Health Services ResearchNCT03330509
Effectiveness of the Supportive and Palliative Care Review Kit (SPARK) for Cancer Patients in the Acute Hospital
A study testing SPARK intervention in people with Health Services Research, run by National Cancer Centre, Singapore at 1 site in Singapore.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 to 110 years
- Conditions the study is for
- Health Services Research
- What is being tested?
- SPARK intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,514 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Dec 2017to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients admitted under the care of the medical oncology team in Singapore General Hospital will be included.
Who cannot join
- Patients below 21 years old.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Health Services Research
- Being tested
- SPARK intervention
- Keywords
- Palliative care, Consultation model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPARK interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cluster 1 | Experimental | Control: 1-4 months; SPARK intervention: 5-20 months Receives: Other: SPARK intervention |
| Cluster 2 | Experimental | Control: 1-8 months; SPARK intervention: 9-20 months Receives: Other: SPARK intervention |
| Cluster 3 | Experimental | Control: 1-12 months; SPARK intervention: 13-20 months Receives: Other: SPARK intervention |
| Cluster 4 | Experimental | Control: 1-16 months; SPARK intervention: 17-20 months Receives: Other: SPARK intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital length of stay
Dates of hospital admission and discharge will be collected to measure hospital length of stay
Measured: 6 months
Secondary outcomes (2)
Number of days from hospital discharge to hospital readmission
Date of hospital discharge and date of subsequent hospital admission, if any, will be collected to measure this outcome
Measured: 30 days
Referral to palliative care services
Presence of referral to hospital palliative care consult service, home hospice or other palliative care services will be recorded
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Dec 2017
- Primary completion30 Jun 2020
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Health Services ResearchStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A stepped-wedge design will be used for this study, unblinded due to practical challenges of blinding. There will be 4 teams (clusters) within the DMO inpatient service, each comprising a team of senior consultant physicians, middle level and junior doctors, and oncology nurses. This follows current team structures. During the intervention period, a palliative care physician and nurse will join the team as integrated members. The study will be conducted over 20 months from November 2017 to June 2019, with each cluster crossing over from 'usual care' to 'spark intervention' at 4-month intervals. Each cluster will be randomly assigned a specific timing of crossing over.
- Masking
- None (open label)
- Enrolment
- 7,514 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore General Hospital, Duke-NUS Graduate Medical School
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330509
- Sponsor's protocol ID
- NRSMFSP17101
- Status last verified
- Apr 2022
- First submitted
- 18 Oct 2017
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 27249764Hui 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.
PubMed 26231806Yang 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.
PubMed 34524044
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Supportive and Palliative Care Review Kit (SPARK) for Cancer Patients in the Acute Hospital
- ClinicalTrials.gov ID
- NCT03330509
- Acronym / sponsor ID
- NRSMFSP17101
- Conditions
- Health Services Research
- Keywords
- Palliative care, Consultation model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,514 participants (actual)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Collaborators
- Singapore General Hospital, Duke-NUS Graduate Medical School
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- A stepped-wedge design will be used for this study, unblinded due to practical challenges of blinding. There will be 4 teams (clusters) within the DMO inpatient service, each comprising a team of senior consultant physicians, middle level and junior doctors, and oncology nurses. This follows current team structures. During the intervention period, a palliative care physician and nurse will join the team as integrated members. The study will be conducted over 20 months from November 2017 to June 2019, with each cluster crossing over from 'usual care' to 'spark intervention' at 4-month intervals. Each cluster will be randomly assigned a specific timing of crossing over.
| Arm | Type | Receives |
|---|---|---|
| Cluster 1 | Experimental | Other: SPARK interventionControl: 1-4 months; SPARK intervention: 5-20 months |
| Cluster 2 | Experimental | Other: SPARK interventionControl: 1-8 months; SPARK intervention: 9-20 months |
| Cluster 3 | Experimental | Other: SPARK interventionControl: 1-12 months; SPARK intervention: 13-20 months |
| Cluster 4 | Experimental | Other: SPARK interventionControl: 1-16 months; SPARK intervention: 17-20 months |
Who may qualify
- Ages
- 21 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted under the care of the medical oncology team in Singapore General Hospital will be included.
Key exclusion criteria (1 listed)
- Patients below 21 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPARK interventionAn 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. | Other | Cluster 1, Cluster 2, Cluster 3, Cluster 4 |
Primary outcome
Hospital length of stay
Time frame: 6 months
Dates of hospital admission and discharge will be collected to measure hospital length of stay
2 secondary outcomes
Number of days from hospital discharge to hospital readmission
Time frame: 30 days
Referral to palliative care services
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Background: PubMed 27249764Nickolich 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.
- Background: PubMed 26231806Hui 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.
- Derived from this study: PubMed 34524044Yang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPARK intervention in people with Health Services Research, run by National Cancer Centre, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital length of stay (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03330509, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.