Health Care Coach Support in Reducing Acute Care Use and Cost in Patients With Cancer
Primary Purpose
Acute Myeloid Leukemia, Brain Glioblastoma, Estrogen Receptor Negative
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Laboratory Biomarker Analysis
Supportive Care
Survey Administration
Sponsored by
About this trial
This is an interventional health services research trial for Acute Myeloid Leukemia
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed patients for the following conditions
- Colon cancer stage III and IV
- Rectal cancer stage II, III, IV
- Glioblastoma multiforme (brain) -- no stage
- Non-small cell lung cancer stage IIIA, IIIB, IV
- Small cell lung cancer, limited stage and extensive stage
- Castration-resistant prostate cancer
- Head and neck cancer stage III and IV
- Gastric cancer stage III and IV
- Esophageal cancer stage III and IV
- Pancreatic cancer stage II, III, IV
- Renal cell carcinoma, stage IV
- Breast cancer, stage IV, if triple negative ER/PR/H2N negative or on systemic chemotherapy
- Sarcoma, stage IV
- Bladder carcinoma, stage IV
- Acute myeloid leukemia
- Melanoma, stage III and IV
- Ovarian cancer, stage III and IV
- High grade myelodysplastic syndrome (MDS)
- Any patient with recurrent or progressive cancer
- Patients must have the ability to understand and willingness to sign a written informed consent document
- Patient must have ongoing oncologic needs and plan to receive all care at the study institution and not already be in hospice or home-care
Exclusion Criteria:
- Patients must have capacity to consent
- Pregnant patients are excluded
Sites / Locations
- Virginia K Crosson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm A (usual care)
Arm B (health care coach support)
Arm Description
Patients receive usual care.
Patients undergo health care coach support with a baseline introduction (either telephonic or in-person) of the program followed by a visit (telephonic or in-person) with the health care coach after the first oncology appointment to discuss goals of care. The health care coach will contact patient based on patients' ongoing needs (weekly to monthly) and will conduct symptom assessments based on patients' treatment plans and symptoms.
Outcomes
Primary Outcome Measures
Emergency Department Visit (Chart Review)
Emergency Department use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment. We will evaluate comparisons of emergency department visits between study arms.
Hospitalization Visits (Chart Review)
Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment. We will evaluate comparisons of hospitalizations between the two study arms.
Secondary Outcome Measures
Change in patient satisfaction with care and decision making among patients undergoing health care coach support as assessed by Consumer Assessment of Healthcare Providers and Systems-G and Patient Satisfaction with Decision Scale
Each patient will receive a satisfaction with decision-making survey (The Satisfaction with Decision Survey) at 3 months, 6 months, 9 months, and 12 months.
Change in patient satisfaction with care among patients undergoing health care coach support as assessed by Consumer Assessment of Healthcare Providers and Systems-G.
Each patient will receive a satisfaction with care survey (The Consumer Assessment of Healthcare Providers and Systems-G) at 3 months, 6 months, 9 months, and 12 months.
Emergency Department Visit (Chart Review)
Emergency Department use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of emergency department visits between study arms.
Emergency Department Visit (Chart Review)
Emergency Department use for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of emergency department visits between study arms.
Hospitalization Visits (Chart Review)
Hospital use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of hospitalization use between study arms.
Hospitalization Visits (Chart Review)
Hospital use for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of hospitalization use between study arms.
Hospice Consult (Chart Review)
Hospice use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of hospice use between study arms.
Hospice Consult (Chart Review)
Hospice use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of hospice use between study arms.
Hospice Consult (Chart Review)
Hospice use for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of hospice use between study arms.
Palliative Care Consult (Chart Review)
Palliative Care consult for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of palliative care use between study arms.
Palliative Care Consult (Chart Review)
Palliative Care consult for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of palliative care use between study arms.
Palliative Care Consult (Chart Review)
Palliative Care consult for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of palliative care use between study arms.
Full Information
NCT ID
NCT03154190
First Posted
November 14, 2016
Last Updated
January 31, 2022
Sponsor
Stanford University
1. Study Identification
Unique Protocol Identification Number
NCT03154190
Brief Title
Health Care Coach Support in Reducing Acute Care Use and Cost in Patients With Cancer
Official Title
St. Judes-Stanford Comprehensive Support Initiative
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 8, 2017 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
August 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This randomized pilot clinical trial studies health care coach support in reducing acute care use and cost in patients with cancer. Health care coach support may help cancer patients to make decisions about their care that matches what is important to them with symptom management.
