The extremely limited use of palliative care in low resource settings exacerbates suffering in patients with life- limiting illnesses such as cancer. This is particularly a problem for patients living in rural areas where barriers to care are even more pronounced. These barriers include factors such as distance from a cancer center, lack of healthcare providers in rural communities, restrictive morphine access policies, lack of transportation and treatment costs. For these reasons, most patients living in rural communities never receive palliative care or even basic pain management. In recognition of the urgent need for palliative care in limited resource settings, the World Health Organization released the Palliative Care Toolkit as a resource that community members can use to deliver palliative care in their own communities. The toolkit provides evidence-based educational materials to manage the physical, emotional and practical challenges of life-threatening illnesses, along with data collection instruments to assess and manage patient needs. We will carry out a pragmatic clinical trial to evaluate implementation of a novel Pal-Care intervention that will leverage community health workers to facilitate the delivery of basic palliative care using the Palliative Care Toolkit. The study will be conducted at the Tata Medical Center in Kolkata India, among their patients who reside in the 24 Parganas region outside of Kolkata, India. With randomization at the patient level, there will be an intervention group which will receive home-based palliative care services from a community health worker trained in palliative care and a control group which will receive standard cancer-center based palliative care services.
Two specific aims will be evaluated within the study.
Aim 1 will be to evaluate implementation of the home-based palliative care intervention within the context of the RE-AIM Framework domains (e.g. Reach, Effectiveness, Adoption, Implementation and Maintenance). To evaluate this aim, we will triangulate data from multiple data sources, including pre-post surveys to evaluate the community health worker training, palliative care logs completed by navigators while delivering care, meeting minutes and post-intervention interviews with cancer center stakeholders (clinical team, health workers and patients/caregivers).
Aim 2 will be to evaluate outcomes of this intervention to determine its relative effects compared to a standard control group on diverse patient endpoints, including palliative care needs, symptom burden, quality of life and experience with care.

Public Health Relevance

The goal of this pragmatic clinical trial is to test and evaluate a home-based palliative care intervention for utilizing community health workers to facilitate the delivery of palliative care to cancer patients in rural India. The study builds upon use of the World Health Organization-endorsed ?Palliative Care Toolkit,? which provides a comprehensive suite of evidence-based materials for delivering palliative care in limited resource settings. For the Pal-Care intervention, two specific aims will be addressed to evaluate: 1) implementation of the intervention within the context of the RE-AIM Framework and 2) outcomes of this intervention to determine its relative effects compared to a standard control group on patients? palliative care needs, symptom burden, QOL and experience with care.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Exploratory/Developmental Grants (R21)
Project #
1R21CA252850-01
Application #
10041879
Study Section
Dissemination and Implementation Research in Health Study Section (DIRH)
Program Officer
Jensen, Roxanne Elaine
Project Start
2020-08-01
Project End
2022-07-31
Budget Start
2020-08-01
Budget End
2022-07-31
Support Year
1
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Medical University of South Carolina
Department
Type
DUNS #
183710748
City
Charleston
State
SC
Country
United States
Zip Code
29407