Advanced Cancer, Cancer of Unknown Origin, Colon Cancer, End of Life, Gastric Cancer, Glioblastoma Multiforme, Head and Neck Neoplasms, Kidney Cancer, Liver Cancer, Lung Neoplasm, Melanoma, Prostate Cancer, Rectum Cancer, Testicular Neoplasms
Conditions
Brief summary
The Engagement of Patients with Advanced Cancer is an intervention that utilizes well-trained lay health coaches to engage patients and their families in goals of care and shared decision-making after a diagnosis of advanced cancer. Although lay health workers have never been tested in this role, we hypothesize that lay health workers can feasibly improve goals of care documentation and help to reduce unwanted healthcare utilization at the end of life for Veterans diagnosed with new advanced stages of cancer and those diagnosed with recurrent disease.
Detailed description
VAPAHCS proposes to implement and evaluate several critical elements to be in alignment with the VHA's Strategic Goal and priority areas for FY2013. The Engagement of Patients with Advanced Cancer project is an innovative program that will strengthen provider-patient relationship and facilitate whole person care about matters important to Veterans with cancer and important to support network and family. The project is intended to help establish Goals of Care Plan with appropriate documentation, develop, deploy, and evaluate a model of care for persons with cancer that is intended to improve clinical outcomes and experience of care for individuals with advanced cancer who have advanced cancer (stages III, IV or recurrent disease). The intervention provides patients with lay health coaches who assist patients and their families in discussing goals of care and engage in shared-decision making. The goal of the project is to demonstrate that there is improved patient experiences, outcomes, and that the program helps to reduce utilization of health care resources at the end of life.
Interventions
BEHAVIORALEPAC
Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.
Sponsors
VA Palo Alto Health Care System
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed stage III or IV cancer * Recurrent disease (any stage) * Ability to consent to study
Exclusion criteria
* Patients who are unable to consent to study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Completed Goals of Care Documentation. We Will Evaluate if 75% of Patients in the Intervention Arm Have a Documented Goals of Care Titled Medical Note Within 6 Months of Patient Enrollment in the Study. | 6 months after each patient enrollment | Feasibility is defined as at least 75% of patients in the intervention arm with a documented Goals of Care titled medical note within 6 months of patient enrollment in the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization Visits (Chart Review) | 6 months after patient enrollment | Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment. |
| Hospice Referral (Chart Review) | 6 months after patient enrollment | Hospice referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment. |
| Emergency Department Visit (Chart Review) | 6 months after patient enrollment | Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment. |
| Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey | Change in Patient Satisfaction with Care from baseline to 6 months. | Each patient will receive a satisfaction with care survey (The Consumer Assessment of Health Care Providers and Systems - General (CAHPS)) at baseline and 6 months. We will measure the change in satisfaction from baseline to 6 months. Scores for satisfaction were assessed using the Consumer Assessment of Healthcare Providers and Systems-General survey question #18 which measured rating of health provider, on which scores range from 0 to 10, with higher ratings correspond to higher patient satisfaction. Scores for each group are averaged at baseline and at 6 months. |
| Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey | 6 months | Each patient will receive a validated satisfaction with decision-making survey (The Satisfaction with Decision Survey) at 6 months after study enrollment.Satisfaction with Decision was assessed with the use of the 6-question Satisfaction with Decision Scale, on which scores range from 0 to 5, with higher scores indicating better satisfaction with decision-making. Scores for each group are averaged at 6 months after study enrollment. |
| Palliative Care Referral (Chart Review) | 6 months after patient enrollment | Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment. |
Participant flow
Recruitment details
August 2013 recruitment for overall study through new patient visit screening, phone calls to patients prior to first oncology appointment, and referral by physicians when diagnosed with recurrent cancers. Recruitment completed in February 2015.
Participants by arm
| Arm | Count |
|---|---|
| A: Intervention Arm All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.
EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study. | 105 |
| B: Control Group Arm All participants randomized to Arm B will receive usual oncologic care. | 108 |
| Total | 213 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 6 Month Satisfaction Decision Survey | Death | 22 | 25 |
| 6 Month Satisfaction Decision Survey | Lost to Follow-up | 1 | 1 |
| 6 Month Satisfaction Decision Survey | Refused to Answer | 0 | 2 |
| 6 Month Satisfaction Decision Survey | Withdrawal by Subject | 2 | 3 |
| 6 Month Satisfaction Survey | Death | 36 | 33 |
| 6 Month Satisfaction Survey | Lost to Follow-up | 1 | 1 |
| 6 Month Satisfaction Survey | Refused to Answer | 8 | 11 |
| 6 Month Satisfaction Survey | Withdrawal by Subject | 2 | 3 |
| Baseline Satisfaction Survey | Death | 0 | 1 |
| Baseline Satisfaction Survey | Lost to Follow-up | 1 | 1 |
| Baseline Satisfaction Survey | Refused to Answer | 1 | 2 |
| Baseline Satisfaction Survey | Withdrawal by Subject | 2 | 3 |
| End of Life Utilization and Cost 15month | Patient Still Alive | 45 | 48 |
| End of Life Utilization and Cost 6 Month | Patient Still Alive | 69 | 75 |
Baseline characteristics
| Characteristic | A: Intervention Arm | B: Control Group Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 78 Participants | 72 Participants | 150 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 36 Participants | 63 Participants |
| Age, Continuous | 69.2 years STANDARD_DEVIATION 9.2 | 69.4 years STANDARD_DEVIATION 9.05 | 69.3 years STANDARD_DEVIATION 9.1 |
| Cancer Diagnosis Gastrointestinal | 26 Participants | 27 Participants | 53 Participants |
| Cancer Diagnosis Genitourinary | 8 Participants | 9 Participants | 17 Participants |
| Cancer Diagnosis Head and Neck | 16 Participants | 15 Participants | 31 Participants |
| Cancer Diagnosis Other | 7 Participants | 11 Participants | 18 Participants |
| Cancer Diagnosis Skin | 7 Participants | 7 Participants | 14 Participants |
| Cancer Diagnosis Thoracic | 41 Participants | 39 Participants | 80 Participants |
| Cancer Stage at Diagnosis I | 4 Participants | 3 Participants | 7 Participants |
| Cancer Stage at Diagnosis II | 12 Participants | 17 Participants | 29 Participants |
| Cancer Stage at Diagnosis III | 30 Participants | 29 Participants | 59 Participants |
| Cancer Stage at Diagnosis IV | 59 Participants | 59 Participants | 118 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 99 Participants | 97 Participants | 196 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 9 Participants | 13 Participants |
| Marital Status Married | 35 Participants | 40 Participants | 75 Participants |
| Marital Status Unmarried | 70 Participants | 68 Participants | 138 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 6 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 9 Participants | 13 Participants |
| Race (NIH/OMB) White | 82 Participants | 83 Participants | 165 Participants |
| Region of Enrollment United States | 105 participants | 108 participants | 213 participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 103 Participants | 108 Participants | 211 Participants |
| Total Baseline Health Care Costs | 14052 US Dollars | 11455 US Dollars | 13090 US Dollars |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 105 | 0 / 108 |
| serious Total, serious adverse events | 0 / 105 | 0 / 108 |
Outcome results
Primary
Number of Participants With Completed Goals of Care Documentation. We Will Evaluate if 75% of Patients in the Intervention Arm Have a Documented Goals of Care Titled Medical Note Within 6 Months of Patient Enrollment in the Study.
Feasibility is defined as at least 75% of patients in the intervention arm with a documented Goals of Care titled medical note within 6 months of patient enrollment in the study.
