centre Singapore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients admitted under the care of the medical oncology team in Singapore General Hospital will be included.
Exclusion Criteria:
- Patients below 21 years old.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cluster 1
Control: 1-4 months; SPARK intervention: 5-20 months
|
An integrated model of care (SPARK care) in which the palliative care team co-rounds with the medical oncology team, supporting them in their delivery of basic palliative care, seamlessly stepping in and out to deliver specialist palliative care directly to patients when needed.
|
|
Experimental: Cluster 2
Control: 1-8 months; SPARK intervention: 9-20 months
|
An integrated model of care (SPARK care) in which the palliative care team co-rounds with the medical oncology team, supporting them in their delivery of basic palliative care, seamlessly stepping in and out to deliver specialist palliative care directly to patients when needed.
|
|
Experimental: Cluster 3
Control: 1-12 months; SPARK intervention: 13-20 months
|
An integrated model of care (SPARK care) in which the palliative care team co-rounds with the medical oncology team, supporting them in their delivery of basic palliative care, seamlessly stepping in and out to deliver specialist palliative care directly to patients when needed.
|
|
Experimental: Cluster 4
Control: 1-16 months; SPARK intervention: 17-20 months
|
An integrated model of care (SPARK care) in which the palliative care team co-rounds with the medical oncology team, supporting them in their delivery of basic palliative care, seamlessly stepping in and out to deliver specialist palliative care directly to patients when needed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital length of stay
Time Frame: 6 months
|
Dates of hospital admission and discharge will be collected to measure hospital length of stay
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of days from hospital discharge to hospital readmission
Time Frame: 30 days
|
Date of hospital discharge and date of subsequent hospital admission, if any, will be collected to measure this outcome
|
30 days
|
|
Referral to palliative care services
Time Frame: 6 months
|
Presence of referral to hospital palliative care consult service, home hospice or other palliative care services will be recorded
|
6 months
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Nickolich MS, El-Jawahri A, Temel JS, LeBlanc TW. Discussing the Evidence for Upstream Palliative Care in Improving Outcomes in Advanced Cancer. Am Soc Clin Oncol Educ Book. 2016;35:e534-8. doi: 10.1200/EDBK_159224.
- Hui D, Bruera E. Models of integration of oncology and palliative care. Ann Palliat Med. 2015 Jul;4(3):89-98. doi: 10.3978/j.issn.2224-5820.2015.04.01.
- Yang GM, Zhou S, Xu Z, Goh SS, Zhu X, Chong DQ, Tan DS, Kanesvaran R, Yee AC, Neo PS, Cheung YB. Comparing the effect of a consult model versus an integrated palliative care and medical oncology co-rounding model on health care utilization in an acute hospital - an open-label stepped-wedge cluster-randomized trial. Palliat Med. 2021 Sep;35(8):1578-1589. doi: 10.1177/02692163211022957.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NRSMFSP17101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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