Detailed Description
PRIMARY OBJECTIVES:
I. To reduce acute care utilization by 2-5% for advanced cancer patients by training and deploying health care coaches who help patients and families discuss care goals, virtual modalities, engage in shared-decision-making, and participate in educational activities.
SECONDARY OBJECTIVES:
I. To improve patients' experience of their care. II. Improve patient understanding of advanced care planning. III. To improve the receipt of goal concordant care. IV. To reduce total healthcare costs.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive usual care.
ARM B: Patients undergo health care coach support with a baseline introduction (either telephonic or in-person) of the program followed by a visit (telephonic or in-person) with the health care coach after the first oncology appointment to discuss goals of care. The health care coach will contact patient based on patients' ongoing needs (weekly to monthly) and will conduct symptom assessments based on patients' treatment plans and symptoms.
After completion of study, patients are followed up for 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Brain Glioblastoma, Estrogen Receptor Negative, Extensive Stage Small Cell Lung Carcinoma, Head and Neck Carcinoma, HER2/Neu Negative, Hormone-Resistant Prostate Cancer, Limited Stage Small Cell Lung Carcinoma, Myelodysplastic Syndrome, Progesterone Receptor Negative, Progressive Disease, Recurrent Carcinoma, Stage II Pancreatic Cancer, Stage II Rectal Cancer, Stage IIA Pancreatic Cancer, Stage IIA Rectal Cancer, Stage IIB Pancreatic Cancer, Stage IIB Rectal Cancer, Stage IIC Rectal Cancer, Stage III Colon Cancer, Stage III Esophageal Cancer, Stage III Gastric Cancer, Stage III Non-Small Cell Lung Cancer, Stage III Ovarian Cancer, Stage III Pancreatic Cancer, Stage III Rectal Cancer, Stage III Skin Melanoma, Stage IIIA Colon Cancer, Stage IIIA Esophageal Cancer, Stage IIIA Gastric Cancer, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIA Ovarian Cancer, Stage IIIA Rectal Cancer, Stage IIIA Skin Melanoma, Stage IIIB Colon Cancer, Stage IIIB Esophageal Cancer, Stage IIIB Gastric Cancer, Stage IIIB Non-Small Cell Lung Cancer, Stage IIIB Ovarian Cancer, Stage IIIB Rectal Cancer, Stage IIIB Skin Melanoma, Stage IIIC Colon Cancer, Stage IIIC Esophageal Cancer, Stage IIIC Gastric Cancer, Stage IIIC Ovarian Cancer, Stage IIIC Rectal Cancer, Stage IIIC Skin Melanoma, Stage IV Bladder Cancer, Stage IV Bone Sarcoma, Stage IV Breast Cancer, Stage IV Colon Cancer, Stage IV Esophageal Cancer, Stage IV Gastric Cancer, Stage IV Non-Small Cell Lung Cancer, Stage IV Ovarian Cancer, Stage IV Pancreatic Cancer, Stage IV Rectal Cancer, Stage IV Renal Cell Cancer, Stage IV Skin Melanoma, Stage IV Soft Tissue Sarcoma, Stage IVA Bone Sarcoma, Stage IVA Colon Cancer, Stage IVA Rectal Cancer, Stage IVB Bone Sarcoma, Stage IVB Colon Cancer, Stage IVB Rectal Cancer, Triple-Negative Breast Carcinoma
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A (usual care)
Arm Type
Active Comparator
Arm Description
Patients receive usual care.
Arm Title
Arm B (health care coach support)
Arm Type
Experimental
Arm Description
Patients undergo health care coach support with a baseline introduction (either telephonic or in-person) of the program followed by a visit (telephonic or in-person) with the health care coach after the first oncology appointment to discuss goals of care. The health care coach will contact patient based on patients' ongoing needs (weekly to monthly) and will conduct symptom assessments based on patients' treatment plans and symptoms.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Receive usual care
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Procedure
Intervention Name(s)
Supportive Care
Other Intervention Name(s)
Supportive Therapy, Symptom Management, Therapy, Supportive
Intervention Description
Undergo health care coach support
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Emergency Department Visit (Chart Review)
Description
Emergency Department use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment. We will evaluate comparisons of emergency department visits between study arms.
Time Frame
6 months after patient enrollment
Title
Hospitalization Visits (Chart Review)
Description
Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment. We will evaluate comparisons of hospitalizations between the two study arms.
