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Effectiveness of the Supportive and Palliative Care Review Kit (SPARK) for Cancer Patients in the Acute Hospital

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03330509
Recruitment Status : Active, not recruiting
First Posted : November 6, 2017
Last Update Posted : January 27, 2020
Sponsor:
Collaborators:
Singapore General Hospital
Duke-NUS Graduate Medical School
Information provided by (Responsible Party):
National Cancer Centre, Singapore

Brief 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 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.


Condition or disease Intervention/treatment Phase
Health Services Research Other: SPARK intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7514 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Health Services Research
Official Title: Effectiveness of the Supportive and Palliative Care Review Kit (SPARK) for Cancer Patients in the Acute Hospital
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cluster 1
Control: 1-4 months; SPARK intervention: 5-20 months
Other: SPARK intervention
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
Other: SPARK intervention
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
Other: SPARK intervention
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
Other: SPARK intervention
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.




Primary Outcome Measures :
  1. Hospital length of stay [ Time Frame: 6 months ]
    Dates of hospital admission and discharge will be collected to measure hospital length of stay


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330509


Locations
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Singapore
National Cancer Centre Singapore
Singapore, Singapore, 169610
Sponsors and Collaborators
National Cancer Centre, Singapore
Singapore General Hospital
Duke-NUS Graduate Medical School
  Study Documents (Full-Text)

Documents provided by National Cancer Centre, Singapore:
Study Protocol  [PDF] October 31, 2017
Statistical Analysis Plan  [PDF] October 31, 2017

Publications:
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Responsible Party: National Cancer Centre, Singapore
ClinicalTrials.gov Identifier: NCT03330509    
Other Study ID Numbers: NRSMFSP17101
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Cancer Centre, Singapore:
Palliative care
Consultation model