Time frame: 6 months after each patient enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A: Intervention Arm | Number of Participants With Completed Goals of Care Documentation. We Will Evaluate if 75% of Patients in the Intervention Arm Have a Documented Goals of Care Titled Medical Note Within 6 Months of Patient Enrollment in the Study. | 98 Participants |
| B: Control Group Arm | Number of Participants With Completed Goals of Care Documentation. We Will Evaluate if 75% of Patients in the Intervention Arm Have a Documented Goals of Care Titled Medical Note Within 6 Months of Patient Enrollment in the Study. | 26 Participants |
Secondary
Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey
Each patient will receive a satisfaction with care survey (The Consumer Assessment of Health Care Providers and Systems - General (CAHPS)) at baseline and 6 months. We will measure the change in satisfaction from baseline to 6 months. Scores for satisfaction were assessed using the Consumer Assessment of Healthcare Providers and Systems-General survey question #18 which measured rating of health provider, on which scores range from 0 to 10, with higher ratings correspond to higher patient satisfaction. Scores for each group are averaged at baseline and at 6 months.
Time frame: Change in Patient Satisfaction with Care from baseline to 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A: Intervention Arm | Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey | -0.54 units on a scale | Standard Deviation 2.4 |
| B: Control Group Arm | Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey | -0.99 units on a scale | Standard Deviation 2.4 |
Secondary
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.
Time frame: 6 months after patient enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A: Intervention Arm | Emergency Department Visit (Chart Review) | 0.74 visits | Standard Deviation 1.12 |
| B: Control Group Arm | Emergency Department Visit (Chart Review) | 0.78 visits | Standard Deviation 1.15 |
Secondary
Emergency Department Visit (Chart Review)
Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.
Time frame: 15 months after patient enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A: Intervention Arm | Emergency Department Visit (Chart Review) | 1.03 Visits | Standard Deviation 1.4 |
| B: Control Group Arm | Emergency Department Visit (Chart Review) | 1.20 Visits | Standard Deviation 1.53 |
Secondary
Hospice Referral (Chart Review)
Hospice referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.
Time frame: 6 months after patient enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A: Intervention Arm | Hospice Referral (Chart Review) | 32 Participants |
| B: Control Group Arm | Hospice Referral (Chart Review) | 16 Participants |
Secondary
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.
Time frame: 6 months after patient enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A: Intervention Arm | Hospitalization Visits (Chart Review) | 0.62 Visits | Standard Deviation 0.8 |
| B: Control Group Arm | Hospitalization Visits (Chart Review) | 0.56 Visits | Standard Deviation 0.89 |
Secondary
Hospitalization Visits (Chart Review)
Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.
Time frame: 15 months after patient enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A: Intervention Arm | Hospitalization Visits (Chart Review) | 0.75 Visits | Standard Deviation 0.94 |
| B: Control Group Arm | Hospitalization Visits (Chart Review) | 0.88 Visits | Standard Deviation 1.07 |
Secondary
Palliative Care Referral (Chart Review)
Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.
Time frame: 15 months after patient enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A: Intervention Arm | Palliative Care Referral (Chart Review) | 31 Participants |
| B: Control Group Arm | Palliative Care Referral (Chart Review) | 23 Participants |
Secondary
Palliative Care Referral (Chart Review)
Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.
Time frame: 6 months after patient enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A: Intervention Arm | Palliative Care Referral (Chart Review) | 31 Participants |
| B: Control Group Arm | Palliative Care Referral (Chart Review) | 24 Participants |
Secondary
Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey
Each patient will receive a validated satisfaction with decision-making survey (The Satisfaction with Decision Survey) at 6 months after study enrollment.Satisfaction with Decision was assessed with the use of the 6-question Satisfaction with Decision Scale, on which scores range from 0 to 5, with higher scores indicating better satisfaction with decision-making. Scores for each group are averaged at 6 months after study enrollment.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A: Intervention Arm | Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey | 4.73 units on a scale | Standard Deviation 0.61 |
| B: Control Group Arm | Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey | 4.15 units on a scale | Standard Deviation 1.02 |