Time Frame
6 months after patient enrollment
Secondary Outcome Measure Information:
Title
Change in patient satisfaction with care and decision making among patients undergoing health care coach support as assessed by Consumer Assessment of Healthcare Providers and Systems-G and Patient Satisfaction with Decision Scale
Description
Each patient will receive a satisfaction with decision-making survey (The Satisfaction with Decision Survey) at 3 months, 6 months, 9 months, and 12 months.
Time Frame
Change in patient satisfaction with care and decision making from 3 months to 6, 9, and 12 months
Title
Change in patient satisfaction with care among patients undergoing health care coach support as assessed by Consumer Assessment of Healthcare Providers and Systems-G.
Description
Each patient will receive a satisfaction with care survey (The Consumer Assessment of Healthcare Providers and Systems-G) at 3 months, 6 months, 9 months, and 12 months.
Time Frame
Change in patient satisfaction with care from 3 months to 6, 9, and 12 months
Title
Emergency Department Visit (Chart Review)
Description
Emergency Department use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of emergency department visits between study arms.
Time Frame
12 months after patient enrollment
Title
Emergency Department Visit (Chart Review)
Description
Emergency Department use for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of emergency department visits between study arms.
Time Frame
30 days prior to death
Title
Hospitalization Visits (Chart Review)
Description
Hospital use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of hospitalization use between study arms.
Time Frame
12 months after patient enrollment
Title
Hospitalization Visits (Chart Review)
Description
Hospital use for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of hospitalization use between study arms.
Time Frame
30 days prior to death
Title
Hospice Consult (Chart Review)
Description
Hospice use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of hospice use between study arms.
Time Frame
6 months after patient enrollment
Title
Hospice Consult (Chart Review)
Description
Hospice use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of hospice use between study arms.
Time Frame
12 months after patient enrollment
Title
Hospice Consult (Chart Review)
Description
Hospice use for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of hospice use between study arms.
Time Frame
30 days prior to death
Title
Palliative Care Consult (Chart Review)
Description
Palliative Care consult for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of palliative care use between study arms.
Time Frame
6 months after patient enrollment
Title
Palliative Care Consult (Chart Review)
Description
Palliative Care consult for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of palliative care use between study arms.
Time Frame
12 months after patient enrollment
Title
Palliative Care Consult (Chart Review)
Description
Palliative Care consult for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of palliative care use between study arms.
Time Frame
30 days prior to death
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed patients for the following conditions
Colon cancer stage III and IV
Rectal cancer stage II, III, IV
Glioblastoma multiforme (brain) -- no stage
Non-small cell lung cancer stage IIIA, IIIB, IV
Small cell lung cancer, limited stage and extensive stage
Castration-resistant prostate cancer
Head and neck cancer stage III and IV
Gastric cancer stage III and IV
Esophageal cancer stage III and IV
Pancreatic cancer stage II, III, IV
Renal cell carcinoma, stage IV
Breast cancer, stage IV, if triple negative ER/PR/H2N negative or on systemic chemotherapy
Sarcoma, stage IV
Bladder carcinoma, stage IV
Acute myeloid leukemia
Melanoma, stage III and IV
Ovarian cancer, stage III and IV
High grade myelodysplastic syndrome (MDS)
Any patient with recurrent or progressive cancer
Patients must have the ability to understand and willingness to sign a written informed consent document
Patient must have ongoing oncologic needs and plan to receive all care at the study institution and not already be in hospice or home-care
Exclusion Criteria:
Patients must have capacity to consent
Pregnant patients are excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manali Patel
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia K Crosson Cancer Center
City
Fullerton
State/Province
California
ZIP/Postal Code
29835
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35771552
Citation
Patel MI, Kapphahn K, Dewland M, Aguilar V, Sanchez B, Sisay E, Murillo A, Smith K, Park DJ. Effect of a Community Health Worker Intervention on Acute Care Use, Advance Care Planning, and Patient-Reported Outcomes Among Adults With Advanced Stages of Cancer: A Randomized Clinical Trial. JAMA Oncol. 2022 Aug 1;8(8):1139-1148. doi: 10.1001/jamaoncol.2022.1997.
Results Reference
derived
PubMed Identifier
34749008
Citation
Patel MI, Aguilar V, Sanchez B, Sisay E, Park DJ. Health care coach support to assist with advance care planning and symptom management -A randomized controlled trial. Contemp Clin Trials. 2021 Dec;111:106617. doi: 10.1016/j.cct.2021.106617. Epub 2021 Nov 5.
Results Reference
derived
Learn more about this trial
Health Care Coach Support in Reducing Acute Care Use and Cost in Patients With Cancer
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